Recruiting

Biologic Glue

Sponsor:

Thomas Jefferson University

Code:

NCT00889213

Conditions

Pancreatic Fistula

Distal Pancreatectomy Complications

Falciform Patch Pancreatic Closure

Fibrin Glue Pancreatic Closure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Falciform patch and fibrin glue application

standard pancreatic closure

Study Details

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).

Conditions

Pancreatic Fistula

Distal Pancreatectomy Complications

Falciform Patch Pancreatic Closure

Fibrin Glue Pancreatic Closure

Study ID

NCT00889213

Start date

Aug, 2008

Status verified date

Aug, 2014

Completion date

Dec, 2015

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

190 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Patch and glue arm

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

active comparator: stapled /sutured pancreatic closure

Interventions

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.

Primary outcome measure

  • Pancreatic fistula development post distal pancreatectomy [ Time Frame: 30 days post surgery ]

Central Contacts and Locations

Central contacts

Ernest L. Rosato, M.D.

215-955-8666ernest.rosato@jefferson.edu

Locations

University Hospitals Case Medical Center

Recruiting

Cleveland, Ohio, United States

Contacts

Jeffrey M Hardacre, MD

216-844-7047jeffrey.hardacre@UHospitals.org

Bridget Ermlich, RN

(216) 844-3602bridget.ermlich@UHospitals.org

Principal Investigator:

Jeffrey M Hardacre, MD

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Ernest L Rosato, M.D.

215-955-8666ernest.rosato@jefferson.edu

Principal Investigator:

Ernest L Rosato, M.D.

More Information

Sponsor

Thomas Jefferson University

Last update posted

Aug 6, 2014

Last verified

Aug, 2014

Keywords

  • pancreatectomy
  • fistula
  • fibrin glue
  • falciform patch
  • surgery
  • complications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2014-08-06.