Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer

University Medical Center Ho Chi Minh City (UMC)

Status: Enrolling

Conditions: Gastric Cancer; Distal Gastrectomy

Treatments: Procedure: Distal gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05344339

15/GCN-HDDD

Details and patient eligibility

About

There are Billroth-I, Billroth-II, Billroth-II with Braun, and Roux-en-Y reconstruction after distal gastrectomy.

Hypothesis: Billroth-II modified method is non-inferior to Roux-en-Y method in terms of reducing reflux esophagitis after distal gastrectomy for gastric cancer patients.

Full description

Since the first gastrectomy by Theodore Billroth in 1881, this procedure remained a curative treatment for gastric cancer. Reconstruction method after gastrectomy may affect complication rates, post-operative nutritional status, and quality of life (QoL). There are several reconstruction methods for distal gastrectomy, including Billroth I (B-I), Billroth II (B-II), Roux-en-Y (R-Y). B-I and B-II were considered better than R-Y in terms of shorten operation time and lessen blood loss due to technical simplicity. In contrast, R-Y was better in terms of preventing bile reflux and remnant gastritis, which can increase remnant stomach cancer and worsen QoL. However, long term QoL was similar between B-I and R-Y in some randomized controlled trials. Although bile reflux was higher in B-I and B-II groups, remnant gastric cancer was similar between 3 groups in this study. In brief, which one is the ideal reconstruction after distal gastrectomy is still controversial.

At our center, reconstruction after distal and sub-total gastrectomy including B-I, B-II, B-II with Braun anastomosis, and R-Y, depended mostly on surgeons' preferences. From 2018, to decrease bile reflux rate while not increasing operation time, we applied modified B-II technique with 3-5 sutures between the afferent loop to the gastric remnant. This study was conducted to evaluate the efficacy of this method by comparing it with the R-Y method.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients confirmed with gastric cancer
• Indicated for radical distal gastrectomy (cT1 to cT4a, any N, M0; according to AJCC/UICC 8th TNM staging for gastric cancer)
• Age from 18- to 80-year-old
• Agreed to participate in study with written inform consent

Exclusion criteria

• Pregnant patients
• An American Society of Anesthesiology (ASA) score of higher than 4
• Concurrent cancer or history of previous other cancers
• Previous gastrectomy
• Complications including bleeding, perforation required emergency gastrectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Billroth-II modified

Experimental group

Description:

An opening will be made at jejunum 25 cm from Treitz's ligament. Another at greater curvature of the stomach right above transected line. A straight stapling device will be used to make isoperistaltic anastomosis at posterior wall of the stomach. After checking for bleeding, common entry hole will be closed using running suture and 3 -5 sutures to attach afferent loop to the remnant stomach

Treatment:

Procedure: Distal gastrectomy

Roux-en-Y

Active Comparator group

Description:

Jejunum will be transected 25 to 30 cm from Treitz's ligament. Marginal vessels will be transected if needed to make sure the loop will reach the stomach without tension. Isoperistaltic gastrojejunostomy will be made at posterior wall of the stomach. After checking for bleeding, common entry hole will be closed using running suture. Jejunojejunal mesenteric defect and Petersen's defect will be closed.

Treatment:

Procedure: Distal gastrectomy