Status:
UNKNOWN
Incidence of Duodenal Stump Fistula After Gastrectomy for Gastric Cancer. A Randomized Controlled Trial
Lead Sponsor:
University of Turin, Italy
Conditions:
Gastric Cancer
Duodenal Stump Leak
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The goal of this trial is to demonstrate that the use of Tri-Staple Technology for duodenal resection during open gastrectomy for cancer is safer than the use of other conventional methods of resectio...
Detailed Description
BACKGROUND Gastric cancer is still one of the most frequent malignancies in Europe. In United States the estimated new cases in 2010 were 21000 (12730 male and 8270 female) with 10570 estimated deaths...
Eligibility Criteria
Inclusion
- pathologically proven malign tumor of the stomach
- age of 18 to 80 years,
- no history of other cancers
- no history of radiotherapy in supra-mesocolic space
- total or distal gastrectomy without anastomosis with the duodenum
Exclusion
- emergency surgery
- American Society of Anesthesiologists class \> 3
- need for combined resection of other organs
- laparoscopic/robotic access
- severe heart disease
- liver cirrhosis
- T stage \>cT4a
- citology positive at preoperative laparoscopy
- cM+ (clinical suspicion of distant metastasis)
- cD+ (clinical suspicion of duodenal involvment)
Key Trial Info
Start Date :
September 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT03277144
Start Date
September 11 2017
End Date
October 1 2019
Last Update
September 18 2017
Active Locations (1)
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1
San Luigi University Hospital
Orbassano, Turin, Italy