Skip to main content
. 2013 Apr 30;2013(4):CD008370. doi: 10.1002/14651858.CD008370.pub3

Beguiristain 1995.

Methods Randomised clinical trial (parallel design)
Participants Country: Spain 
 Sample size: 35 
 Post‐randomisation drop‐out: not stated 
 Revised sample size: 35 
 Females: 10 (28.6%) 
 Mean age: 59.4 years 
 Malignancy: 30 (85.7%) 
 Chronic pancreatitis: 3 (8.6%) 
 Pancreatoduodenectomy: 35 (100%) 
 Follow‐up: not reported
Inclusion criteria:
1. Pancreaticoduodenectomy
Interventions The participants were randomly assigned to 2 groups 
 Group 1: somatostatin (n = 21) 
 Further details: continuous infusion 4.5 mg/day starting immediately after surgery for 7 days 
 Group 2: control (n = 14)
Outcomes The outcomes reported were mortality and perioperative morbidity
Notes Pancreatic fistula definition: drainage of at least 10 mL of fluid with an amylase concentration of more than 5 Somogyi units (grade A)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: this information was not available
Allocation concealment (selection bias) Unclear risk Comment: this information was not available
Blinding (performance bias and detection bias) 
 All outcomes High risk Comment: blinding was probably not performed
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: this information was not available
Selective reporting (reporting bias) High risk Comment: some important outcomes were not reported
Free of source of funding bias? Unclear risk Comment: this information was not available