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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

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ClinicalTrials.gov Identifier: NCT00889213
Recruitment Status : Unknown
Verified August 2014 by Thomas Jefferson University.
Recruitment status was:  Recruiting
First Posted : April 28, 2009
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
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  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2008
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Pancreatic fistula development post distal pancreatectomy [ Time Frame: 30 days post surgery ]

Secondary Outcome Measures :
  1. Morbidity- wound infection,delayed gastric emptying,abscess formation [ Time Frame: 30 day ]
  2. Mortality [ Time Frame: 30 day ]
  3. Surgical re-intervention/percutaneous interventions [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014

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
Pancrelipase
Pancreatin
Fibrin Tissue Adhesive
Gastrointestinal Agents
Hemostatics
Coagulants