Secretin Infusion to Prevent Pancreatic Leaks Following Pancreatic Resection

NCT02160808 | Completed Phase 2 Results DMC

• 1 other identifier: D13208 TBG-01
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Injury of Body of Pancreas

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Biochemical Leak/Grade B Fistula/Grade C Fistula

  Outcome based on revised ISGPS Guidelines which require a three day drain amylase concentration greater than 3x the normal serum amylase concentration. Biochemical leaks are the mildest for of fistula which have no clinical consequence. Grade B fistula are more severe requiring usually percutaneous drainage placement. Grade C fistula are most severe resulting in significant morbidity and/or death.

  3 days

Secondary Outcomes (2)

• Number of Participants With Intra-operative Intervention, Subsequent Biochemical Leak or B/C Fistula After Drug Administration

  Through completion of intra-operative intervention and subsequent biochemical leak, B/C Fistula up to 30 days post-operatively

• Length of Hospitalization

  Duration of study - average 30 days

Study Arms (2)

Secretin

ACTIVE COMPARATOR

Stimulate pancreatic secretion

Drug: Secretin

Saline

PLACEBO COMPARATOR

Placebo should not stimulate the pancreas to release its fluids

Drug: Placebo

Interventions

Secretin DRUG

Drug to stimulate pancreatic secretion

Secretin

Placebo DRUG

Saline

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• Smith KD, Barth RJ, Colacchio TA, Chevalier JI, Bergmann LE, Purich ED, Gardner TB. Effect of intraoperative secretin on operative outcomes in pancreatic resection: A randomized controlled trial. Pancreatology. 2021 Apr;21(3):515-521. doi: 10.1016/j.pan.2021.02.002. Epub 2021 Feb 8.

  PMID: 33602643 DERIVED

MeSH Terms

Interventions

Secretin

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Timothy B. Gardner MD MS
• Organization: Dartmouth-Hitchcock Medical Center

timothy.b.gardner@hitchcock.org

603-650-6472

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: June 11, 2014
• Study Start: May 1, 2014
• Primary Completion: September 21, 2019
• Study Completion: September 21, 2019
• Last Updated: March 31, 2020
• Results First Posted: March 31, 2020

Record last verified: 2020-03

Locations

US (1)