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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-12-31

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.

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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.

Conditions

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50 % Reduction of Delayed Gastric Emptying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional Whipple procedure

Group Type ACTIVE_COMPARATOR

Conventional whipple procedure

Intervention Type PROCEDURE

All patients undergoing whipple procedure without risk for pancreaticojejunal anastomosis leakage.

Subtotal gastrectomy added to whipple procedure.

Subtotal gastrectomy added to Whipple procedure.

Group Type EXPERIMENTAL

Subtotal gastrectomy as an adjunct to traditional whipple procedure.

Intervention Type PROCEDURE

Subtotal gastrectomy as an adjunct to traditional whipple procedure.

Interventions

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Subtotal gastrectomy as an adjunct to traditional whipple procedure.

Intervention Type PROCEDURE

Conventional whipple procedure

All patients undergoing whipple procedure without risk for pancreaticojejunal anastomosis leakage.

Intervention Type PROCEDURE

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.