Secretin Infusion to Prevent Pancreatic Leaks Following Pancreatic Resection

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Injury of Body of Pancreas

In brief

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.

Key facts

Study ID

NCT02160808

Run by

Dartmouth-Hitchcock Medical Center

People needed

170

Starts

2014-05-01

Expected to finish

2019-09-21

Last updated by the study team

2020-03-31

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled for pancreatic surgery requiring pancreatic resection at DHMC
• Age greater than 18 years old
• Ability to provide written informed consent

You may not qualify if…

• Inability to provide written informed consent
• Current ongoing acute pancreatitis
• Pregnant or nursing mothers
• Any medical condition which in the judgment of the Investigator renders participation in this study medically inadvisable.
• Participation in an investigational clinical study for a drug or medical device within 30 days prior to Visit 1.

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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