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. 2020 Mar 26;2020(3):CD010582. doi: 10.1002/14651858.CD010582.pub2

Singh 2012.

Methods Randomised, parallel‐group, open‐label, 2‐armed, non‐inferiority, active‐controlled trial
Settings: Hospital in India
 Duration of trial: January 2005 to December 2007
Participants Number randomised: 78 (NG 39, NJ 39)
 Number analysed: 78 (NG 39, NJ 39)
 Age: NG feed: 39.1 ± 16.7 years, NJ feed: 39.7 ± 12.3 years
 Gender (M/F): NG feed: 28/11, NJ feed: 25/14
Inclusion criteria: All patients with SAP admitted within 7 days of onset of pain were included
Definition of pancreatitis: Diagnosis was based on clinical features, raised amylase levels (3 times the reference), and evidence of acute pancreatitis on imaging studies, namely, ultrasonography and/or contrast enhanced computed tomographic scan of the abdomen
Scale of severity used: Severe AP was defined by at least 1 of the following criteria:
  • presence of 1 or more organ failure as defined by the Atlanta classification;

  • APACHE II score of 8 or higher;

  • CTSI greater than 7.


Scale of severity used: Standard criteria for diagnosis APACHE, CTSI, or Atlanta (organ failure)
Exclusion criteria:
  • Patient already on oral feeds at the time of presentation

  • Patients in shock (i.e. systolic blood pressure < 90 mmHg at the time of randomisation)

  • Unwilling to give consent to participate in the study

Interventions Intervention: NG feed (N = 39), tube placed in stomach
 Control: NJ feed (N = 39), tube placed in jejunum beyond ligament of Treitz
Days after admission the feeding was initiated: attempted to start feeding after 48 hours of admission
Days after admission the adequate calorie intake was achieved: all participants achieved nutrient requirement within 3 days from the start of feeding
Days between disease onset and initiation of feeding: 10 (4 to 23, NG tube); 11 (3 to 48, NJ tube)
Type of feed used: semi‐elemental
Method of insertion: bedside for NG feeding; endoscopic guidance for NJ feeding
Confirmation of correct position: air test and aspiration of gastric content (NG tube); radiologically (NJ tube)
Surgical treatment: NG feed (4), NJ feed (2)
Outcomes Outcomes sought and reported
  • Mortality

  • Organ failure (single or multiple) ‐ "defined according to Atlanta classification. Presence of shock (systolic blood pressure < 90 mm Hg), pulmonary insufficiency (Po2 ≤ 60 mm Hg), renal failure (serum creatinine ≥ 2 mg/dl), or gastrointestinal bleeding (> 500 ml/24 hour)"

  • Rate of infections (local or systemic), local infection diagnosed when organism noted on Gram stain or culture of necrotic pancreatic tissue

  • Success rate of the procedure (tube placed in the desired position)

  • Surgical intervention

  • Complications associated with the feeds ‐ aspiration, diarrhoea, etc.

  • Exacerbation of pain ‐ defined as "occurrence of pain requiring stopping of feeds and associated with increase in serum amylase at least twice the previous value"

  • Length of hospital stay


Outcomes sought but not reported
  • Complications associated with the procedure ‐ bleeding, perforation, sinusitis, etc.

  • Requirment for parenteral nutrition

  • Days taken to achieve full nutrition requirement ‐ adequate caloric intake, positive nitrogen balance, etc.

  • Duration of tube feeding

  • Duration of analgesic requirement after feeding tube placement


Outcomes not sought but reported
  • Days taken to achieve full nutrition requirement

  • Duration of tube feeding

  • Reported intestinal permeability

Notes Country: India
Funding: ICMR, New Delhi
Conflicts of interest: None
Retrospectively registered: CTRI/2009/091/000948
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote from report, "Randomization was done by a random number sequence generated by a statistician not associated with the conduct of the study. Block randomization with variable block size was used to generate random numbers"
Allocation concealment (selection bias) Low risk Quote from report, "The method of allocation concealment was the sequentially numbered, sealed, opaque envelopes technique."
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk This was an open‐label study as blinding is impractical. There is no evidence of differences in the care and management of patients in the two groups.
Blinding of outcome assessment (detection bias) 
 Objective outcomes Low risk Quote from report, "It was not possible to blind the present study because of the nature of the treatment arms. A statistician (blinded to the route of feeding) performed the statistical analyses on the outcome measures"
Blinding of outcome assessment (detection bias) 
 Subjective outcomes (pain) Low risk This was an open‐label study, and the reporting of pain could potentially have been affected by knowledge of the intervention. However, in this study pain had to be accompanied by an increase in serum amylase to fulfil the study definition of pain exacerbation.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All randomised participants were included in the final analysis.
Selective reporting (reporting bias) Low risk The trial was retrospectively registered at Clinical Trial Registry ‐ India. The prespecified outcomes in the methods were reported in the results.
Other bias Low risk Authors received funding from ICMR, which was not associated with the conduct of the study or data analysis. The authors reported no conflict of interest.

APACHE: acute physiology and chronic health evaluation
 BPM: beat per minute
 CRP: c reactive protein
 CT: computed tomography
 CTSI: computed tomography severity index
 ERCP: endoscopic retrograde cholangiopancreatography
 ES: endoscopic sphincterotomy
 HR: heart rate
 ICP: intracranial pressure
 ICU: intensive care unit
 IQR: interquartile range
 ITT: intention to treat
 MRCP: magnetic resonance cholangiopancreatography
 NG: nasogastric
 NJ: nasojejunal
 pCO2: partial pressure of carbon dioxide
 RR: respiratory rate
 SBP: systolic blood pressure
 VAS: visual analogue scale
 WBC: white blood cell