Pancreas Resection With and Without Drains

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 1, 2014
Last verified: May 2014
  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 2015
Estimated Primary Completion Date: September 2015 (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
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, M.D. 832-355-1490 wfisher@bcm.edu
Contact: Courtney Nalty, M.S.P.H. 713-798-8441 courtney.nalty@bcm.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77338
Contact: William E Fisher, MD    832-355-1490      
Contact: Courtney Nalty    713-798-8441      
Principal Investigator: William E Fisher, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: William E Fisher, M.D. Baylor College of Medicine
  More Information

Additional Information:
No publications provided by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: May 1, 2014
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
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014