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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02041052

Enrollment

Registered

2014-01-20

Start date

2013-01-31

Completion date

2014-12-31

Last updated

2017-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

50 % Reduction of Delayed Gastric Emptying

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.

Interventions

PROCEDURESubtotal gastrectomy as an adjunct to traditional whipple procedure.

Subtotal gastrectomy as an adjunct to traditional whipple procedure.

PROCEDUREConventional whipple procedure

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026