Clinical Trials Directory

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UnknownNCT01142271

Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy

Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy for Gastric Cancer Patients : Prospective Randomized Study

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Ajou University School of Medicine · Academic / Other
Sex
All
Age
20 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer

Detailed description

Most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. However, the optimal reconstruction procedure after that has still not to be established. Although B-I reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. Roux en Y reconstruction may reduce the reflux to remnant stomach due to the length of Roux en Y limb, although it is more complicated procedure. Therefore, we plan to collect 120 patients to compare the degree of reflux between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer. In addition, we compare the surgical outcome and quality of life between two groups.

Conditions

Interventions

TypeNameDescription
PROCEDUREBillroth-IStandard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, gastroduodenostomy should be performed by circular stapler. In addition, stapler sites were re-enforced.
PROCEDURERoux en YStandard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, jejunojejunostomy and gastrojejunostomy should be performed by circular staplers. In addition, stapler sites were re-enforced.

Timeline

Start date
2010-06-01
Primary completion
2012-05-01
Completion
2012-05-01
First posted
2010-06-11
Last updated
2011-11-07

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01142271. Inclusion in this directory is not an endorsement.