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Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer

Primary Purpose

Gastric Cancer, Distal Gastrectomy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Distal gastrectomy
Sponsored by
University Medical Center Ho Chi Minh City (UMC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Distal gastrectomy, Reconstruction, Gastric adenocarcinoma, Roux-en-Y

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center Ho Chi Minh City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Billroth-II modified

Roux-en-Y

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Reflux esophagistis
Findings of reflux esophagitis according to Los Angeles classification via endoscopy

Secondary Outcome Measures

Early complications
Rate of any complications happened intraoperative and 30-days post-operative
Operative time
Time from first incision to finishing abdomen closure, measured by surgical nurse
Time for making anastomosis
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
Weighing of sucked blood and gauze, minus weighing of dry gauze
Length of post-operative hospital stay
Number of days from date of surgery until date of discharge or mortality
Post gastrectomy syndromes
Rate of post gastrectomy syndromes after gastrectomy
Bodyweight
Changing of patient's weight at the follow-up time compare to weight before surgery
Serum total protein
Changing of patient's serum total protein at the follow-up time compare to serum protein before surgery
Serum albumin
Changing of patient's serum albumin at the follow-up time compare to serum albumin before surgery
Hemoglobin
Changing of patient's hemoglobin at the follow-up time compare to hemoglobin before surgery
Changing of Gastric remnant gastritis
Grade of gastric remnant gastritis according to RGB classification (for endoscopy) and updated Sydney classification (for histology)
Changing of Residual food
Grade of Residual food according to RGB classification via endoscopy
Changing of bile reflux
Finding of bile reflux according to RGB classification via endoscopy
Changing of GSRS score
Patient's quality of life evaluated using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire
6th month reflux esophagistis
Findings of reflux esophagitis according to Los Angeles classification via endoscopy

Full Information

First Posted
April 8, 2022
Last Updated
August 3, 2022
Sponsor
University Medical Center Ho Chi Minh City (UMC)
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1. Study Identification

Unique Protocol Identification Number
NCT05344339
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 8, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Ho Chi Minh City (UMC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Distal Gastrectomy
Keywords
Gastric Cancer, Distal gastrectomy, Reconstruction, Gastric adenocarcinoma, Roux-en-Y

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open label randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Billroth-II modified
Arm Type
Experimental
Arm Description
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
Arm Title
Roux-en-Y
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Distal gastrectomy
Intervention Description
Reconstruction after Distal Gastrectomy
Primary Outcome Measure Information:
Title
Reflux esophagistis
Description
Findings of reflux esophagitis according to Los Angeles classification via endoscopy
Time Frame
on the 12th month after surgery
Secondary Outcome Measure Information:
Title
Early complications
Description
Rate of any complications happened intraoperative and 30-days post-operative
Time Frame
30 days after surgery
Title
Operative time
Description
Time from first incision to finishing abdomen closure, measured by surgical nurse
Time Frame
Intraoperative
Title
Time for making anastomosis
Description
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
Title
Blood loss
Description
Weighing of sucked blood and gauze, minus weighing of dry gauze
Time Frame
Intraoperative
Title
Length of post-operative hospital stay
Description
Number of days from date of surgery until date of discharge or mortality
Time Frame
30 days after surgery or until mortality
Title
Post gastrectomy syndromes
Description
Rate of post gastrectomy syndromes after gastrectomy
Time Frame
from 30 days to 1 years after surgery
Title
Bodyweight
Description
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
Title
Serum total protein
Description
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
Title
Serum albumin
Description
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
Title
Hemoglobin
Description
Changing of patient's hemoglobin at the follow-up time compare to hemoglobin before surgery
Time Frame
on the 3rd, 6th, and 12th month after surgery
Title
Changing of Gastric remnant gastritis
Description
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
Title
Changing of Residual food
Description
Grade of Residual food according to RGB classification via endoscopy
Time Frame
on the 6th, and 12th month after surgery
Title
Changing of bile reflux
Description
Finding of bile reflux according to RGB classification via endoscopy
Time Frame
on the 6th, and 12th month after surgery
Title
Changing of GSRS score
Description
Patient's quality of life evaluated using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire
Time Frame
on the 3rd, 6th, and 12th month after surgery
Title
6th month reflux esophagistis
Description
Findings of reflux esophagitis according to Los Angeles classification via endoscopy
Time Frame
on the 6th month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Long D. Vo, MD PhD
Phone
+84918133915
Email
long.vd@umc.edu.vn
First Name & Middle Initial & Last Name or Official Title & Degree
Thong Q. Dang, MD, MSc
Phone
+84333997861
Email
thong.dq@umc.edu.vn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long D Vo, MD, PhD
Organizational Affiliation
University Medical Center HCMC, VN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Ho Chi Minh City
City
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No

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Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer

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