ABSTRACT
BACKGROUND:
Self-expanding metal stents (SEMS) are used as a bridge to surgery for colon cancer patients as an alternative to emergency surgery. Currently, there is a paucity of literature from Saudi Arabia on the preoperative usage of SEMS.
OBJECTIVE:
Determine whether SEMS are associated with a higher rate of complications.
DESIGN:
Retrospective cohort study
SETTINGS:
Tertiary care hospital in Saudi Arabia.
PATIENTS AND METHODS:
In patients diagnosed with obstructing colon cancer, up-front surgical resection was compared with insertion of SEMS followed by surgical resection between the years 2009 and 2013.
MAIN OUTCOME MEASURES:
Rate of stent-related short-term complications. Secondary endpoint, postoperative complications.
SAMPLE SIZE:
65.
RESULTS:
Twenty-four (36.9%) patients underwent SEMS placement; 41 (63.1%) underwent primary surgery. The median (interquartile range) hospital stay was significantly higher among the SEMS group (13 [8.5] days versus 7 [3] days in the primary surgery group, P<.001). Five patients (20.8%) in the SEMS group developed complications: 2 (8.3%) perforations, 2 (8.3%) obstructions, and 1 (4.2%) stent migrations.
CONCLUSION:
SEMS is associated with longer hospital stays and short-term serious complications. Further research should be conducted, preferably with a larger sample size.
LIMITATIONS:
Retrospective design, small sample size.
CONFLICT OF INTEREST:
None.
INTRODUCTION
In the early 1990s, self-expanding metal stents (SEMS) were inserted for palliative purposes only in inoperable cases of malignant colon obstruction.3 With advancements in technology, SEMS are now used as a bridge to curative surgery.2 However, concerns about using SEMS were raised since there are serious complications associated with their usage that affect survival.3 Various studies report complications of SEMS, namely perforation (4.5%), migration (11%), and obstruction (12%).4 SEMS usage, however, is associated with a lower probability of stoma creation.5 There are no studies from Saudi Arabia about SEMS usage in obstructing colon cancer. This study aims to evaluate the rate of complications associated with SEMS usage.
PATIENTS AND METHODS
A retrospective chart review was conducted at King Khalid University Hospital in Riyadh, Saudi Arabia. From 2009 to 2013, a cohort of patients were diagnosed with obstructed colon cancer and underwent SEMS insertion then surgery, while the rest underwent up-front primary surgery. All procedures were done by either certified colorectal surgeons or acute care/general surgeons. Laparoscopy could not be offered most of the time if the patients had a distended bowel. All the patients underwent computed tomography prior to SEMS insertion or surgery. Patients who had cecal or rectal cancer causing obstruction were excluded. The data collected included demographics, pre-existing comorbidities, site of tumor, cancer stage, histopathology, stent complications, and surgical technique. Only colorectal surgeons performed laparoscopy resections. In addition, postoperative complications were also assessed, including surgical site infection, intensive care unit admissions, and median length of hospital stay. This study was approved by the Institutional Review Board/Ethics Committee.
Procedure of SEMS Insertion
For all the patients, gastroenterologists performed the endoscopic insertions of SEMS. Insertion was guided by fluoroscopy with the use of a guide wire. Uncovered (WallFlex) colonic stents 22 mm in diameter and 60 or 90 mm in length were used (Figure 1). The colon was prepared with a water-soluble enema prior to the procedure. The patients' vital signs and clinical conditions were monitored prior to, during, and after the procedure. Any adverse events were recorded and addressed.
Figure 1.
(A) Endoscopic stent placement over guide wire. (B) Post-stent placement fluoroscopy
The data was analyzed using IBM SPSS software version 25 (Armonk NY). The qualitative variables, such as gender, comorbidities, type of surgical approach, and postoperative complications, were reported as frequency (n) and percentage (%) and assessed by chi-square or Fisher exact tests, as appropriate. However, the quantitative variables, such as age, length of hospital stay, and total lymph nodes retrieved, were reported as mean and standard deviation or median (interquartile range), as appropriate, and they were assessed by independent t tests or Mann-Whitney U tests, as appropriate. A P value of <.05 was considered significant.
RESULTS
Of the 65 patients, 24 (36.9%) underwent SEMS placement; 41 (63.1%) underwent primary surgery (Table 1). The median (IQR, range) between stent placement and surgery was 3.0 (1, 1-5). All patients underwent curative surgical resections. Table 2 shows a significantly higher number of the patients (11 [45.8%]) who underwent SEMS had a laparoscopic surgical approach, whereas only 9 patients (22%) out of those who underwent primary surgery required a laparoscopic surgical approach (P=.004). Also, all laparoscopic procedures were performed by colorectal surgeons, and most open-approach cases were done by acute care surgeons and general surgeons.
Table 1.
Baseline characteristics stratified by management pathway (surgery only vs. stent followed by surgery).
| Variable | Primary surgery (n=41) (63.1) | SEMS (n=24) (36.9) | P value |
|---|---|---|---|
| Age (years) | 55.5 (13.5) | 59.5 (11.3) | .2 |
| Gender | .1 | ||
| Male | 14 (34.1) | 14 (58.3) | |
| Female | 27 (65.9) | 10 (41.7) | |
| Cardiovascular disease | 6 (14.6) | 4 (16.7) | .8 |
| Renal disease | 1 (2.4) | 3 (12.5) | .1 |
| Stroke | 2 (4.9) | 2 (8.3) | .6 |
| Diabetes | 13 (31.7) | 9 (37.5) | .6 |
| Hypertension | 17 (41.5) | 8 (33.3) | .5 |
| Site of tumor | .9 | ||
| Right colon | 4 (9.8) | 1 (4.2) | |
| Transverse colon | 3 (7.3) | 2 (8.3) | |
| Left colon | 9 (22.0) | 6 (25.0) | |
| Sigmoid | 7 (17.1) | 4 (16.7) | |
| Rectosigmoid | 18 (43.9) | 11 (45.8) | |
| Stage | .2 | ||
| I | 2 (4.9) | 0 (0) | |
| II | 18 (43.9) | 9 (37.5) | |
| III | 18 (43.9) | 9 (37.5) | |
| IV | 3 (7.3) | 6 (25) | |
| Perineural/lymphovascular invasion | 13 (31.7) | 7 (29.2) | .8 |
Data are number (%) or mean (standard deviation).
Table 2.
Type of surgical approach by the performing surgeons.
| Approach | Primary surgery | SEMS | |
|---|---|---|---|
| Colorectal | Laparoscopic | 9 (22%) | 11 (45.8%) |
| Open | 3 (7.3%) | 9 (37.5%) | |
| ACS/GS | Laparoscopic | 0 | 0 |
| Open | 29 (70.7%) | 4 (16.7%) | |
| Overall | Laparoscopic | 9 (22%) | 11 (45.8%) |
| Open | 32 (78%) | 13 (54.2%) |
Chi-square comparison of primary surgery vs SEMS, χ2=4.053, P=.04.
Seven cases were understaged due to inadequate lymph node sampling: 3 in the primary surgery group and 4 in the SEMS group (Table 3). The median total length of hospital stay was significantly higher—median 13.5 days (IQR 8.5)—among patients with SEMS, as compared to those who underwent only primary surgery—7 days (IQR 3) (P=.01). Of the total number of patients in the study, 57 (87.7%) were followed over 24 months; the rest were lost to follow-up after 6 months. Presumably, they sought chemotherapy treatment at other healthcare facilities.
Table 3.
Intraoperative outcomes, hospital stay, and follow-up duration for surgery only vs. stent followed by surgery.
| Variable | Primary surgery (n=41) | SEMS (n=24) | P value |
|---|---|---|---|
| Operative duration (minutes) | 190.0 (108, 600) | 216.0 (74.1, 96-378) | <.001 |
| Number of patients with ≥12 lymph nodes examined | 38 (92.7) | 20 (83.3) | |
| Number of patients with <12 lymph nodes examined | 3 (7.3) | 4 (16.7) | |
| Postoperative hospital stay (days) | 6.0 (2.0) | 5.0 (4.3) | <.001 |
| Total hospital stay (days) | 7 (3) | 13 (8.5) | <.001 |
Data are number (%), mean (standard deviation), or median (interquartile range, minimum-maximum). Statistical comparisons by independent t test or Mann whitney U test.
No significant difference was observed between the groups in postoperative adverse events (Table 4). Clavien-Dindo classification was used to assess the extent of severity in each group.6 We observed that out of the 24 patients in the SEMS group, 5 (20.8%) had stent-related complications, which included 2 (8.3%) perforations, 2 (8.3%) with obstructions, and 1 (4.2%) with stent migration. There was no incidence of failed insertion. Both patients who had stent-related perforations had to be admitted to the intensive care unit.
Table 4.
Postoperative complications and Clavien-Dindo classification.
| Primary surgery (n=41) | SEMS (n=24) | P value | |
|---|---|---|---|
| Surgical site infection | 2 (4.9) | 4 (16.7) | .1 |
| Postoperative ileus | 4 (9.8) | 0 (0) | .1 |
| UTI | 4 (9.8) | 1 (4.2) | .4 |
| Pneumonia | 1 (2.4) | 1 (4.2) | .7 |
| Deep vein thrombosis | 0 (0) | 2 (8.3) | .1 |
| ICU admission | 1 (2.4) | 2 (8.3) | .3 |
| Overall complication | 12 (29.3) | 10 (41.6) | .7 |
| According to Clavien-Dindo classification | |||
| Grade I | 4 (9.8) | 2 (8.3) | |
| Grade II | 6 (14.6) | 6 (25) | |
| Grade IIIa | 1 (2.4) | 0 | |
| Grade IIIb | 0 | 0 | |
| Grade IVa | 1 (2.4) | 2 (8.3) | |
| Grade IVb | 0 | 0 | |
| Grade V | 0 | 0 | |
Data are number (%).
DISCUSSION
In our study, a laparoscopic surgical approach was performed more frequently in the stent group when the obstruction was relieved. Acute care and general surgeons generally handled patients who were not stented because most of the open surgeries were done during on-call time by acute care surgery and general surgery. In contrast, certified colorectal surgeons did most of the SEMS group procedures and also performed all laparoscopic procedures. Our findings are comparable with the studies conducted by Law et al7 and Seung et al8 where surgery is electively planned after SEMS usage. In such reports, laparoscopy was the preferred surgical technique. Furthermore, another study suggests that if decompression by SEMS placement is insufficient, minimally invasive surgery is difficult.9
There was no significant difference in postoperative surgical complications in patients with preoperative stent placement as compared to those who had primary surgery. However, surgical site infection was higher among the SEMS group, 4 (16.7%), versus the primary surgery group, 2 (4.9%). All these complications occurred in the patients who had stent complications (perforation and obstruction) and had to have open surgery. Some reports failed to demonstrate a significant difference in the short-term outcomes between the two groups.4,10 Other studies revealed that stent placements for colon cancer are associated with reduced overall complications.11,12 One study reported a significant reduction in intensive care admission, wound infections, abdominal abscesses, and respiratory complications in the stent group.13
Another finding of the present study is that the stent group is associated with prolonged total hospitalization compared to the emergency surgery group, whereas the lengths of the postoperative hospital stays were significantly shorter in SEMS group. These results are similar to findings by Yang et al8 found that since bowel functions recover earlier in the SEMS group, their postoperative hospital stay is shorter. However, Arezzo et al,5 reported longer total hospital stays in the SEMS group and Kim et al14 who also reported a week's difference between the average hospital stay of the stent group and the surgery group.14 The probable reason for inconsistent results is the lack of standardized protocols for inpatient assessment before and after stent placement, clinical cancer staging, and preoperative bowel preparation.
Five patients (20%) who were managed with SEMS insertion developed stent-related complications—perforation, obstruction, and migration—which contributed to prolonged hospital stays. The two stent-related perforations were managed with intensive care unit admission and urgent open exploration. Our perforation rate was 8.3%, which is double the international acceptable rate of 4.5%.4 This is probably related to our learning curve experience. The obstruction and stent migration cases were managed with open exploration and had no significant postoperative consequences. These factors may have increased the total hospital stay after colonic stent placement. Moreover, the European Society for Gastrointestinal Endoscopy recommends SEMS placement as a bridge to surgery in malignant colonic obstruction, not as a standard treatment.15 The present study had limitations. It is retrospective and underpowered, and any significant differences between the two groups of the study could have been erroneously missed due to type 2 statistical errors. In conclusion, stent insertion was associated with a high rate of serious complications at our center, probably due to an initial learning curve experience.
ACKNOWLEDGMENT
The authors are grateful to the Deanship of Scientific Research, King Saud University for funding through Vice Deanship of Scientific Research Chairs.
Funding Statement
None.
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