Back to resultsThe Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.
Primary Purpose
50 % Reduction of Delayed Gastric Emptying
Status
Terminated
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Subtotal gastrectomy as an adjunct to traditional whipple procedure.
Conventional whipple procedure
Sponsored by
About this trial
This is an interventional treatment trial for 50 % Reduction of Delayed Gastric Emptying
Eligibility Criteria
Inclusion Criteria:
All patients undergoing whipple procedure with preoperative assignment as low risk for leakage from the pancreaticojejunal anastomosis.
- Signed informed consent.
Exclusion Criteria:
- High and intermediate risk pancreaticojejunal anastomosis. Unwillingness to participate.
Sites / Locations
- Karolinska University Hospital Gastrocentrum
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Whipple procedure
Subtotal gastrectomy added to whipple procedure.
Arm Description
Conventional Whipple procedure
Subtotal gastrectomy added to Whipple procedure.
Outcomes
Primary Outcome Measures
Postoperative delayed gastric emptying
During the postoperative phase the patient will be followed daily with assessment of symptoms suggestive of delayed gastric emptying.
Secondary Outcome Measures
Quality of life
Quality of life measured by use of scientifically validated instruments.
Postoperative hospital stay
Time in days from the operation to discharge from hospital.
Total Gastric emptying as measured by the paracetamol test
Paracetamol orally ingested together with chocolate biscuits whereafter peripheral venous blood concentrations of paracetamol are determined. Blood samples taken at baseline and every 15 minutes after paracetamol ingestion during the first hour and then every 30 minutes for an hour.
Full Information
NCT ID
NCT02041052
First Posted
December 10, 2013
Last Updated
January 4, 2017
Sponsor
Karolinska University Hospital
Collaborators
Ralf Segersvärd, Afshin Noorani, John Blomberg
1. Study Identification
Unique Protocol Identification Number
NCT02041052
Brief Title
The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.
Official Title
Phase Two Randomized Study of The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to insufficient inclusion rate.
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Ralf Segersvärd, Afshin Noorani, John Blomberg
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A small gastric remnant after whipple resection improves gastric emptying and therefore prevents the development of delayed gastric emptying.
Detailed Description
Every patient submitted to a whipple resection and at the same time present with characteristics suggestive of minimal risk for leakage from the pancreaticojejunostomy will be included in the study. At the time of reconstruction the patient will be randomized to either conventional size of the stomach or to a subtotal gastrectomy containing a small upper gastric pouch only.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
50 % Reduction of Delayed Gastric Emptying
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Whipple procedure
Arm Type
Active Comparator
Arm Description
Conventional Whipple procedure
Arm Title
Subtotal gastrectomy added to whipple procedure.
Arm Type
Experimental
Arm Description
Subtotal gastrectomy added to Whipple procedure.
Intervention Type
Procedure
Intervention Name(s)
Subtotal gastrectomy as an adjunct to traditional whipple procedure.
Intervention Description
Subtotal gastrectomy as an adjunct to traditional whipple procedure.
Intervention Type
Procedure
Intervention Name(s)
Conventional whipple procedure
Intervention Description
All patients undergoing whipple procedure without risk for pancreaticojejunal anastomosis leakage.
Primary Outcome Measure Information:
Title
Postoperative delayed gastric emptying
Description
During the postoperative phase the patient will be followed daily with assessment of symptoms suggestive of delayed gastric emptying.
Time Frame
Postoperative recovery period in days (on an average <20 days)
Secondary Outcome Measure Information:
Title
Quality of life
Description
Quality of life measured by use of scientifically validated instruments.
Time Frame
during three first postoperative months
Title
Postoperative hospital stay
Description
Time in days from the operation to discharge from hospital.
Time Frame
In hospital stay in days (on an average <20 days)
Title
Total Gastric emptying as measured by the paracetamol test
Description
Paracetamol orally ingested together with chocolate biscuits whereafter peripheral venous blood concentrations of paracetamol are determined. Blood samples taken at baseline and every 15 minutes after paracetamol ingestion during the first hour and then every 30 minutes for an hour.
Time Frame
three months postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients undergoing whipple procedure with preoperative assignment as low risk for leakage from the pancreaticojejunal anastomosis.
Signed informed consent.
Exclusion Criteria:
High and intermediate risk pancreaticojejunal anastomosis. Unwillingness to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Lundell, professor
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital Gastrocentrum
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.
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