Study Results
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View full resultsBasic Information
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COMPLETED
NA
399 participants
INTERVENTIONAL
2011-09-30
2017-07-25
Brief Summary
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Detailed Description
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Hypothesis:
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. The primary endpoint to assess the severity of complications will be the number of patients with any ≥ Grade II complication. Severity of complications experienced will also be assessed by comparing the number of patients with, any ≥ Grade III complication, any serious adverse event (SAE), and the median complication severity grade of all complications. The frequency of complications will be assessed by comparing the number of patients with 1, 2, 3, 4, 5, or more than 5 complications of any severity grade.
Objectives:
Primary: Difference in 60-day ≥ Grade II complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
Secondary:
A. 60-day ≥ Grade III complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
B. Serious adverse event (SAE) rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
C. Median complication severity grade comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
D. 60-day frequency of complications (any Grade) between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
E. 60-day, and 90-day mortality rate comparison between patients who receive a pancreatetomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
F. Rate of specific complications compared between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
G. Length of stay (index admission and total within 60 days) comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
H. Crude cost comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
I. Quality of life comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No Drains
Patients who will not receive intraperitoneal drainage following pancreas resection.
No Drains
A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.
Drains
Patients who will receive drains, the standard of care treatment, following pancreas resection.
Drains
A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).
Interventions
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No Drains
A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.
Drains
A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Baylor College of Medicine
OTHER
Responsible Party
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William E Fisher
Director, Elkins Pancreas Center, Professor, Michael E. DeBakey Department of Surgery
Principal Investigators
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William E Fisher, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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University of Florida Health
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States
Indiana University - Purdue University Indianapolis
Indianapolis, Indiana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Winthrop-University Hospital
Mineola, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Calgary
Calgary, Alberta, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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References
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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.
Van 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.
Related Links
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Elkins Pancreas Center
Other Identifiers
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H-28324
Identifier Type: -
Identifier Source: org_study_id
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