Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy

Not Applicable

• Conditions: Gastric Cancer; GastroEsophageal Cancer
• Interventions: Procedure: Double tract anatomosis; Procedure: Esophagogastrostomy

• Registration Number: NCT03613142
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

The patients with upper gastric cancer (cT1N0M0) or gastroesophageal adenocarcinoma (diameter less than 4 cm) will be enrolled into this study. Each of these patients will undergo radical proximal gastrectomy and be randomly allocated into one of the two groups, double tract anastomosis group or esophagogastrostomy group. The following data will be collected to compare the difference between the two reconstruction methods: the rate of reflux esophagitis, postoperative quality of life, economic expenditure, the safety of operation, postoperative recovery, postoperative nutrition status and oncological effect. Through the comprehensive analysis, the result of this study will elucidate the best of the reconstruction method after proximal gastrectomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-02
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-07
• Last Update Posted: 2018-11-08
• Study Start: 2019-01-01
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

1. Patients diagnosed as gastric or esophagogastric adenocarcinoma
2. Age ranges from 18 to 80
3. Karnofsky assessment no less than 70
4. Completion of abdominal CT scan and ultrasound endoscopy
5. Upper gastric cancer (cT1N0M0) or esophagogastric adenocarcinoma (diameter no more than 4 cm)
6. radical proximal gastrectomy
7. Normal blood routine examination and biochemical test

Exclusion Criteria

1. Patients need to undergo total gastrectomy or distal gastrectomy
2. Female patients with pregnancy
3. Not suitable for operation
4. Patients have already joined other clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Double tract anatomosis	Double tract anatomosis	After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers.
Esophagogastrostomy	Esophagogastrostomy	After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler.

Primary Outcome Measures

Name	Time	Method
Rate of reflux esophagitis after operation	12 months	The rate of reflux esophagitis after operation will be assessed by gastrointestinal endoscopy with Los Angeles (LA) classification. the degree of reflux esophagitis will be classified as N, A, B, C or D level, and latter levels represent a more severe reflux esophagitis.

Secondary Outcome Measures

Name	Time	Method
postoperative quality of life	12months	Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - STO22 questionnaire, the total score ranges from 22 to 88, and higher values represent a worse outcome.