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

Thomas Jefferson University

Status: Unknown

Conditions: Pancreatic Fistula; Distal Pancreatectomy Complications; Falciform Patch Pancreatic Closure; Fibrin Glue Pancreatic Closure

Treatments: Procedure: Falciform patch and fibrin glue application; Procedure: standard pancreatic closure

Study type: Interventional

Funder types: Other

Identifiers

NCT00889213

08D.229

Details and patient eligibility

About

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).

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Patch and glue arm

Experimental group

Description:

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

Treatment:

Procedure: Falciform patch and fibrin glue application

stapled /sutured pancreatic closure

Active Comparator group

Treatment:

Procedure: standard pancreatic closure