The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.

January 4, 2017 updated by: Lars Lundell, Karolinska University Hospital

Phase Two Randomized Study of The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.

A small gastric remnant after whipple resection improves gastric emptying and therefore prevents the development of delayed gastric emptying.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital Gastrocentrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Whipple procedure
Procedure: Conventional whipple procedure
All patients undergoing whipple procedure without risk for pancreaticojejunal anastomosis leakage.
Experimental: Subtotal gastrectomy added to whipple procedure.
Subtotal gastrectomy added to Whipple procedure.
Procedure: Subtotal gastrectomy as an adjunct to traditional whipple procedure.
Subtotal gastrectomy as an adjunct to traditional whipple procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative delayed gastric emptying
Time Frame: Postoperative recovery period in days (on an average <20 days)
During the postoperative phase the patient will be followed daily with assessment of symptoms suggestive of delayed gastric emptying.
Postoperative recovery period in days (on an average <20 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: during three first postoperative months
Quality of life measured by use of scientifically validated instruments.
during three first postoperative months
Postoperative hospital stay
Time Frame: In hospital stay in days (on an average <20 days)
Time in days from the operation to discharge from hospital.
In hospital stay in days (on an average <20 days)
Total Gastric emptying as measured by the paracetamol test
Time Frame: three months postoperatively
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.
three months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Ralf Segersvärd
Afshin Noorani
John Blomberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Estimate)

January 5, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/1262-31/3 (Other Identifier: Swedish Ethic Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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