Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Distal gastrectomy.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Distal Gastrectomy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial
Overview
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.
Interventions
- Procedure Distal gastrectomy
Reconstruction after Distal Gastrectomy
Primary outcome measures
- Reflux esophagistis [Time frame: on the 12th month after surgery]
Secondary outcome measures (12)
- Early complications [Time frame: 30 days after surgery]
- Operative time [Time frame: Intraoperative]
- Time for making anastomosis [Time frame: Intraoperative]
- Blood loss [Time frame: Intraoperative]
- Length of post-operative hospital stay [Time frame: 30 days after surgery or until mortality]
- Post gastrectomy syndromes [Time frame: from 30 days to 1 years after surgery]
- Bodyweight [Time frame: on the 3rd, 6th, and 12th month after surgery]
- Serum total protein [Time frame: on the 3rd, 6th, and 12th month after surgery]
- Serum albumin [Time frame: on the 3rd, 6th, and 12th month after surgery]
- Hemoglobin [Time frame: on the 3rd, 6th, and 12th month after surgery]
- Changing of Gastric remnant gastritis [Time frame: on the 6th, and 12th month after surgery]
- Changing of Residual food [Time frame: on the 6th, and 12th month after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Vietnam · 1 center
- University Medical Center Ho Chi Minh City — Ho Chi Minh City
Identifiers
NCT: NCT05344339 · 15/GCN-HDDD