Distal Gastrectomy, Gastric Cancer
Conditions
Keywords
Gastric Cancer, Distal gastrectomy, Reconstruction, Gastric adenocarcinoma, Roux-en-Y
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.
Interventions
PROCEDUREDistal gastrectomy
Reconstruction after Distal Gastrectomy
Sponsors
University Medical Center Ho Chi Minh City (UMC)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reflux esophagistis | on the 12th month after surgery | Findings of reflux esophagitis according to Los Angeles classification via endoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Intraoperative | Time from first incision to finishing abdomen closure, measured by surgical nurse |
| Time for making anastomosis | 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 | Intraoperative | Weighing of sucked blood and gauze, minus weighing of dry gauze |
| Length of post-operative hospital stay | 30 days after surgery or until mortality | Number of days from date of surgery until date of discharge or mortality |
| Post gastrectomy syndromes | from 30 days to 1 years after surgery | Rate of post gastrectomy syndromes after gastrectomy |
| Bodyweight | 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 | 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 |
| Early complications | 30 days after surgery | Rate of any complications happened intraoperative and 30-days post-operative |
| Hemoglobin | 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 | 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 | on the 6th, and 12th month after surgery | Grade of Residual food according to RGB classification via endoscopy |
| Changing of bile reflux | on the 6th, and 12th month after surgery | Finding of bile reflux according to RGB classification via endoscopy |
| Changing of GSRS score | 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 | on the 6th month after surgery | Findings of reflux esophagitis according to Los Angeles classification via endoscopy |
| Serum albumin | 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 |
Countries
Vietnam
Contacts
Primary ContactLong D. Vo, MD PhD
Backup ContactThong Q. Dang, MD, MSc
Outcome results
None listed