Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy
Primary Purpose
Pancreatic Fistula
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Jackson-Pratt Drain
Non-suctioning drainage
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Fistula focused on measuring Pancreatic Fistula
Eligibility 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.
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Soft Pancreatic Gland
Hard Pancreatic Gland
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Post-operative Pancreatic Fistula
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
Morbidity
All morbidity, including length of hospital stay, need for enteral/parenteral nutrition, need for radiologic/surgical intervention, septic complications, and peri-operative mortality.
Full Information
NCT ID
NCT02343302
First Posted
January 15, 2015
Last Updated
November 22, 2021
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT02343302
Brief Title
Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy
Official Title
Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Poor patient accrual
Study Start Date
February 2013 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Fistula
Keywords
Pancreatic Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Soft Pancreatic Gland
Arm Type
Other
Arm Description
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.
Arm Title
Hard Pancreatic Gland
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Jackson-Pratt Drain
Intervention Description
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"
Intervention Type
Device
Intervention Name(s)
Non-suctioning drainage
Intervention Description
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 Measure Information:
Title
Post-operative Pancreatic Fistula
Description
The primary endpoint of the study is the developement of post-operative pancreatic fistula, as defined by the International Study Group of Pancreatic Surgery.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Morbidity
Description
All morbidity, including length of hospital stay, need for enteral/parenteral nutrition, need for radiologic/surgical intervention, septic complications, and peri-operative mortality.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher L Wolfgang, MD PHD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy
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