Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Billroth-I | Standard 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. |
| PROCEDURE | Roux en Y | Standard 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.