Clinical trial NCT05344339: Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer
Official title: Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Distal Gastrectomy
Keywords: Gastric Cancer
Distal gastrectomy
Reconstruction
Gastric adenocarcinoma
Roux-en-Y
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomized control trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reflux esophagistis
timeFrame: on the 12th month after surgery
Secondary outcomes:
measure: Early complications
timeFrame: 30 days after surgery
measure: Operative time
timeFrame: Intraoperative
measure: Time for making anastomosis
timeFrame: Intraoperative
measure: Blood loss
timeFrame: Intraoperative
measure: Length of post-operative hospital stay
timeFrame: 30 days after surgery or until mortality
measure: Post gastrectomy syndromes
timeFrame: from 30 days to 1 years after surgery
measure: Bodyweight
timeFrame: on the 3rd, 6th, and 12th month after surgery
measure: Serum total protein
timeFrame: on the 3rd, 6th, and 12th month after surgery
measure: Serum albumin
timeFrame: on the 3rd, 6th, and 12th month after surgery
measure: Hemoglobin
timeFrame: on the 3rd, 6th, and 12th month after surgery
measure: Changing of Gastric remnant gastritis
timeFrame: on the 6th, and 12th month after surgery
measure: Changing of Residual food
timeFrame: on the 6th, and 12th month after surgery
measure: Changing of bile reflux
timeFrame: on the 6th, and 12th month after surgery
measure: Changing of GSRS score
timeFrame: on the 3rd, 6th, and 12th month after surgery
measure: 6th month reflux esophagistis
timeFrame: on the 6th month after surgery
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center Ho Chi Minh City
Study officials:
affiliation: University Medical Center HCMC, VN
name: Long D Vo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: