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

Gastric Cancer Clinical Trial

Official title:

Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05344339
• Other study ID #: 15/GCN-HDDD
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: December 2023
• Source: University Medical Center Ho Chi Minh City (UMC)
• Contact: Long D. Vo, MD PhD
• Phone: +84918133915
• Email: long.vd[@]umc.edu.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: April 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Distal gastrectomy
Reconstruction after Distal Gastrectomy

Locations

Country	Name	City	State
Vietnam	University Medical Center Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Ho Chi Minh City (UMC)

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reflux esophagistis	Findings of reflux esophagitis according to Los Angeles classification via endoscopy	on the 12th month after surgery
Secondary	Early complications	Rate of any complications happened intraoperative and 30-days post-operative	30 days after surgery
Secondary	Operative time	Time from first incision to finishing abdomen closure, measured by surgical nurse	Intraoperative
Secondary	Time for making anastomosis	Time from jejunal stapler opening (for B-II) or from jejunal separating (for R-II) to finishing enhancing suture (including duodenal stump enhancement)	Intraoperative
Secondary	Blood loss	Weighing of sucked blood and gauze, minus weighing of dry gauze	Intraoperative
Secondary	Length of post-operative hospital stay	Number of days from date of surgery until date of discharge or mortality	30 days after surgery or until mortality
Secondary	Post gastrectomy syndromes	Rate of post gastrectomy syndromes after gastrectomy	from 30 days to 1 years after surgery
Secondary	Bodyweight	Changing of patient's weight at the follow-up time compare to weight before surgery	on the 3rd, 6th, and 12th month after surgery
Secondary	Serum total protein	Changing of patient's serum total protein at the follow-up time compare to serum protein before surgery	on the 3rd, 6th, and 12th month after surgery
Secondary	Serum albumin	Changing of patient's serum albumin at the follow-up time compare to serum albumin before surgery	on the 3rd, 6th, and 12th month after surgery
Secondary	Hemoglobin	Changing of patient's hemoglobin at the follow-up time compare to hemoglobin before surgery	on the 3rd, 6th, and 12th month after surgery
Secondary	Changing of Gastric remnant gastritis	Grade of gastric remnant gastritis according to RGB classification (for endoscopy) and updated Sydney classification (for histology)	on the 6th, and 12th month after surgery
Secondary	Changing of Residual food	Grade of Residual food according to RGB classification via endoscopy	on the 6th, and 12th month after surgery
Secondary	Changing of bile reflux	Finding of bile reflux according to RGB classification via endoscopy	on the 6th, and 12th month after surgery
Secondary	Changing of GSRS score	Patient's quality of life evaluated using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire	on the 3rd, 6th, and 12th month after surgery
Secondary	6th month reflux esophagistis	Findings of reflux esophagitis according to Los Angeles classification via endoscopy	on the 6th month after surgery