Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy

NCT ID: NCT03613142

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-12-30

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.

Conditions

Gastric Cancer; GastroEsophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Double tract anatomosis

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Esophagogastrostomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Biao Fan, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Ji, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Central Contacts

Xin Ji, M.D.

Role: CONTACT

18601201053@126.com

+86 18601201053

Other Identifiers

DTvsEG

Identifier Type: -

Identifier Source: org_study_id