Gastric CancerNCT05344339
Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer
A study testing Distal gastrectomy in people with Gastric Cancer and Distal Gastrectomy, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Distal Gastrectomy
- What is being tested?
- Distal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteVietnam
- Study dates
- 8 Oct 2022to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000
Long D. Vo, MD., +84918133915, long.vd@umc.edu.vn
L D.
About this study
Official title: Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial
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.
Read the 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.
- Conditions
- Gastric Cancer, Distal Gastrectomy
- Being tested
- Distal gastrectomy
- Keywords
- Gastric Cancer, Distal gastrectomy, Reconstruction, Gastric adenocarcinoma, Roux-en-Y
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal gastrectomyProcedure or surgery
Reconstruction after Distal Gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Billroth-II modified | Experimental | 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 Receives: Procedure: Distal gastrectomy |
| Roux-en-Y | Active comparator | 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. Receives: Procedure: Distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux esophagistis
Findings of reflux esophagitis according to Los Angeles classification via endoscopy
Measured: on the 12th month after surgery
Secondary outcomes (15)
Early complications
Rate of any complications happened intraoperative and 30-days post-operative
Measured: 30 days after surgery
Operative time
Time from first incision to finishing abdomen closure, measured by surgical nurse
Measured: Intraoperative
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)
Measured: Intraoperative
Blood loss
Weighing of sucked blood and gauze, minus weighing of dry gauze
Measured: Intraoperative
Length of post-operative hospital stay
Number of days from date of surgery until date of discharge or mortality
Measured: 30 days after surgery or until mortality
Post gastrectomy syndromes
Rate of post gastrectomy syndromes after gastrectomy
Measured: from 30 days to 1 years after surgery
Bodyweight
Changing of patient's weight at the follow-up time compare to weight before surgery
Measured: on the 3rd, 6th, and 12th month after surgery
Serum total protein
Changing of patient's serum total protein at the follow-up time compare to serum protein before surgery
Measured: on the 3rd, 6th, and 12th month after surgery
Serum albumin
Changing of patient's serum albumin at the follow-up time compare to serum albumin before surgery
Measured: on the 3rd, 6th, and 12th month after surgery
Hemoglobin
Changing of patient's hemoglobin at the follow-up time compare to hemoglobin before surgery
Measured: on the 3rd, 6th, and 12th month after surgery
Changing of Gastric remnant gastritis
Grade of gastric remnant gastritis according to RGB classification (for endoscopy) and updated Sydney classification (for histology)
Measured: on the 6th, and 12th month after surgery
Changing of Residual food
Grade of Residual food according to RGB classification via endoscopy
Measured: on the 6th, and 12th month after surgery
Changing of bile reflux
Finding of bile reflux according to RGB classification via endoscopy
Measured: on the 6th, and 12th month after surgery
Changing of GSRS score
Patient's quality of life evaluated using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire
Measured: on the 3rd, 6th, and 12th month after surgery
6th month reflux esophagistis
Findings of reflux esophagitis according to Los Angeles classification via endoscopy
Measured: on the 6th month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start8 Oct 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomized control trial
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Long D Vo, MD, PhD, Principal investigator, University Medical Center HCMC, VN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344339
- Sponsor's protocol ID
- 15/GCN-HDDD
- Status last verified
- Dec 2023
- First submitted
- 8 Apr 2022
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05344339
- Acronym / sponsor ID
- 15/GCN-HDDD
- Conditions
- Gastric Cancer, Distal Gastrectomy
- Keywords
- Gastric Cancer, Distal gastrectomy, Reconstruction, Gastric adenocarcinoma, Roux-en-Y
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Billroth-II modified | Experimental | Procedure: Distal gastrectomyAn 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 |
| Roux-en-Y | Active comparator | Procedure: Distal gastrectomyJejunum 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal gastrectomyReconstruction after Distal Gastrectomy | Procedure or surgery | Billroth-II modified, Roux-en-Y |
Primary outcome
Reflux esophagistis
Time frame: on the 12th month after surgery
Findings of reflux esophagitis according to Los Angeles classification via endoscopy
15 secondary outcomes
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
Changing of bile reflux
Time frame: on the 6th, and 12th month after surgery
Changing of GSRS score
Time frame: on the 3rd, 6th, and 12th month after surgery
6th month reflux esophagistis
Time frame: on the 6th month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Long D Vo, MD, PhD principal investigator
University Medical Center HCMC, VN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal gastrectomy in people with Gastric Cancer and Distal Gastrectomy, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Long D. Vo, MD PhD (+84918133915, long.vd@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux esophagistis (time frame: on the 12th month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.