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

Pancreatic Fistula Clinical Trial

Official title:

A Prospective Randomized Comparison of Pancreatic Stump Closure Techniques Utilizing an Autologous Falciform Patch and Fibrin Glue Compared to Standard Closure Following Distal Pancreatectomy With or Without Splenectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00889213
• Other study ID #: 08D.229
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2009
• Last updated: August 5, 2014
• Start date: August 2008
• Est. completion date: December 2015

Study information

• Verified date: August 2014
• Source: Thomas Jefferson University
• Contact: Ernest L. Rosato, M.D.
• Phone: 215-955-8666
• Email: ernest.rosato[@]jefferson.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Distal Pancreatectomy Complications
• Falciform Patch Pancreatic Closure
• Fibrin Glue Pancreatic Closure
• Pancreatic Fistula

Intervention

Procedure:
• Falciform patch and fibrin glue application
Following standard surgical exploration, the pancreatic gland will be mobilized appropriately to the level of transaction in the pancreatic neck, body or tail. The gland may be divided by stapling device, electrocautery or sharp division. Suture material will be at the discretion of the surgeon but may include absorbable or non-absorbable braided on mono-filament. Those patients randomized to autologous falciform patch will have the falciform membrane harvested. The falciform patch will be laid over the suture line of the resected pancreatic stump and secured to the pancreatic capsule utilizing #4-0 PDS suture placed at 12, 3, 6, and 9 o'clock positions. Fibrin glue (Vitagel) will be utilized to fill the potential space within this membranous capsule. Fibrin glue will be prepared as per standard instructions. Drains will be placed in the splenic bed and/or adjacent to the stump of the pancreas for postoperative fluid evacuation.
• standard pancreatic closure
Following standard surgical exploration, the pancreatic gland will be mobilized appropriately to the level of transaction in the pancreatic neck, body or tail. The gland may be divided by stapling device, electrocautery or sharp division. Suture material will be at the discretion of the surgeon but may include absorbable or non-absorbable braided on mono-filament.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic fistula development post distal pancreatectomy		30 days post surgery	No
Secondary	Morbidity- wound infection,delayed gastric emptying,abscess formation		30 day	No
Secondary	Mortality		30 day	No
Secondary	Surgical re-intervention/percutaneous interventions		30 days	No