Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
There are Billroth-I, Billroth-II, Billroth-II with Braun, and Roux-en-Y reconstruction after distal gastrectomy. Hypothesis: Billroth-II modified method is non-inferior to Roux-en-Y method in terms of reducing reflux esophagitis after distal gastrectomy for gastric cancer patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Patients confirmed with gastric cancer
• Indicated for radical distal gastrectomy (cT1 to cT4a, any N, M0; according to AJCC/UICC 8th TNM staging for gastric cancer)
• Age from 18- to 80-year-old
• Agreed to participate in study with written inform consent
Locations
Other Locations
Viet Nam
University Medical Center Ho Chi Minh City
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Long D. Vo, MD PhD
long.vd@umc.edu.vn
+84918133915
Backup
Thong Q. Dang, MD, MSc
thong.dq@umc.edu.vn
+84333997861
Time Frame
Start Date: 2022-10-08
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 320
Treatments
Experimental: Billroth-II modified
An opening will be made at jejunum 25 cm from Treitz's ligament. Another at greater curvature of the stomach right above transected line. A straight stapling device will be used to make isoperistaltic anastomosis at posterior wall of the stomach. After checking for bleeding, common entry hole will be closed using running suture and 3 -5 sutures to attach afferent loop to the remnant stomach
Active_comparator: Roux-en-Y
Jejunum will be transected 25 to 30 cm from Treitz's ligament. Marginal vessels will be transected if needed to make sure the loop will reach the stomach without tension. Isoperistaltic gastrojejunostomy will be made at posterior wall of the stomach. After checking for bleeding, common entry hole will be closed using running suture. Jejunojejunal mesenteric defect and Petersen's defect will be closed.
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Ho Chi Minh City (UMC)