Objectives
This is a protocol for a Cochrane Review (intervention). The objectives are as follows:
To evaluate the effects of routine nasogastric decompression as compared to no nasogastric decompression after oesophagectomy. In the case of routine decompression, we will also aim to assess the effects of early versus late removal of the nasogastric tube.
Background
Description of the condition
Oesophageal cancer is one of the deadliest cancers worldwide. In 2018, oesophageal cancer was the sixth most common cause of cancer‐related death worldwide(Bray 2018), with 572,000 new cases and 509,000 death being reported in 2018 alone (Bray 2018).
Oesophageal cancer is histologically classified as squamous cell carcinoma or adenocarcinoma (Siewert 2007). Squamous cell carcinoma is the major subtype of oesophageal cancer in Asia, and adenocarcinoma is more common in Western countries. While squamous cell carcinoma is often distributed near the tracheal bifurcation, adenocarcinoma is usually located at the oesophagogastric junction (Siewert 2007). Due to the different features, oesophagogastric junction cancer is often defined separately from oesophageal cancer (Goetze 2019; Siewert 2007).
Although squamous cell carcinoma is sometimes treated by chemoradiotherapy, surgery still plays a major role in treatment strategy for both oesophageal cancer and oesophagogastric junction cancer (Ajani 2019; Lordick 2016). Oesophagectomy is indicated for people with resectable oesophageal cancer (located more than 5 cm from the cricopharyngeus) (Ajani 2019). Oesophagectomy is also a treatment option of choice for certain types of oesophagogastric junction cancer (Siewert type I or II) (Siewert 1987). After oesophagectomy, gastrointestinal continuity is restored by joining the remnant oesophagus and pulled‐up stomach (gastric conduit). If the stomach is not available, small bowel or colon is used for reconstruction. Some advantages of the jejunal graft are fewer anastomoses than the colonic graft and the potential for propulsive peristalsis of the conduit. However, jejunal graft length is limited by mesenteric arcades, which may be a risk of graft ischaemia (Irino 2017; Watanabe 2016). For colonic graft, advantages include longer graft length, larger volume, and potentially reduced reflux by preserving the ileocolic valve. However, because of the high variation in the anatomy of mesenteric vessels, graft ischaemia may occur (Irino 2017; Watanabe 2016). In contrast, due to its safety and technical simplicity, the stomach is generally the first choice as the conduit after oesophagectomy (Bakshi 2017; Orringer 2007).
The incidence of oesophagectomy‐related perioperative complications has been found to be over 60%, of which pulmonary complications (in particular, pneumonia) and anastomotic leakage accounted for the majority, and 30‐day mortality rate ranging from 1% to 3% (Low 2019; Van der Werf 2020). A variety of risk factors have been identified, such as past smoking, significant patient morbidity (especially cardio‐respiratory), sarcopenia, neoadjuvant therapy, level of anastomosis, reconstruction route, pyloric drainage, and hospital volume (Arya 2015; Kamarajah 2020; Nishigori 2016; Nishikawa 2018; Papaconstantinou 2020; Sathornviriyapong 2016; Uchihara 2018; Urschel 2001). As part of the strategies to reduce perioperative complications, a nasogastric tube is traditionally placed to drain the gastric contents to reduce intraluminal pressure and prevent anastomotic leakage and postoperative pulmonary complications (Weijs 2013).
See Appendix 1 for a glossary of terms.
Description of the intervention
The pros and cons of prophylactic decompression by nasogastric tubes after surgery of stomach, small intestine or colon have been described previously (Petrelli 1993; Wu 1994). Existing evidence indicated a widespread recognition that nasogastric tube placement after abdominal surgery may not be necessary for all because omission of tubes can result in a reduced risk for postoperative complications and shorter hospital stays (Rao 2011; Verma 2007; Wang 2015). However, it is important to note these research findings were derived from abdominal surgery as a whole and not targeted for people undergoing oesophagectomy.
For oesophagectomy, nasogastric tube is generally placed perioperatively. Surgeons often opt to keep the tube in place until they start to feed the patient with an aim to reduce postoperative complications (Hayashi 2019). However, there is lack of evidence regarding decompression by nasogastric tubes after oesophagectomy. Therefore, at present, procedural strategies involving nasogastric tube placement after oesophagectomy vary across clinical practice settings. Some facilities routinely decompress with nasogastric tubes after oesophagectomy, while others do not (Gambhir 2020; Jiang 2021; Menéndez‐Jiménez 2020; Nguyen 2009). In terms of the duration of decompression, it varies from a few days after surgery to almost a week. In fact, in studies involving fast‐track surgical programmes, implementation of nasogastric tube decompression varies from no tube replacement to early removal (Chen 2016; Jamel 2019; Shewale 2015).
How the intervention might work
Negative intrathoracic pressure increases bile reflux to the gastric conduit, which may regurgitate and eventually lead to aspiration pneumonia (Aly 2004). As a result, the incidence of pulmonary complications has been reported to be 10% to 20% (Low 2019; Van der Werf 2020). Delayed emptying of the denervated gastric conduit may increase intraluminal pressure, resulting in anastomotic dehiscence. The tip of the pulled‐up stomach has a potential risk of insufficient blood supply or venous drainage (Urschel 1995). Consequently, the incidence of anastomotic leakage has been reported to be 7% to 20% (Dent 2016; Low 2019; Markar 2015; Van der Werf 2020), which is much higher than other types of gut surgeries. Decompression by nasogastric tubes after oesophagectomy may lead to reduced accumulation of digestive fluid and suppressed over‐expanded gastric conduit. Thus, it may reduce the risk of pneumonia or anastomotic leakage. However, some studies also reported that the use of nasogastric tubes led to aspiration and increased pulmonary complications after oesophagectomy (Nguyen 2009); patient discomfort was also a commonly reported adverse event associated with their use (Mistry 2012). Therefore, it remains unclear as to the benefits and risks of nasogastric tube placement after oesophagectomy in reducing postoperative complications and how long it needs to be kept in place.
Why it is important to do this review
The recognition has become widespread with respect to improved outcomes when nasogastric tube placement is omitted following abdominal surgery (Verma 2007). However, such findings from abdominal surgery may not be applicable to oesophagectomy in that the digestive fluid may accumulate and increase intraluminal pressure of the gastric conduit more easily than usual abdominal surgeries, which eventually causes pulmonary complications and anastomotic leakage. So far, one systematic review has reported in 2017 (Weijs 2017). Since then, another randomised controlled trial (RCT) has been published in 2019 (Hayashi 2019), which was also unable to reach a conclusion regarding this issue. No robust conclusions have been reached regarding the need for nasogastric decompression after oesophagectomy. A comprehensive and systematic synthesis of available evidence through this Cochrane review is thus warranted in order to further clarify the efficacy and safety profile of nasogastric decompression after oesophagectomy.
Objectives
To evaluate the effects of routine nasogastric decompression as compared to no nasogastric decompression after oesophagectomy. In the case of routine decompression, we will also aim to assess the effects of early versus late removal of the nasogastric tube.
Methods
Criteria for considering studies for this review
Types of studies
We will include only RCTs, including both individually randomised and cluster‐randomised studies, with no restrictions regarding language, publication year or publication status (full texts or abstracts). We will exclude studies of cross‐over design since it is nearly impossible for the types of interventions of interest to be evaluated in cross‐over trials.
Types of participants
We will include adults aged 18 years or older with histologically proven squamous cell carcinomas or adenocarcinomas of the oesophagus or gastro‐oesophageal junction, who underwent oesophagectomy with gastric conduit reconstruction. All types of oesophagectomy will be included irrespective of technique or level of anastomosis.
Types of interventions
We will include the following comparisons:
routine nasogastric decompression versus no nasogastric decompression; or
early versus late removal of the nasogastric tube.
We will impose no restrictions on the types of nasogastric tube, management strategy (free drainage or aspiration), or the time of randomisation (before or after surgery).
For the comparison of routine versus no nasogastric decompression, our definition of routine nasogastric decompression will be that a nasogastric tube is inserted before or during surgery and it remains in place to decompress the intraluminal pressure after oesophagectomy. If the nasogastric tube is not used perioperatively or used only during operation and removed in the operating room, we will define the intervention as ‘no nasogastric decompression’.
For the comparison of early versus late removal of the nasogastric tube, the predefined duration is likely to be variable among studies because of lack of universal consensus. Therefore, we will include all studies comparing early to late removal of the nasogastric tube regardless of the cut‐off time point. We will explore any differences in cut‐off time in a subgroup analysis.
For studies involving co‐interventions, trials will be included in this study if co‐interventions are delivered to both the intervention and comparator groups. Any prophylactic or procedural analgesia or anti‐emetic therapy will be defined as standard care. However, we will present information on standard care strategies in the ‘Characteristics of included studies’ table.
Types of outcome measures
Primary outcomes
Anastomotic leakage (≤ 30 days after surgery or in hospital, Clavien‐Dindo classification (Dindo 2004): Grade II or more)
Postoperative pulmonary complications (≤ 30 days after surgery or in hospital, Clavien‐Dindo classification: Grade II or more)
For postoperative pulmonary complications, we will analyse the number of participants with at least one complication. If the number of participants is not available, we will attempt to contact the trial authors for further information. If still unsure, the highest number will be adopted among each reported pulmonary complication.
Secondary outcomes
Perioperative mortality (≤ 30 days after surgery or in hospital)
Postoperative hospital stay (days)
Nasogastric tube reinsertion (≤ 30 days after surgery or in hospital)
Patient discomfort or pain related to the tube (at time point closest to tube removal)
Patient discomfort or pain will be assessed by any generic scores (e.g. numerical rating scale or visual analog score where 0 is defined as 'no discomfort' and 10 for 'worst possible discomfort imaginable').
The definitions of these outcomes are likely to be different across included studies and we will summarise their precise definitions, as reported by study investigators, in the ‘Characteristics of included studies’ table in the full review.
If there is a trial with a classification of severity other than the Clavien‐Dindo classification, the outcome will be used for this analysis by classifying it according to the concepts of the Clavien‐Dindo classification. Outcomes without clear severity classification are clinically considered as ’complications requiring treatments’ and thus will be included in our analysis. If a trial reports complications of the severity equivalent to Clavien‐Dindo classification Grade III or higher, we will contact trial investigators.
For anastomotic leakage, postoperative pulmonary complications, perioperative mortality and nasogastric tube reinsertion, outcomes without clear definition of the time point measurement will be clinically considered as ’within 30 days after surgery or in hospital outcomes’ and thus will be included in our analysis. If there is a trial with a definition of the time point of measuring less than 30 days after surgery, it will be included in this analysis. However, if there is a trial with a definition of the time point of measuring over 30 days after surgery, the outcome will not be used for this analysis. If outcomes are reported at multiple time points, data collected at a the time point closest to 30 days will be used.
Reporting of the outcomes listed above will not be an inclusion criterion for the review.
Search methods for identification of studies
We will design the search strategies with assistance from the Cochrane Gut Information Specialist before performing literature searches. No restrictions will be placed on the language of publication when searching the electronic databases, or reviewing reference lists in identified studies.
Electronic searches
We will conduct electronic searches in the following bibliographic databases from inception to identify all published and unpublished studies.
Cochrane Central Register of Controlled Trials (CENTRAL) (via Ovid; Appendix 2);
MEDLINE via Ovid (1946 to present; Appendix 3); and
Embase via Ovid (1974 to present; Appendix 4).
We will arrange for translation of study reports published in languages other than English or Japanese before fully assessing their eligibility for inclusion in the review.
Searching other resources
We will check the reference lists of all primary studies and review articles for additional references that might have been missed in the primary searches. We will contact authors of identified trials and ask them to identify other published and unpublished studies. We will also contact manufacturers and experts in the field.
For ongoing studies, we will screen clinical trial registers including ClinicalTrials.gov (https://clinicaltrials.gov/) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) Search Portal (https://apps.who.int/trialsearch/), using terms related to oesophageal cancer and oesophagectomy and nasogastric tube.
We will search for errata or retractions from eligible trials on PubMed (www.ncbi.nlm.nih.gov/pubmed) and report the date this was done in the review. We will also identify grey literature via OpenGrey (http://www.opengrey.eu/).
Data collection and analysis
Selection of studies
Two review authors (HK and NS) will independently screen titles and abstracts for inclusion. All of the potential studies we identify as a result of the search will be coded as either 'retrieve' (eligible, potentially eligible, or unclear) or 'do not retrieve'. We will retrieve the full‐text reports of potentially eligible studies and the two review authors (HK and NS) will independently screen the full texts for further assessment against our a priori eligibility criteria. Reasons for exclusion of full‐text study reports will be clearly recorded. We will resolve any disagreement through discussion or, if required, by consulting a third author (NW). We will identify and exclude duplicate records and collate multiple reports of the same study according to the recommendations in the Cochrane Handbook for Systematic Reviews of Intervention (Higgins 2021). We will record the study selection process in sufficient detail to complete a Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) flow diagram, 'Characteristics of included studies' table and 'Characteristics of excluded studies' table.
Data extraction and management
We will use a pre‐standardised data collection form for extracting information on study characteristics and outcome data. This form will be piloted on at least one included study by two review authors (HK and NS) before proceeding to full‐scale data extraction.
The two authors (HK and NS) will independently extract the following study‐level information from included studies.
Study characteristics: design, number of study centres and location, number of arms, number of randomised participants, date of study.
Participants' characteristics: age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) status, past medical history, preoperative treatment, diagnosis, clinical stage, surgical approach (transthoracic/transhiatal), transthoracic approach (open/video‐assisted thoracoscopic surgery (VATS) (including hand‐assisted laparoscopic surgery (HALS))), abdominal approach (open/ laparoscopic (including HALS)), reconstruction route (anterior mediastinal/posterior mediastinal), site of anastomosis (cervical/intrathoracic), anastomosis method (hand‐sewing/stapler), pyloric drainage (gastroplasty, pyloromyotomy or pyloric finger fracture) (drainage/no drainage), feeding (yes/ no).
Interventions: types and details of interventions and comparators.
Outcomes: primary and secondary outcomes as specified and collected by study investigators, and their measurement time points.
Notes: funding for trial, notable conflicts of interest of trial authors.
We will note in the 'Characteristics of included studies' table if the study investigators reported outcome data in an unusable way. We will resolve disagreements by consensus or by involving a third review author (NW). One review author (HK) will enter data into the Review Manager 5 software (Review Manager 2014). Another author (NS) will double‐check that the study data are entered correctly by spot‐checking and comparing the study reports with how the data are actually entered/presented in the review.
Assessment of risk of bias in included studies
Two review authors (HK and NS) will independently assess the risk of bias in included studies using version 2 of Cochrane’s tool for assessing risk of bias in randomised trials (Risk of bias 2 (RoB 2)) as per the recommendations in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2021). All outcomes will be evaluated for risk of bias. We will assess the risk of bias based on the effect of assignment to the intervention at baseline (intention‐to‐treat effect).
This updated risk of bias tool is structured into five domains through which bias might be introduced into the result. The five domains for individually randomised trials are as follows.
Bias arising from the randomisation process.
Bias due to deviations from intended interventions.
Bias due to missing outcome data.
Bias in measurement of the outcome.
Bias in selection of the reported result.
We will respond to detailed signalling questions within each domain of bias using the following response options.
Yes.
Probably yes.
Probably no.
No.
No information.
Answers to signallng questions will be made available in additional tables.
Algorithms are in place to guide authors to a proposed risk of bias judgement for each domain as follows.
Low risk of bias.
Some concerns.
High risk of bias.
We will use the RoB 2 Excel tool to manage the assessment of risk of bias (available from: https://www.riskofbias.info/welcome/rob‐2‐0‐tool/current‐version‐of‐rob‐2). We will resolve differences during the assessment process through discussion or by involving a third review author (NW). We will summarise our judgments for each domain using a Risk of bias table.
We will judge overall risk of bias as 'low risk of bias' when the study is judged to be at low risk of bias for all domains. We will classify overall risk of bias as 'some concerns' when the study is judged to raise concerns in at least one domain but not judged to be at high risk of bias for any domain. We will classify overall risk of bias as 'high risk of bias' when the study is judged to be at high risk of bias in at least one domain or when the study is judged to have some concerns for multiple domains in a way that substantially lowers confidence in the review results.
Figures will be included to illustrate risk of bias, and our assessment will inform GRADE classification and the Summary of findings table.
Assessment of bias in conducting the systematic review
We will conduct the review according to this published protocol and report any deviations from it in the 'Differences between protocol and review' section of the full review.
Measures of treatment effect
We will analyse dichotomous data (e.g. pulmonary complications) using risk ratio (RRs) and risk difference (RD), continuous data (e.g. postoperative hospital stay) using mean differences (MDs) or standardised mean differences (SMDs) and report the corresponding 95% confidence intervals (CIs). We will ensure that higher scores for continuous outcomes have the same meaning for the particular outcome, explain the direction to the reader and report where the directions were reversed if this was necessary. We will define 'patient discomfort or pain scores' as a continuous outcome (not arbitrarily categorised) and use SMDs with 95% CIs following recommendations in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2021). We will delineate a positive SMD as showing much discomfort or pain. Regarding the effect size of the SMD, 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen 1988). In addition, we will express the SMD in the units of the measurement instruments mostly used by the included studies.
Unit of analysis issues
Each study rather than each report will be the unit of interest in the review. If we identify cluster‐RCTs, we will include them in the analyses along with individually randomised trials. We consider it reasonable to combine results from both types of RCTs if there is little heterogeneity among the study designs and if the interaction between the effects of interventions and the choice of randomisation unit is considered to be unlikely. We will adjust their sample sizes using the methods described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2021). We will estimate the intracluster correlation coefficient (ICC) from the trial (where possible), from a similar trial or from a study involving a similar population. If we use ICCs from other sources, we will report this and conduct a sensitivity analysis to investigate the effect of variation in the ICC.
Where multiple arms are reported in a single trial, we will include the relevant arms for subsequent analysis; if two comparisons are to be analysed in the same meta‐analysis, we will halve the control group to avoid double‐counting.
Dealing with missing data
We will contact trial investigators to verify key study characteristics and to obtain missing numerical outcome data as indicated (e.g. when a study is identified as abstract only). If we are unable to obtain the information from the study investigators or sponsors, we will impute the mean from the median (i.e. consider the median as the mean) and the standard deviation (SD) from the standard error (SE), interquartile range (IQR), or P values, according to guidance from the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2021). If we are unable to calculate the SD from SE, IQR, or P values, we will impute the SD as the highest SD in the remaining trials included in the outcome (Furukawa 2006). We are fully aware that this method of imputation will decrease the weight of the studies in the meta‐analysis of MD, and shift the effects towards no effect for the SMD.
As for missing outcome data for dichotomous outcomes, we will also contact the original investigators to request missing data. If we obtain any additional data, we will include them in the analysis. If some participants have missing data, we will only include the available data in the primary analysis. Also, we will consider imputing the missing data with replacement values, assuming all were poor or good outcomes, and will explore the effect of imputation with sensitivity analyses.
Assessment of heterogeneity
We will assess heterogeneity by evaluating whether there is good overlap of the 95% CIs from visual inspection of the forest plots. Chi‐squared test for heterogeneity will be included in the forest plots. A P value of 0.10 will be used to determine statistical significance. We will also use the I² statistic to quantify heterogeneity among the included studies in each analysis using the guidance from the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2021). We will judge heterogeneity based on the following ranges, as suggested by the handbook:
0% to 40%: might not be important;
30% to 60%: may represent moderate heterogeneity;
50% to 90%: may represent substantial heterogeneity;
75% to 100%: considerable heterogeneity.
We will further explore the reasons for this heterogeneity by pursuing prespecified subgroup analysis.
Assessment of reporting biases
If we are able to include more than 10 trials in a meta‐analysis, we will create and visually inspect a funnel plot to explore possible publication biases. We will also use Egger's test to quantify reporting bias (Egger 1997), with P < 0.05 defined as statistical significance.
Data synthesis
If we identify eligible studies enrolling a mixed group of participants (e.g. people with benign or malignant conditions indicated for oesophagectomy; replacement with gastric or colonic or small bowel conduit), we will extract and use subgroup data of malignant conditions or replacement with gastric conduit. If such subgroup data are not available from the study reports, we will contact the primary investigators to obtain missing subgroup data. Should this approach fail, we will include the studies of mixed participants in the main analysis for the maximum use of the available evidence. Then, we will perform a sensitivity analysis excluding studies with mixed groups.
We will only decide to conduct data pooling (i.e. meta‐analysis) when the participants, treatments and underlying clinical questions are similar enough for this analysis to make sense. We will perform meta‐analysis using the Review Manager software (Review Manager 2014). We will use a random‐effects model for data synthesis because we consider that the different eligible studies are likely to be evaluating different intervention effects, especially for surgical outcomes (DerSimonian 1986).
A common way for trialists to indicate they have obtained skewed data is by reporting medians and interquartile ranges (IQRs). If we encounter this, we will note clearly in the full review that the study data are skewed and we will consider the implications of this. We will interpret results carefully and consider performing a sensitivity analysis, excluding studies whose data are suspiciously skewed. Otherwise, we will not perform a meta‐analysis and relevant findings will be narratively presented instead.
Subgroup analysis and investigation of heterogeneity
We plan to carry out the following subgroup analyses for both comparisons:
reconstruction route (anterior mediastinal versus posterior mediastinal);
pyloric drainage (gastroplasty, pyloromyotomy or pyloric finger fracture versus no pyloric drainage);
site of anastomosis (cervical versus intrathoracic);
cut‐off time point of early versus late tube removal (within 48 hours versus over 48 hours versus unclear) (only applicable to the comparison of early versus late removal of the nasogastric tube).
These subgroup analyses will be performed for the following outcome measures:
anastomotic leakage;
postoperative pulmonary complications;
perioperative mortality.
The rationale for the choice of these subgroups is as follows:
the difference in reconstruction route may affect the outcomes (Urschel 2001; Yan 2022);
pyloric drainage procedures may affect gastric passage and bile reflux, which may result in different outcomes (Arya 2015; Urschel 2002);
the differences in site of anastomosis may affect the outcomes (Walther 2003; Gooszen 2018);
the definition of early versus late tube removal may be variable among studies. The particular time point of 48 hours was chosen because most surgeons withdraw the nasogastric tube after the first flatus, which is reported to occur three to five days after surgery (Verma 2007). This time point is also mentioned in the Enhanced Recovery After Surgery guidelines in oesophagectomy (Low 2019a).
We will use the formal statistical test available in Review Manager 2014 for subgroup differences in order to test for subgroup interactions.
Sensitivity analysis
We will perform the following sensitivity analyses for both comparisons to assess the robustness of our conclusions:
excluding trials judged to be high in 'overall risk of bias';
excluding cluster‐RCTs in which the adjusted effect estimates were not reported;
random‐effects models versus fixed‐effect models for data synthesis;
performing missing outcome data imputation, on the assumption that all were poor or good outcomes.
We will investigate the following prespecified outcomes in these sensitivity analyses:
anastomotic leakage;
postoperative pulmonary complications;
perioperative mortality.
Reaching conclusions
We will only derive our conclusions based on the findings from our quantitative or qualitative syntheses using trial data included in this review. We will avoid making recommendations for practice; our implications for research will give the readers a clear sense of the potential scope and focus of future research and highlight any challenges and uncertainties in the field.
Summary of findings and assessment of the certainty of the evidence
We will develop Summary of findings tables for both comparisons on the following outcomes:
anastomotic leakage;
postoperative pulmonary complications;
perioperative mortality;
postoperative hospital stay (days);
nasogastric tube reinsertion;
patient discomfort or pain (only applicable to the comparison of early versus late removal of the nasogastric tube).
The table will be created using the GRADEpro GDT software (GRADEpro GDT) and we will interpret the findings and certainty of the evidence as suggested in the informative statement guidance (Santesso 2020). We will use the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality/certainty of the body of evidence based on the studies that contributed data to the meta‐analyses for each outcome, classifying it as 'high', 'moderate', 'low' or 'very low'. We will use the methods and recommendations as described in Chapter 14 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2021). We will justify all decisions to downgrade or upgrade the certainty of the evidence in the footnotes of the Summary of findings table and, where necessary, provide comments to aid the reader's understanding of the review findings. We will consider whether there is additional outcome information that was not incorporated into the meta‐analyses, note this in the comments, and state if it supports or contradicts the information from the meta‐analyses.
Acknowledgements
Cochrane Gut supported the authors in the development of this protocol (Yuhong Yuan, Teo Quay, Frances Tse, Takeshi Kanno, Sarah Rhodes).
We would like to thank Francesco E Botelho and Rohin Mittal for their content expertise and Joey Kwong for language support during the initial development phase.
The following people conducted the editorial process for this article:
• Sign‐off Editor (final editorial decision): Grigoris Leontiadis, McMaster University, Canada
• Managing Editor (selected peer reviewers, provided comments, collated peer‐reviewer comments, provided editorial guidance to authors, edited the article): Lara Kahale, Cochrane Central Editorial Service
• Editorial Assistant (conducted editorial policy checks and supported editorial team): Leticia Rodrigues, Cochrane Central Editorial Service
• Copy Editor (copy‐editing and production): Anne Lethaby, Cochrane Gynaecology and Fertility Group
• Peer‐reviewers (provided comments and recommended an editorial decision): Steve McDonald, Information Specialist, Cochrane Australia (search); Kerry Dwan, Cochrane Methods Support Unit (methods); Alfretta Vanderheyden, Consumer reviewer UGPD group (consumer); Spyridon Davakis, MD, PhDc, Upper Gastrointestinal and General Surgery Unit, National and Kapodistrian University of Athens, Athens, Greece (clinical); James McK Manson, consultant surgeon, Swansea Hospitals, UK (retired) (clinical)
Appendices
Appendix 1. Glossary of terms
Adenocarcinoma: malignant tumour originating in glandular epithelium
Anastomotic: related to the surgical connection to maintain continuity between two hollow and tubular structures, e.g. blood vessels, or gastrointestinal tracts
Anastomotic leakage: a leak of luminal contents from a surgical joining
Bile: a dark green to yellowish‐brown fluid, produced by the liver that aids the digestion of lipids in the small intestine
Chemoradiotherapy: a treatment that combines chemotherapy with radiation therapy
Cricopharyngeus: a semi‐circular muscle located in the neck about three inches below the Adam's apple
Dehiscence: splitting open of organs or tissues and releasing of material
Denervated: deprived of a nerve supply
Enhanced Recovery After Surgery: a comprehensive strategy to maintain postoperative physiological function and to accelerate recovery after surgery. This involves multimodal elements aimed at optimisation of the key components in pre‐, per‐ and postoperative period
Oesophageal: related to the oesophagus
Oesophagectomy: a procedure where all or part of the oesophagus is surgically removed
Oesophagogastric junction: a transition from the oesophagus to the stomach
Fast‐track: a standardised multimodal approach that aims to reduce the surgical stress response and to improve postoperative recovery and functional return. This is the same concept as Enhanced Recovery After Surgery
Gastric conduit: the tubularised stomach as a conduit used as an oesophageal substitute after oesophagectomy
Histologically: related to the study of cell and tissue structure at the microscopic level
Intraluminal: occurring within, or introduced into the lumen
Intrathoracic pressure: the pressure within the pleural cavity. Normally, the pressure within the pleural cavity is slightly less than the atmospheric pressure.
Ischaemia: a serious problem where there is not enough blood flowing to a part of the body
Mesenteric arcades: mesentery is the membrane that connects the bowel to the back wall of the abdomen. A network of mesenteric blood vessels is distributed in the mesentery.
Nasogastric: the passage from the nose to the stomach
Peristalsis: the process of wavelike muscular walls contractions of the digestive tract that moves food and waste along
Pulmonary: related to the lung
Sarcopenia: loss of muscle mass, strength, and functional decline, with aging and disease
Appendix 2. Cochrane CENTRAL search strategy (Ovid)
exp Esophageal Neoplasms/
((esophag* or oesophag* or gastroesophag* junction or GE junction) adj3 (cancer* or carcinoma* or malignan* or tumor* or tumour* or neoplas* or adenocarcinoma*)).tw,kw.
1 or 2
exp General Surgery/
(surger* or surgical or operat* or resec* or incision* or resect* or excised or excision).tw,kw.
4 or 5
3 and 6
exp Esophagectomy/
(esophagectom* or oesophagectom*).tw,kw.
or/7‐9
exp Decompression/
exp Decompression, Surgical/
decompress*.tw,kw.
((stomach or gastric or gastro* or intragastric or nasogastr* or nasal or nose or nasoduoden* or nasojejun* or gastrointestinal or nasoenter*) and (tube* or intubat* or tubal)).tw,kw.
(g‐tube* or ng‐tube* or nj‐tube*).tw,kw.
or/11‐15
10 and 16
randomize
Appendix 3. MEDLINE search strategy (Ovid)
exp Esophageal Neoplasms/
((esophag* or oesophag* or gastroesophag* junction or GE junction) adj3 (cancer* or carcinoma* or malignan* or tumor* or tumour* or neoplas* or adenocarcinoma*)).tw,kw.
1 or 2
exp General Surgery/
(surger* or surgical or operat* or resec* or incision* or resect* or excised or excision).tw,kw.
4 or 5
3 and 6
exp Esophagectomy/
(esophagectom* or oesophagectom*).tw,kw.
or/7‐9
exp Decompression/
exp Decompression, Surgical/
decompress*.tw,kw.
((stomach or gastric or gastro* or intragastric or nasogastr* or nasal or nose or nasoduoden* or nasojejun* or gastrointestinal or nasoenter*) and (tube* or intubat* or tubal)).tw,kw.
(g‐tube* or ng‐tube* or nj‐tube*).tw,kw.
or/11‐15
10 and 16
randomized controlled trial.pt.
controlled clinical trial.pt.
random*.ab.
placebo.ab.
trial.ab.
groups.ab.
or/18‐23
exp animals/ not humans.sh.
24 not 25
17 and 26
Lines 18‐26. RCT filter: 'Cochrane Highly Sensitive Search Strategy for identifying randomized trials in MEDLINE: sensitivity‐maximizing version (2008 revision); Ovid format'.
We made the following minor revisions: we used 'random*' instead of 'randomized.ab' or 'randomly.ab.' to capture word variations such as 'randomised, randomization, random'; we removed 'drug therapy.fs.' from the above filter as this review is not related to drug therapy.
Appendix 4. Embase search strategy (Ovid)
exp esophagus tumor/
((esophag* or oesophag* or gastroesophag* junction or GE junction) adj3 (cancer* or carcinoma* or malignan* or tumor* or tumour* or neoplas* or adenocarcinoma*)).tw,kw.
1 or 2
exp surgery/
(surger* or surgical or operat* or resec* or incision* or resect* or excised or excision).tw,kw.
4 or 5
3 and 6
exp esophagus resection/
(esophagectom* or oesophagectom*).tw,kw.
or/7‐9
exp decompression/
exp decompression surgery/
decompress*.tw,kw.
((stomach or gastric or gastro* or intragastric or nasogastr* or nasal or nose or nasoduoden* or nasojejun* or gastrointestinal or nasoenter*) and (tube* or intubat* or tubal)).tw,kw.
(g‐tube* or ng‐tube* or nj‐tube*).tw,kw.
or/11‐15
10 and 16
random:.tw.
placebo:.mp.
double‐blind:.tw.
or/18‐20
exp animal/ not human/
21 not 22
17 and 23
Lines #18‐21, RCT filter. Hedge Best balance of sensitivity and specificity filter for identifying randomised trials in Embase. https://hiru.mcmaster.ca/hiru/HIRU_Hedges_EMBASE_Strategies.aspx
Contributions of authors
Conceiving the protocol: HK, NW Designing the protocol: HK, NW Co‐ordinating the protocol: HK, NS, DN, KH, ST, KO, NW Designing search strategies: HK, NW Writing the protocol: HK, NW Providing general advice on the protocol: HK, NS, DN, KH, ST, KO, NW
Sources of support
Internal sources
No sources of support provided
External sources
No sources of support provided
Declarations of interest
HK: none known
NS: none known
DN: none known
KH has received grants for research about the treatment of colorectal cancer from Kondou Kinen Medical Foundation, Mitsubishi Foundation, Senko Medical Instrument and the Japan Society for the Promotion of Science (JSPS KAKENHI). He has also received speaking fees from Johnson & Johnson, Covidien Japan and Otsuka Pharmaceutical Factory.
ST has received grants for research from the Japan Agency for Medical Research and Development, and the Japan Society for the Promotion of Science (JSPS KAKENHI). He has received lecture fees from Covidien, Johnson & Johnson, Conmed Japan, Olympus and Intuitive Surgical, Inc.
KO has received grants or research support from the Japan Society for the Promotion of Science (JSPS KAKENHI). He has received grants from Taiho Pharmaceuticals, consultant fees from Ethicon, Stryker, Olympus, Intuitive Surgical, and Medicaroid, and payment for lectures or moderators from Ethicon, Covidien Japan, Intuitive Surgical, Taiho Pharmaceuticals, Chugai Pharmaceuticals, Tsumura Pharmaceuticals, Miyarisan Pharmaceuticals, EA Pharma, Ono Pharmaceuticals, Medicon, Otsuka Pharmaceuticals, and Gunze Medical Japan.
NW works as a clinician in Soseikai General Hospital, Japan.
New
References
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