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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastrectomy

Intervention / Treatment
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* Procedure: Billroth-I
* Procedure: Roux en Y


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Billroth-I<br>Patients in this group should be underwent gastroduodenostomy as reconstruction procedure after standard distal subtotal gastrectomy with lymph node dissection. | Procedure: Billroth-I<br>* 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.<br>* Other names: Gastroduodenostomy;|
| Experimental: Roux en Y<br>Patients in this group should be underwent jejunojejunostomy and gastrojejunostomy as reconstruction procedure after standard distal gastrectomy. | Procedure: Roux en Y<br>* 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.<br>* Other names: Gastrojejunostomy and jejunojejunostomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux of bile content | 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. | 6 months after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal gastrectomy, Reconstruction, Reflux, subtotal gastrectomy