Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy

Peking University Cancer Hospital & Institute

Status: Unknown

Conditions: Gastric Cancer; GastroEsophageal Cancer

Treatments: Procedure: Esophagogastrostomy; Procedure: Double tract anatomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT03613142

DTvsEG

Details and patient eligibility

About

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.

Enrollment: 202 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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202 participants in 2 patient groups

Double tract anatomosis

Experimental group

Description:

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.

Treatment:

Procedure: Double tract anatomosis

Esophagogastrostomy

Active Comparator group

Description:

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.

Treatment:

Procedure: Esophagogastrostomy