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

Phase 2

Terminated

• Conditions: 50 % Reduction of Delayed Gastric Emptying
• Interventions: Procedure: Conventional whipple procedure; Procedure: Subtotal gastrectomy as an adjunct to traditional whipple procedure.

• Registration Number: NCT02041052
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Whipple procedure	Conventional whipple procedure	Conventional Whipple procedure
Subtotal gastrectomy added to whipple procedure.	Subtotal gastrectomy as an adjunct to traditional whipple procedure.	Subtotal gastrectomy added to Whipple procedure.

Primary Outcome Measures

Name	Time	Method
Postoperative delayed gastric emptying	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

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

Trial Locations

Locations (1)

Karolinska University Hospital Gastrocentrum; 🇸🇪 Stockholm, Sweden