Double Tract Anastomosis and Gastric Tube Anastomosis to Proximal Gastrectomy — DTA&GTA  

Quality of Life Clinical Trial

Official title: Remnant Stomach-jejunum Double Tract Anastomosis vs. Gastric Tube Anastomosis to Proximal Gastrectomy of Early Gastric Cancer- a Randomized Controlled Trial

Status Terminated

Clinical Trial Summary

Gastric cancer as one of the most common gastrointestinal cancers, radical resection of primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. When compared with the advanced upper third gastric cancer, proximal gastrectomy has been acknowledged as the standard therapeutic strategy for the early gastric cancer located in the upper third of the stomach. However, due to abandon the anti-reflux barrier of the digestive system caused by the dissection of the cardia and the lower esophageal sphincter, the belching、hiccup、Acid reflux、heartburn、chest pain symptoms and as well as the reflux esophagitis caused by the traditional esophagostomy permanently influence the postoperative quality of life for those patients. Nowadays, relationship between the digestive track reconstruction for proximal gastrectomy and the postoperative quality of life is still with controversies. Previous study reported the gastric tube anastomosis can minimize the reflux related symptoms when compared with traditional esophagogastrostomy. There still exited some patients need long-term anti-acid drug to control the reflux symptoms although underwent the gastric tube anastomosis. The double-track anastomosis for proximal gastrectomy may successfully control the reflux symptoms and there existed study found it is as safe as the esophagostomy. But there has no randomized control study to compare the postoperative quality of life between the gastric tube anastomosis and double-track anastomosis for proximal gastrectomy.

By the reasons above, a randomized controlled trial is conducted with the intention to compare the intraoperative and postoperative mortality and morbidity and the postoperative quality of life between the esophagogastrostomy and the double-track anastomosis in the proximal gastrectomy for gastric cancer patients.

Clinical Trial Description

Standard Operating Procedure (SOP)

1. Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.

2. Randomization: Intraoperative evaluation found that R0, proximal gastrectomy can be performed, the case will entrance into the Randomization period. Random numbers are computer-generated, with the third party applications.

3. Surgical procedures: The surgical treatments is adopted the proximal gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3. Group A take the gastric tube anastomosis and Group B take the double-track anastomosis (the reconstruction method is described in the intervention section of study groups). The two study will take the similar surgical procedures except for the digestive track reconstruction.

4. Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.

5. Follow-up: The follow-up of this study divide into two parts, the postoperative quality of life and tumor characteristics outcomes. The information of the postoperative quality of life is collected by the European Organization for Research and Treatment of Cancer (EORCT) QLQ-C30 and STO-22 questionnaires. At the postoperative 12 moths, the upper gastrointestinal scope is needed to examine the reflux esophagitis and the remnant gastritis according to Los Angeles Classification of esophagitis. The tumor related outcomes included long-term postoperative complications, recurrence type, relapse free survival (months) and the overall survival (months). ;

Related Conditions & MeSH terms

• Complications
• Esophagitis
• Esophagitis, Peptic
• Gastritis
• Quality of Life
• Reflux Esophagitis
• Remnant Gastritis

• NCT number: NCT02288728
• Study type: Interventional
• Source: West China Hospital
• Status: Terminated
• Phase: N/A
• Start date: December 2014
• Completion date: December 2017