Pancreas Resection With and Without Drains
A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage
1 other identifier
interventional
399
2 countries
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
September 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2017
CompletedResults Posted
Study results publicly available
August 31, 2020
CompletedAugust 31, 2020
August 1, 2020
5 years
September 23, 2011
August 8, 2018
August 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
60-day ≥ Grade II Complication Rate
The primary outcome measure was defined as the number of patients with grade 2 or higher grade complications within 60 days of the date of surgery will be meticulously recorded using specific and standardized definitions. Complications will be graded in severity using the Common Terminology Criteria for Adverse Events CTCAE (v4.0) (Grade 1-5) unless otherwise stated below. For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.
60 days
Secondary Outcomes (9)
60-day ≥ Grade III Complication Rate
60 days
Serious Adverse Event (SAE) Rate
60 days
Median Complication Severity Grade
60 days
60-day Frequency of Complications
60 days
90-day Mortality Rate
90 days
- +4 more secondary outcomes
Study Arms (2)
No Drains
EXPERIMENTALPatients who will not receive intraperitoneal drainage following pancreas resection.
Drains
EXPERIMENTALPatients who will receive drains, the standard of care treatment, following pancreas resection.
Interventions
A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.
A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University of Florida Health
Gainesville, Florida, 32611, United States
University of South Florida
Tampa, Florida, 33606, United States
Indiana University - Purdue University Indianapolis
Indianapolis, Indiana, 46202, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Winthrop-University Hospital
Mineola, New York, 11501, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston, South Carolina, 29424, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Baylor College of Medicine
Houston, Texas, 77338, United States
University of Calgary
Calgary, Alberta, T2N 1N4, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Related Publications (2)
Fisher WE, Hodges SE, Silberfein EJ, Artinyan A, Ahern CH, Jo E, Brunicardi FC. Pancreatic resection without routine intraperitoneal drainage. HPB (Oxford). 2011 Jul;13(7):503-10. doi: 10.1111/j.1477-2574.2011.00331.x.
PMID: 21689234BACKGROUNDVan Buren G 2nd, Bloomston M, Hughes SJ, Winter J, Behrman SW, Zyromski NJ, Vollmer C, Velanovich V, Riall T, Muscarella P, Trevino J, Nakeeb A, Schmidt CM, Behrns K, Ellison EC, Barakat O, Perry KA, Drebin J, House M, Abdel-Misih S, Silberfein EJ, Goldin S, Brown K, Mohammed S, Hodges SE, McElhany A, Issazadeh M, Jo E, Mo Q, Fisher WE. A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage. Ann Surg. 2014 Apr;259(4):605-12. doi: 10.1097/SLA.0000000000000460.
PMID: 24374513BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A potential weakness of the current study is that it took 5 years to reach targeted accrual.
Results Point of Contact
- Title
- Amy McElhany, Clinical Research Manager
- Organization
- Baylor College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
William E Fisher, MD
Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Elkins Pancreas Center, Professor, Michael E. DeBakey Department of Surgery
Study Record Dates
First Submitted
September 23, 2011
First Posted
September 27, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2016
Study Completion
July 25, 2017
Last Updated
August 31, 2020
Results First Posted
August 31, 2020
Record last verified: 2020-08