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NCT02160808 · ClinicalTrials.gov registry record · Phase 2

Secretin Infusion to Prevent Pancreatic Leaks Following Pancreatic Resection

A Phase 2 study, sponsored by Dartmouth-Hitchcock Medical Center.

Completed
Registry status
Phase 2
Development phase
170
Enrollment target

NCT02160808 is a Phase 2 study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 170 participants.

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The verdict

NCT02160808, a Phase 2 study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
170 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Secretin

Trial Details

FieldValue
Enrollment Target 170 participants
Start Date 2014-05
Est. Completion 2019-09-21
Phase Phase 2

Sponsor

Dartmouth-Hitchcock Medical Center

427 total trials

What the Registry Record Tells You About NCT02160808

The ClinicalTrials.gov registry entry for NCT02160808 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02160808 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02160808 about?

NCT02160808 is a clinical study titled "Secretin Infusion to Prevent Pancreatic Leaks Following Pancreatic Resection". 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 complica...

What is the current status of trial NCT02160808?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2014-05. Estimated completion is 2019-09-21.

What interventions are being tested in trial NCT02160808?

The interventions under investigation include: Placebo (DRUG), Secretin (DRUG).

Who is sponsoring clinical trial NCT02160808?

This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.