An Evaluation of a New Technique Utilizing a Biologic Glue and Tissue Patch to Seal the Cut Edge of the Pancreas Following Removal of the Tail of the Pancreas

Not Applicable

• Conditions: Distal Pancreatectomy Complications; Fibrin Glue Pancreatic Closure; Falciform Patch Pancreatic Closure; Pancreatic Fistula
• Interventions: Procedure: standard pancreatic closure; Procedure: Falciform patch and fibrin glue application

• Registration Number: NCT00889213
• Lead Sponsor: Thomas Jefferson University

Brief Summary

The purpose of this trial is to determine whether the use of an autologous falciform ligament patch combined with fibrin glue will reduce the rate of pancreatic fistula in patients completing distal pancreatectomy. The hypothesis for the current trial is: Autologous falciform patch closure with fibrin glue will result in a 50% decrease in fistula formation postoperatively. The primary end point will be the development of pancreatic fistula using the ISGPF definition of pancreatic fistula1. (Drain output of any measurable volume of fluid on or after postop day #3 with an amylase content greater than three times serum amylase). Secondary end points will include length of postoperative hospital stay, percutaneous intervention rates, re-operation rates, morbidity to include delayed gastric emptying, wound infection, intraabdominal abscess, postoperative hemorrhage and 30-day mortality.(Bassi C, Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: An international study group (ISGPF) definition. The Journal of Surgery, 2005;138:8-13).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-27
• Study First Posted: 2009-04-28
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-06
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

1. completion of a successful distal pancreatectomy with/without splenectomy
2. patient must have a pancreatic remnant in place
3. there must be a viable falciform ligament for creation of the autologous patch

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Exclusion Criteria

1. patients undergoing total pancreatectomy
2. patients undergoing distal pancreatectomy who have previously completed a right sided resection of the pancreatic head, uncinate and neck
3. failure to sign informed consent
4. pregnant patients
5. patients in whom previous surgery has eliminated the falciform ligament, i.e. previous liver resection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stapled /sutured pancreatic closure	standard pancreatic closure	-
Patch and glue arm	Falciform patch and fibrin glue application	Randomized patients to the patch and glue arm will undergo placement of a falciform ligament tissue patch and fibrin glue to the resection margin of the remnant pancreas following distal pancreatectomy

Primary Outcome Measures

Name	Time	Method
Pancreatic fistula development post distal pancreatectomy	30 days post surgery

Secondary Outcome Measures

Name	Time	Method
Morbidity- wound infection,delayed gastric emptying,abscess formation	30 day
Surgical re-intervention/percutaneous interventions	30 days
Mortality	30 day

Trial Locations

Locations (2)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States