Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer
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| ClinicalTrials.gov Identifier: NCT05344339 |
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Recruitment Status :
Recruiting
First Posted : April 25, 2022
Last Update Posted : January 3, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Cancer Distal Gastrectomy | Procedure: Distal gastrectomy | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 320 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Open label randomized control trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial |
| Actual Study Start Date : | October 8, 2022 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | April 30, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Billroth-II modified
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
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Procedure: Distal gastrectomy
Reconstruction after Distal Gastrectomy |
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Active Comparator: Roux-en-Y
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.
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Procedure: Distal gastrectomy
Reconstruction after Distal Gastrectomy |
- Reflux esophagistis [ Time Frame: on the 12th month after surgery ]Findings of reflux esophagitis according to Los Angeles classification via endoscopy
- Early complications [ Time Frame: 30 days after surgery ]Rate of any complications happened intraoperative and 30-days post-operative
- Operative time [ Time Frame: Intraoperative ]Time from first incision to finishing abdomen closure, measured by surgical nurse
- Time for making anastomosis [ Time Frame: Intraoperative ]Time from jejunal stapler opening (for B-II) or from jejunal separating (for R-II) to finishing enhancing suture (including duodenal stump enhancement)
- Blood loss [ Time Frame: Intraoperative ]Weighing of sucked blood and gauze, minus weighing of dry gauze
- Length of post-operative hospital stay [ Time Frame: 30 days after surgery or until mortality ]Number of days from date of surgery until date of discharge or mortality
- Post gastrectomy syndromes [ Time Frame: from 30 days to 1 years after surgery ]Rate of post gastrectomy syndromes after gastrectomy
- Bodyweight [ Time Frame: on the 3rd, 6th, and 12th month after surgery ]Changing of patient's weight at the follow-up time compare to weight before surgery
- Serum total protein [ Time Frame: on the 3rd, 6th, and 12th month after surgery ]Changing of patient's serum total protein at the follow-up time compare to serum protein before surgery
- Serum albumin [ Time Frame: on the 3rd, 6th, and 12th month after surgery ]Changing of patient's serum albumin at the follow-up time compare to serum albumin before surgery
- Hemoglobin [ Time Frame: on the 3rd, 6th, and 12th month after surgery ]Changing of patient's hemoglobin at the follow-up time compare to hemoglobin before surgery
- Changing of Gastric remnant gastritis [ Time Frame: on the 6th, and 12th month after surgery ]Grade of gastric remnant gastritis according to RGB classification (for endoscopy) and updated Sydney classification (for histology)
- Changing of Residual food [ Time Frame: on the 6th, and 12th month after surgery ]Grade of Residual food according to RGB classification via endoscopy
- Changing of bile reflux [ Time Frame: on the 6th, and 12th month after surgery ]Finding of bile reflux according to RGB classification via endoscopy
- Changing of GSRS score [ Time Frame: on the 3rd, 6th, and 12th month after surgery ]Patient's quality of life evaluated using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire
- 6th month reflux esophagistis [ Time Frame: on the 6th month after surgery ]Findings of reflux esophagitis according to Los Angeles classification via endoscopy
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05344339
| Contact: Long D. Vo, MD PhD | +84918133915 | long.vd@umc.edu.vn | |
| Contact: Thong Q. Dang, MD, MSc | +84333997861 | thong.dq@umc.edu.vn |
| Vietnam | |
| University Medical Center Ho Chi Minh City | Recruiting |
| Ho Chi Minh City, Vietnam, 700000 | |
| Contact: Long D. Vo, MD. +84918133915 long.vd@umc.edu.vn | |
| Contact: L D. | |
| Principal Investigator: | Long D Vo, MD, PhD | University Medical Center HCMC, VN |
| Responsible Party: | University Medical Center Ho Chi Minh City (UMC) |
| ClinicalTrials.gov Identifier: | NCT05344339 |
| Other Study ID Numbers: |
15/GCN-HDDD |
| First Posted: | April 25, 2022 Key Record Dates |
| Last Update Posted: | January 3, 2024 |
| Last Verified: | December 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Gastric Cancer Distal gastrectomy Reconstruction Gastric adenocarcinoma Roux-en-Y |
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Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |