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. 2013 Apr 30;2013(4):CD008370. doi: 10.1002/14651858.CD008370.pub3

Suc 2004.

Methods Randomised clinical trial (parallel design)
Participants Country: France 
 Sample size: 230 
 Post‐randomisation drop‐out: 0 
 Revised sample size: 230 
 Females: 99 (43%) 
 Mean age: 56.5 years 
 Malignancy: 154 (67%) 
 Chronic pancreatitis: 30 (13%) 
 Pancreatoduodenectomy: 177 (77%) 
 Follow‐up: not reported
Inclusion criteria: 
 1. Pancreatic resection was performed for either malignant or benign disease 
 2. Age more than 18 years
Exclusion criteria: 
 1. Resection for acute pancreatitis or trauma 
 2. Simple tumour excision 
 3. Total or central pancreatectomy 
 4. Pancreatoduodenectomy without immediate pancreatodigestive anastomosis 
 5. Duodenum‐preserving pancreatectomy
Interventions The participants were randomly assigned to 2 groups 
 Group 1: octreotide (n = 122) 
 Further details: 100 μg sc during the operation every 8 h for 10 days 
 Group 2: control (n = 108) 
 Further details: no treatment
Outcomes The outcomes reported were mortality, re‐operation, perioperative morbidity and hospital stay
Notes Pancreatic fistula definition: either chemically as fluid obtained through drains or percutaneous aspiration containing at least 4 times normal serum values of amylase for 3 days, irrespective of the amount of output and the date of appearance or clinically and radiologically as anastomotic leaks (type A, B, C ‐ not available separately)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "allotment to octreotide or not, as generated by computerized random number tables, was decided by a telephone call to the coordinating center which collected and processed all data"
Allocation concealment (selection bias) Low risk Quote: "allotment to octreotide or not, as generated by computerized random number tables, was decided by a telephone call to the coordinating center which collected and processed all data"
Blinding (performance bias and detection bias) 
 All outcomes High risk Quote: "patients were not aware of the treatment arm to which they were allotted (octreotide injection was considered as part of postoperative treatment), but the surgeon performing the operation, obviously, was (single‐blind study without placebo). Complications, however, were assessed by a physician who was unaware of the allotted treatment"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: there were no post‐randomisation drop‐outs
Selective reporting (reporting bias) Low risk Comment: all pre‐defined outcomes were reported
Free of source of funding bias? Unclear risk Comment: this information was not available