University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000, Vietnam
Location status: Recruiting
NCT Number: NCT05344339
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Ho Chi Minh City, 700000, Vietnam
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Reconstruction after Distal Gastrectomy
Time frame: on the 12th month after surgery
Findings of reflux esophagitis according to Los Angeles classification via endoscopy
Time frame: 30 days after surgery
Rate of any complications happened intraoperative and 30-days post-operative
Time frame: Intraoperative
Time from first incision to finishing abdomen closure, measured by surgical nurse
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)
Time frame: Intraoperative
Weighing of sucked blood and gauze, minus weighing of dry gauze
Time frame: 30 days after surgery or until mortality
Number of days from date of surgery until date of discharge or mortality
Time frame: from 30 days to 1 years after surgery
Rate of post gastrectomy syndromes after gastrectomy
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
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
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
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
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)
Time frame: on the 6th, and 12th month after surgery
Grade of Residual food according to RGB classification via endoscopy
Time frame: on the 6th, and 12th month after surgery
Finding of bile reflux according to RGB classification via endoscopy
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
Time frame: on the 6th month after surgery
Findings of reflux esophagitis according to Los Angeles classification via endoscopy
Contact information is provided by the study sponsor or research team.
Long D. Vo, MD PhD
CONTACT
Thong Q. Dang, MD, MSc
CONTACT
University Medical Center Ho Chi Minh City (UMC)
Other
Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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