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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Ralf Segersvärd
Afshin Noorani
John Blomberg
Information provided by (Responsible Party):
Lars Lundell, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT02041052
First received: December 10, 2013
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Postoperative delayed gastric emptying [ Time Frame: Postoperative recovery period in days (on an average <20 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: during three first postoperative months ] [ Designated as safety issue: No ]
    Quality of life measured by use of scientifically validated instruments.

  • Postoperative hospital stay [ Time Frame: In hospital stay in days (on an average <20 days) ] [ Designated as safety issue: No ]
    Time in days from the operation to discharge from hospital.

  • Total Gastric emptying as measured by the paracetamol test [ Time Frame: three months postoperatively ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 10, 2013
Last Updated: January 17, 2014
Health Authority: Sweden: Swedish Research Council

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

ClinicalTrials.gov processed this record on September 15, 2014