Pancreas Resection With and Without Drains

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
William E Fisher, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01441492
First received: September 23, 2011
Last updated: January 15, 2016
Last verified: January 2016
  Purpose
This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.

Condition Intervention Phase
Pancreas Tumor
Pancreatitis
Procedure: No Drains
Procedure: Drains
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • The primary outcome measure is the incidence of > grade I complications. [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of specific complications [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • Severity of complications [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    The mean complication severity grade for each study group will be compared

  • Mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 570
Study Start Date: September 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: No Drains
Patients who will not receive intraperitoneal drainage following pancreas resection.
Procedure: No Drains
A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.
Experimental: Drains
Patients who will receive drains, the standard of care treatment, following pancreas resection.
Procedure: Drains
A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).
Other Name: The specific brand of drain is not contolled.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject has a surgical indication for distal pancreatectomy.
  • In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy.
  • At least 18 years of age.
  • The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group.
  • The subject is willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.

Exclusion Criteria:

  • The subject does not have a surgical indication for distal pancreatectomy.
  • In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy.
  • Less than 18 years of age.
  • The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group.
  • The subject is not willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.
  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: NCT01441492

Contacts
Contact: William E Fisher, MD 713-798-2262 wfisher@bcm.edu
Contact: Amy McElhany, MPH 713-798-1016 mcelhany@bcm.edu

Locations
United States, Florida
University of Florida Health Recruiting
Gainesville, Florida, United States, 32611
Contact: Amber Bouton    352-265-0761      
Principal Investigator: Steven Hughes, MD         
University of South Florida Terminated
Tampa, Florida, United States, 33606
United States, Indiana
Indiana University - Purdue University Indianapolis Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Leigh Mott    317-274-6748      
Principal Investigator: Nicholas Zyromski, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Marsha Ketcham, RN, OCN    402-559-5286      
Principal Investigator: Aaron Sasson, MD         
United States, New York
Winthrop-University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Barbara Moskowitz, ANP-C    516-663-2554      
Principal Investigator: John Allendorf, MD         
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Ericka Haverick, RN    614-366-3868      
Principal Investigator: Carl Schmidt, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jenna Gates    215-615-3259      
Principal Investigator: Charles Vollmer, MD         
Thomas Jefferson University Terminated
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29424
Contact: Cullen McWhite    843-792-2479      
Principal Investigator: Katherine Morgan, MD         
United States, Tennessee
University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38163
Contact: Vanessa Derrick    901-226-1689      
Principal Investigator: Stephen Behrman, MD         
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Heather Brien       hebrien@utmb.edu   
Principal Investigator: Kimberly Brown, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77338
Contact: William E Fisher, MD    832-798-2262      
Contact: Amy McElhany, MPH    713-798-1016      
Principal Investigator: William E Fisher, MD         
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Susan Isherwood, PhD    403-944-3649      
Principal Investigator: Chad Ball, MD         
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Jessica Saleh    416-480-6100      
Principal Investigator: Paul Karanicolas, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: William E Fisher, MD Baylor College of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: William E Fisher, Director, Elkins Pancreas Center, Professor, Michael E. DeBakey Department of Surgery, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01441492     History of Changes
Other Study ID Numbers: H-28324 
Study First Received: September 23, 2011
Last Updated: January 15, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Distal pancreatectomy
Pancreas resection

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Neoplasms
Pancreatic Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 21, 2016