ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02041052
Recruitment Status : Terminated (Terminated due to insufficient inclusion rate.)
First Posted : January 20, 2014
Last Update Posted : January 5, 2017
Sponsor:
Collaborators:
Ralf Segersvärd
Afshin Noorani
John Blomberg
Information provided by (Responsible Party):
Lars Lundell, Karolinska University Hospital

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

Condition or disease Intervention/treatment Phase
50 % Reduction of Delayed Gastric Emptying Procedure: Subtotal gastrectomy as an adjunct to traditional whipple procedure. Procedure: Conventional whipple procedure Phase 2

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  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase Two Randomized Study of The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Conventional Whipple procedure
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: during three first postoperative months ]
    Quality of life measured by use of scientifically validated instruments.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02041052


Locations
Sweden
Karolinska University Hospital Gastrocentrum
Stockholm, Sweden
Sponsors and Collaborators
Karolinska University Hospital
Ralf Segersvärd
Afshin Noorani
John Blomberg
Investigators
Principal Investigator: Lars Lundell, professor Karolinska University Hospital

Responsible Party: Lars Lundell, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02041052     History of Changes
Other Study ID Numbers: 2011/1262-31/3
2011/1262-31/3 ( Other Identifier: Swedish Ethic Committee )
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms