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

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

Detailed Description
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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.

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

Conditions
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50 % Reduction of Delayed Gastric Emptying

Intervention / Treatment
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* Procedure: Subtotal gastrectomy as an adjunct to traditional whipple procedure.
* Procedure: Conventional whipple procedure


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delayed gastric emptying | 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 | Quality of life measured by use of scientifically validated instruments. | during three first postoperative months | 
| Postoperative hospital stay | 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 | 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 |