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Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy

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ClinicalTrials.gov Identifier: NCT02343302
Recruitment Status : Suspended (IRB application expired- new application is in process)
First Posted : January 21, 2015
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
A very common complication following distal pancreatectomy is leakage from the pancreas, or what is called a pancreatic fistula. We hypothesize that operative drains which create suction may contribute to the development of leakage from the pancreas. This study evaluates the effect of using non-suctioning drains to prevent the development of this complication.

Condition or disease Intervention/treatment Phase
Pancreatic Fistula Device: Jackson-Pratt Drain Device: Non-suctioning drainage Not Applicable

Detailed Description:
The most common complication following distal pancreatectomy is the developement of leakage from the remaining pancreas gland, which results in significant morbidity. Most surgeons leave dains at the time of surgery to prevent complications from pancreatic leakage. However, we hypothesize that drains which create continous negative pressure may contribute to the development of a pancreatic fistula. This study randomizes patients to suctioning versus non-suctioning drains. The primary endpoint is the development of pancreatic fistuale, as defined by the International Study Group of Pancreatic Surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy
Actual Study Start Date : February 2013
Estimated Primary Completion Date : January 13, 2021
Estimated Study Completion Date : April 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Soft Pancreatic Gland
This arm will be patients with glands felt to have a soft texture during surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.
Device: Jackson-Pratt Drain
A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "suction drain"

Device: Non-suctioning drainage
A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "gravity drain"

Hard Pancreatic Gland
This arm will include patients felt to have a hard gland tecture at the time of surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.
Device: Jackson-Pratt Drain
A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "suction drain"

Device: Non-suctioning drainage
A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "gravity drain"




Primary Outcome Measures :
  1. Post-operative Pancreatic Fistula [ Time Frame: 90 days ]
    The primary endpoint of the study is the developement of post-operative pancreatic fistula, as defined by the International Study Group of Pancreatic Surgery.


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 90 days ]
    All morbidity, including length of hospital stay, need for enteral/parenteral nutrition, need for radiologic/surgical intervention, septic complications, and peri-operative mortality.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing distal pancreatectomy at Johns Hopkins Hospital

Exclusion Criteria:

  • Children <18 years old, pregnant women, adults lacking capacity to consent, non-english speakers, and prisoners.

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): NCT02343302


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Matthew J Weiss, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02343302     History of Changes
Other Study ID Numbers: NA_00080937
IRB00197557 ( Other Identifier: Johns Hopkins IRB )
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Keywords provided by Johns Hopkins University:
Pancreatic Fistula

Additional relevant MeSH terms:
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Pancreatic Fistula
Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases