Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy

NCT03613142 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2018-11-08

No results posted yet for this study

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

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Xin Ji, M.D. · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-12-30
Completion
2021-12-30

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03613142 on ClinicalTrials.gov