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

Phase 3

• Conditions: Gastrectomy
• Interventions: Procedure: Billroth-I; Procedure: Roux en Y

• Registration Number: NCT01142271
• Lead Sponsor: Ajou University School of Medicine

Brief 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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-04
• Last Update Posted: 2011-11-06
• Primary Completion: 2012-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients diagnosed with adenocarcinoma at the endoscopic biopsy
• Patients who are possible to be performed curative resection in imaging study
• Patients with tumor which not involved in pylorus and are located in mid or distal portion of the stomach
• Patients with informed consent
• Patients with three or less American Society Anesthesiology Score 3

Exclusion Criteria

• Patients who are or become pregnant
• Patients with uncontrolled disease
• Patient s with synchronous other malignancy
• Patients participated in other clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Billroth-I	Billroth-I	Patients in this group should be underwent gastroduodenostomy as reconstruction procedure after standard distal subtotal gastrectomy with lymph node dissection.
Roux en Y	Roux en Y	Patients in this group should be underwent jejunojejunostomy and gastrojejunostomy as reconstruction procedure after standard distal gastrectomy.

Primary Outcome Measures

Name	Time	Method
Reflux of bile content	6 months after surgery	We estimate the degree of reflux by gastrofiberscopic findings using reflux score suggested by Romaganoli. In addition, histological finding of remnant stomach by endoscopic biopsy is also investigated. Reflux symptom is surveyed by Gastrointestinal Symptom Rating Scale.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	6 months after surgery	We investigate the quality of life with EORTC-C30, EORTC-STO22 questionnaire suggested by European Organization for Research and Treatment of Cancer (EORTC).
Morbidity	2 month after surgery	We investigate the occurrence of complication during recovery after surgery.
Anastomotic time	Day 1	We estimate anastomosis time
Nutritional state	6 month after surgery	We estimate Albumin, transferrin, lymphocyte, body weight
Mortality	2 month after operation	We investigate the occurrence of operation-related death during recovery after surgery.
Operation time	Day 1	We estimate total operation time.

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of