CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 170 enrolled
Drug / intervention
Secretin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02160808
NCT02160808Phase 3Completed

Secretin Infusion to Prevent Pancreatic Leaks Following Pancreatic Resection

Dartmouth-Hitchcock Medical Center·interventional·Posted Jun 11, 2014·Updated Mar 31, 2020

In Brief

A Phase 3 clinical trial evaluating Secretin and Placebo for Injury of Body of Pancreas. Completed, enrolled 170 participants across 1 site.

Detailed Summary

Pancreatic leaks complicate pancreatic resection in approximately 20% of cases. The pancreatic anastomosis or repair has been referred to as the Achilles heel of pancreatic surgery. Unfortunately, despite recognition of this problem and multiple operative techniques proposed to prevent this complication, leaks continue to represent a major cause of morbidity for patients undergoing pancreatic surgery. Treatment of leaks often requires nutritional support with total parenteral nutrition to diminish the leak in addition to invasive interventions to contain the leak with drains, stents or in severe cases, reoperation. Experiential data suggest that intra-operative infusions of secretin, a naturally occurring hormone that stimulates bicarbonate release from the pancreas, following resection but just prior to abdomen closure, may identify a leak if present. If secretin can demonstrate evidence of leaking intra-operatively, the pancreatic duct leak may be able to be fixed prior to abdominal closure. The investigators aim to determine if giving an intra-operative infusion of secretin will allow for identification and treatment of leaks after pancreatic reconstruction and prior to abdominal closure, leading to a reduction in the rate of pancreatic anastomotic leaks requiring intervention. The investigators will perform a double-blind, randomized pilot study of 176 patients undergoing pancreatic resection (pancreaticoduodenectomy and distal pancreatectomy) at Dartmouth-Hitchcock Medical Center. 88 of those patients will receive an intra-operative secretin infusion prior to abdominal closure and 88 will receive a saline placebo. Our primary outcome of interest will be the rate of pancreas duct leaks in each group as measured by the concentration of amylase present in the surgical drains 3 days following surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 11, 2014
Enrollment StartMay 1, 2014
Primary CompletionSep 21, 2019
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 12.1 years ago

Interventions

Secretindrug

Drug to stimulate pancreatic secretion

Placebodrug