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

50 % Reduction of Delayed Gastric Emptying Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02041052
• Other study ID #: 2011/1262-31/3
• Secondary ID: 2011/1262-31/3
• Status: Terminated
• Phase: Phase 2
• First received: December 10, 2013
• Last updated: January 4, 2017
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2017
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish Research Council
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• 50 % Reduction of Delayed Gastric Emptying
• Gastroparesis

Intervention

Procedure:
• Subtotal gastrectomy as an adjunct to traditional whipple procedure.
Subtotal gastrectomy as an adjunct to traditional whipple procedure.
• Conventional whipple procedure
All patients undergoing whipple procedure without risk for pancreaticojejunal anastomosis leakage.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital Gastrocentrum	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska University Hospital	Afshin Noorani, John Blomberg, Ralf Segersvärd

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Quality of life	Quality of life measured by use of scientifically validated instruments.	during three first postoperative months	No
Secondary	Postoperative hospital stay	Time in days from the operation to discharge from hospital.	In hospital stay in days (on an average <20 days)	No
Secondary	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	No