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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00889213
First received: April 27, 2009
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention
Pancreatic Fistula
Distal Pancreatectomy Complications
Falciform Patch Pancreatic Closure
Fibrin Glue Pancreatic Closure
Procedure: Falciform patch and fibrin glue application
Procedure: standard pancreatic closure

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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Pancreatic fistula development post distal pancreatectomy [ Time Frame: 30 days post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity- wound infection,delayed gastric emptying,abscess formation [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Surgical re-intervention/percutaneous interventions [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: August 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Active Comparator: stapled /sutured pancreatic closure Procedure: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889213

Contacts
Contact: Ernest L. Rosato, M.D. 215-955-8666 ernest.rosato@jefferson.edu

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States
Contact: Jeffrey M Hardacre, MD    216-844-7047    jeffrey.hardacre@UHospitals.org   
Contact: Bridget Ermlich, RN    (216) 844-3602    bridget.ermlich@UHospitals.org   
Principal Investigator: Jeffrey M Hardacre, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Ernest L Rosato, M.D.    215-955-8666    ernest.rosato@jefferson.edu   
Principal Investigator: Ernest L Rosato, M.D.         
Sub-Investigator: Charles J Yeo, M.D.         
Sub-Investigator: Adam Berger, M.D.         
Sub-Investigator: Karen Chojnacki, M.D.         
Sub-Investigator: Eugene Kennedy, M.D.         
Sub-Investigator: Francis E Rosato, M.D.         
Sub-Investigator: Bernadette Profetta, M.D.         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Ernest L Rosato, M.D. Thomas Jefferson University
  More Information

No publications provided by Thomas Jefferson University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00889213     History of Changes
Other Study ID Numbers: 08D.229
Study First Received: April 27, 2009
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
pancreatectomy
fistula
fibrin glue
falciform patch
surgery
complications

Additional relevant MeSH terms:
Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014