The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.
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|ClinicalTrials.gov Identifier: NCT02041052|
Recruitment Status : Terminated (Terminated due to insufficient inclusion rate.)
First Posted : January 20, 2014
Last Update Posted : January 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|50 % Reduction of Delayed Gastric Emptying||Procedure: Subtotal gastrectomy as an adjunct to traditional whipple procedure. Procedure: Conventional whipple procedure||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase Two Randomized Study of The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.|
|Study Start Date :||January 2013|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
Active Comparator: Conventional Whipple procedure
Conventional Whipple procedure
Procedure: Conventional whipple procedure
All patients undergoing whipple procedure without risk for pancreaticojejunal anastomosis leakage.
Experimental: Subtotal gastrectomy added to whipple procedure.
Subtotal gastrectomy added to Whipple procedure.
Procedure: Subtotal gastrectomy as an adjunct to traditional whipple procedure.
Subtotal gastrectomy as an adjunct to traditional whipple procedure.
- Postoperative delayed gastric emptying [ Time Frame: 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.
- Quality of life [ Time Frame: during three first postoperative months ]Quality of life measured by use of scientifically validated instruments.
- Postoperative hospital stay [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041052
|Karolinska University Hospital Gastrocentrum|
|Principal Investigator:||Lars Lundell, professor||Karolinska University Hospital|