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

Karolinska University Hospital

Status and phase: Terminated; Phase 2

Conditions: 50 % Reduction of Delayed Gastric Emptying

Treatments: Procedure: Subtotal gastrectomy as an adjunct to traditional whipple procedure.; Procedure: Conventional whipple procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02041052

2011/1262-31/3 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 7 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

7 participants in 2 patient groups

Conventional Whipple procedure

Active Comparator group

Description:

Conventional Whipple procedure

Treatment:

Procedure: Conventional whipple procedure

Subtotal gastrectomy added to whipple procedure.

Experimental group

Description:

Subtotal gastrectomy added to Whipple procedure.

Treatment:

Procedure: Subtotal gastrectomy as an adjunct to traditional whipple procedure.