Gastric (Cardia, Body) CancerPhase 3BYQoL-GCNCT06768164
Quality of Life After Billroth II or Roux-en-Y for Gastric Cancer
A Phase 3 study testing Billroth 2 (B2) and Roux-En-Y (REY) in people with Gastric (Cardia, Body) Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The treatment of a local distal gastric cancer remains surgical before or after chemotherapy. Partial gastrectomy is recommended for distal location cancer The recommendations for restoring continuity are less evident. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric (Cardia, Body) Cancer
- What is being tested?
- Billroth 2 (B2) and Roux-En-Y (REY)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2026to Apr 2031
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years, men or women
- Patients treated for adenocarcinoma of the antrum accessible to a surgical treatment with curative intent by distal gastrectomy. If patients present a linitis plastica, negative proximal and distal margin will be evaluated at the beginning of the surgery before randomization in order to perform a R0 resection
- Patients with a registration in a national health care system (CMU included) (registered or being a beneficiary of such a scheme)
- Patients able to understand and fulfill questionnaires in French language
- Patients having given their written informed consent prior to participation in the study
Who cannot join
- Patients with preoperative peritoneal metastasis or distant metastasis
- Palliative surgery patients
- Patients under tutorship or curatorship and protected adults
- Patients on AME (Aide Médicale de l'Etat = State Medical Assistance)
- Patients deprived of liberty by judicial or administrative decision and patients under psychiatric care (admitted to a health or social care establishment)
- Patients unable to give their consent
- Pregnant or breastfeeding women
- Women of childbearing age without effective contraception
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Saint-Antoine
Paris, 75012
Alexandre CHALLINE, MD, PhD, 01 49 28 25 33 ext. +33, alexandre.challine@aphp.fr
Christelle AUGER, 01 71 76 07 53 ext. +33, christelle.auger@aphp.fr
About this study
Official title: Health-Related Quality Of Life After Partial Gastrectomy for Gastric Cancer: Comparison of Reconstruction by Billroth II or Roux-en-Y. A Randomized, Comparative, Multicentric, Single-blinded Study
The treatment of a local distal gastric cancer remains surgical before or after chemotherapy. Partial gastrectomy is recommended for distal location cancer The recommendations for restoring continuity are less evident. There are two main techniques: the Roux-En-Y (REY) requiring 2 anastomoses (gastro-jejunostomy and entero-enterostomy) and the Billroth 2 (B2) with a single anastomosis (gastro-jejunostomy). The choice remains matter of debate.
There was no difference on the global health status score from the QLQ-C30 questionnaire. However, the health-related quality of life (HRQoL) was significantly improved only in the REY group between pre- and post-gastrectomy. A significant difference for endoscopic gastritis in favor of the REY group was reported.
The purpose of this study is to determine which surgical technique improve the health related quality of life after distal gastrectomy.
Read the detailed description
The realization of REY suggests an improvement of the HRQoL after distal gastric resection in comparison to the B2 anastomosis justifying the need of a RCT on the topic. Moreover, the REY could improve the gastro-intestinal symptoms and gastritis. The investigators hypothesize that the REY intervention after distal gastrectomy will improve HRQoL for 3 targeted dimensions of the EORTC QLQ-OG25 questionnaire (eating, reflux, pain and discomfort) in patients with gastric cancer.
All patients with a distal gastric cancer treated in curative intent by surgery with distal gastrectomy should be included. The choice of this population belongs in the fact that no reconstruction according billroth2 are performed for other gastric cancer requiring a total gastrectomy. Therefore, all patients treated by total gastrectomy need to be excluded. Secondly, the increase in survival of this population in the past decade araising to 75% at 5 years allows investigators to question the quality of life after surgery.
The anastomosis is realized with the proximal jejunum without entero-enterostomy in the first 70 cm after the angle of Treitz. The gastrojejunostomy could be ante-colic or trans-mesocolic. The anastomosis could be performed according the surgeon decision (mechanical or handsewn, isoperistaltic or anisoperistaltic).
The length of jejunum of the Y section needs to be at least 60 cm. The Roux-en-Y anastomosis could be antecolic or transmesocolic. The anastomosis could be realized according the surgeon decision (mechanical or handsewn, isoperistaltic or anisoperistaltic).
The choice between these two techniques will not add an increased risk to the patient since they are both recommended by national guidelines, they are both performed as standard care and there is no difference in Quality of Life at long term.
During surgery:
- A complete exploration of abdominal cavity is realized to avoid presence of peritoneal metastasis. This exploration is allowed by laparoscopy or open surgery
- The gastric tumor permits to realize R0 resection with 5 cm of resection margin according to the subtotal gastric resection on the line between the right side of gastro-esophageal junction and the end of the left gastro-omental artery
- In case of Linitis plastica, realization of anatomopathological examination of proximal margin without sign of tumoral involvement to access to randomization The type of surgery (B2 or REY) will be then determined by randomization
Interventions added for the research are:
- Randomization : the randomization will be realized by the investigator team
- One endoscopy at 1 year of follow-up after surgery
- Quality of Life questionnaires (EORTC QLQ-C30 and QLQ-OG25) at baseline, 3 months, 6 months, 1 year and 2 years of follow-up after surgery
Expected benefits for the participants: Improve HRQoL after distal gastrectomy. Patients will not be exposed to a specific risk as the two methods of reconstruction are described and used in the routine.
The design of the study (without excessive invasive exam) and the routine care monitoring associated to a better HRQoL evaluation compared to the "classic" post-operative follow-up of patient will help patient decision to participate to the study.
- Conditions
- Gastric (Cardia, Body) Cancer
- Being tested
- Billroth 2 (B2), Roux-En-Y (REY)
- Keywords
- gastric cancer, gastrectomy
- Medical subject headings
- Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Billroth 2 (B2)Procedure or surgery
B2 technique requires a single anastomosis (gastro-jejunostomy) after distal gastrectomy
Roux-En-Y (REY)Procedure or surgery
REY technique requires 2 anastomoses (gastro-jejunostomy and entero-enterostomy) after distal gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Billroth 2 (B2) | Experimental | Not described Receives: Procedure: Billroth 2 (B2) |
| Roux-En-Y (REY) | Experimental | Not described Receives: Procedure: Roux-En-Y (REY) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQol with 3 targeted dimensions
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, OesophagoGastric 25 (EORTC QLQ-OG25) at 1 year post surgery with 3 targeted dimensions : eating, reflux, pain and discomfort. Health-related Quality of life (HRQoL) will be considered as being improved in one arm if at least one of the 3 targeted dimensions is significantly improved without a significantly deterioration for the other 2 targeted dimensions :
- Eating restrictions : [0-100].
- Reflux : [0-100].
- Pain and discomfort : [0-100]. If high scores = more problems.
Measured: One year post-surgery
Secondary outcomes (12)
Other EORTC QLQ-OG25 dimensions
Other dimensions of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, OesophagoGastric 25 (EORTC QLQ-OG25) questionnaire :
- Dysphagia : [0-100].
- Odynophagia : [0-100].
- Anxiety : [0-100]. If high scores = more problems.
Measured: Baseline, 3 months, 6 months, 1 year and 2 years post-surgery
Other HRQoL dimensions
Other dimensions of the HRQoL measured with the EORTC QLQ-C30 ( European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaires, Core 30) questionnaire will be described at baseline, 3 months, 6 months, 1 year and 2 years post-surgery :
- Physical function : [0-100].
- Role function : [0-100].
- Emotional function : [0-100].
- Cognitive function : [0-100].
- Social function : [0-100].
- Overall quality of life : [0-100]. For these dimensions above if high score = better function.
- Pain : [0-100].
- Fatigue : [0-100].
- Nausea and vomiting : [0-100]. For these dimensions above if high score = more problems.
Measured: Baseline, 3 months, 6 months, 1 year and 2 years post-surgery
Longitudinal changes of each HRQoL dimension
- The long-term HRQoL after surgery for gastric cancer at 2 years
Measured: The long-term HRQoL (EORTC QLQ-OG25 questionnaire) after surgery for gastric cancer at 2 years
Longitudinal changes of each HRQoL dimension
The long-Term HRQoL after surgery for gastric cancer at 2 years
Measured: et The long-term HRQoL (EORTC QLQ-C30 questionnaire) after surgery for gastric cancer at 2 years
The long-term HRQoL after surgery for gastric cancer at 2 years
The long-term HRQoL after surgery for gastric cancer at 2 years (EORTC QLQ-C30 )
Measured: 2 years post-surgery
The long-term HRQoL after surgery for gastric cancer at 2 years
The long-term HRQoL after surgery for gastric cancer at 2 years (EORTC QLQ-OG25)
Measured: 2 years post-surgery
The post-operative morbidity rates at 90 days
The postoperative morbidity at 90 days will be measured with the several following complications: Surgical site infection / leakage, gastroparesis, gastro-intestinal occlusion, stasis syndrome, dumping syndrome, ulcerative pathology
Measured: 90 days post-surgery
The post-operative morbidity rates at 1 year
The postoperative morbidity at 1 year post surgery will be measured with the several following complications: Surgical site infection / leakage, gastroparesis, gastro-intestinal occlusion, stasis syndrome, dumping syndrome, ulcerative pathology
Measured: 1 year post-surgery
The endoscopic biliary reflux rate and gastritis at 1 year post surgery
The biliary reflux and gastritis will be assessed by endoscopy at 1 year post-surgery
Measured: 1 year post-surgery
The rate of proton pump inhibitor (PPI) use at 3 months, 6 months, 1 year and 2 years post-surgery
The use of PPI will be measured by taking PPI in the past week at 3 months, 6 months, 1 year and 2 years post-surgery
Measured: 3 months, 6 months, 1 year and 2 years post-surgery
The survival at 1 year
The survival at 1 year post-surgery will be recorded by OS and DFS rate. DFS, defined as the time from surgery and locoregional recurrence, occurrence of distant metastases or second gastric cancer, or death (all causes) or the date of the last follow-up, at which point data will be censored.
OS, defined as the time from surgery to the death from any cause or the date of the last follow-up, at which point data will be censored.
Measured: 1 year post-surgery
The survival at 2 years
The survival at 2 years post-surgery will be recorded by OS and DFS rate. DFS, defined as the time from surgery and locoregional recurrence, occurrence of distant metastases or second gastric cancer, or death (all causes) or the date of the last follow-up, at which point data will be censored.
OS, defined as the time from surgery to the death from any cause or the date of the last follow-up, at which point data will be censored.
Measured: 2 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start20 Mar 2026
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric (Cardia, Body) CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Alexandre CHALLINE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768164
- Sponsor's protocol ID
- APHP210355
- Other IDs
- 2022-A00730-43
- Acronym
- BYQoL-GC
- Status last verified
- May 2026
- First submitted
- 24 Sep 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality Of Life After Partial Gastrectomy for Gastric Cancer: Comparison of Reconstruction by Billroth II or Roux-en-Y. A Randomized, Comparative, Multicentric, Single-blinded Study
- ClinicalTrials.gov ID
- NCT06768164
- Acronym / sponsor ID
- BYQoL-GC / APHP210355
- Conditions
- Gastric (Cardia, Body) Cancer
- Keywords
- gastric cancer, gastrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 10 Jan 2025 (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.
The treatment of a local distal gastric cancer remains surgical before or after chemotherapy. Partial gastrectomy is recommended for distal location cancer The recommendations for restoring continuity are less evident. There are two main techniques: the Roux-En-Y (REY) requiring 2 anastomoses (gastro-jejunostomy and entero-enterostomy) and the Billroth 2 (B2) with a single anastomosis (gastro-jejunostomy). The choice remains matter of debate.
There was no difference on the global health status score from the QLQ-C30 questionnaire. However, the health-related quality of life (HRQoL) was significantly improved only in the REY group between pre- and post-gastrectomy. A significant difference for endoscopic gastritis in favor of the REY group was reported.
The purpose of this study is to determine which surgical technique improve the health related quality of life after distal gastrectomy.
Detailed description
The realization of REY suggests an improvement of the HRQoL after distal gastric resection in comparison to the B2 anastomosis justifying the need of a RCT on the topic. Moreover, the REY could improve the gastro-intestinal symptoms and gastritis. The investigators hypothesize that the REY intervention after distal gastrectomy will improve HRQoL for 3 targeted dimensions of the EORTC QLQ-OG25 questionnaire (eating, reflux, pain and discomfort) in patients with gastric cancer.
All patients with a distal gastric cancer treated in curative intent by surgery with distal gastrectomy should be included. The choice of this population belongs in the fact that no reconstruction according billroth2 are performed for other gastric cancer requiring a total gastrectomy. Therefore, all patients treated by total gastrectomy need to be excluded. Secondly, the increase in survival of this population in the past decade araising to 75% at 5 years allows investigators to question the quality of life after surgery.
The anastomosis is realized with the proximal jejunum without entero-enterostomy in the first 70 cm after the angle of Treitz. The gastrojejunostomy could be ante-colic or trans-mesocolic. The anastomosis could be performed according the surgeon decision (mechanical or handsewn, isoperistaltic or anisoperistaltic).
The length of jejunum of the Y section needs to be at least 60 cm. The Roux-en-Y anastomosis could be antecolic or transmesocolic. The anastomosis could be realized according the surgeon decision (mechanical or handsewn, isoperistaltic or anisoperistaltic).
The choice between these two techniques will not add an increased risk to the patient since they are both recommended by national guidelines, they are both performed as standard care and there is no difference in Quality of Life at long term.
During surgery:
- A complete exploration of abdominal cavity is realized to avoid presence of peritoneal metastasis. This exploration is allowed by laparoscopy or open surgery
- The gastric tumor permits to realize R0 resection with 5 cm of resection margin according to the subtotal gastric resection on the line between the right side of gastro-esophageal junction and the end of the left gastro-omental artery
- In case of Linitis plastica, realization of anatomopathological examination of proximal margin without sign of tumoral involvement to access to randomization The type of surgery (B2 or REY) will be then determined by randomization
Interventions added for the research are:
- Randomization : the randomization will be realized by the investigator team
- One endoscopy at 1 year of follow-up after surgery
- Quality of Life questionnaires (EORTC QLQ-C30 and QLQ-OG25) at baseline, 3 months, 6 months, 1 year and 2 years of follow-up after surgery
Expected benefits for the participants: Improve HRQoL after distal gastrectomy. Patients will not be exposed to a specific risk as the two methods of reconstruction are described and used in the routine.
The design of the study (without excessive invasive exam) and the routine care monitoring associated to a better HRQoL evaluation compared to the "classic" post-operative follow-up of patient will help patient decision to participate to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Billroth 2 (B2) | Experimental | Procedure: Billroth 2 (B2) |
| Roux-En-Y (REY) | Experimental | Procedure: Roux-En-Y (REY) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥ 18 years, men or women
- Patients treated for adenocarcinoma of the antrum accessible to a surgical treatment with curative intent by distal gastrectomy. If patients present a linitis plastica, negative proximal and distal margin will be evaluated at the beginning of the surgery before randomization in order to perform a R0 resection
- Patients with a registration in a national health care system (CMU included) (registered or being a beneficiary of such a scheme)
- Patients able to understand and fulfill questionnaires in French language
- Patients having given their written informed consent prior to participation in the study
Key exclusion criteria (8 listed)
- Patients with preoperative peritoneal metastasis or distant metastasis
- Palliative surgery patients
- Patients under tutorship or curatorship and protected adults
- Patients on AME (Aide Médicale de l'Etat = State Medical Assistance)
- Patients deprived of liberty by judicial or administrative decision and patients under psychiatric care (admitted to a health or social care establishment)
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 |
|---|---|---|
| Billroth 2 (B2)B2 technique requires a single anastomosis (gastro-jejunostomy) after distal gastrectomy | Procedure or surgery | Billroth 2 (B2) |
| Roux-En-Y (REY)REY technique requires 2 anastomoses (gastro-jejunostomy and entero-enterostomy) after distal gastrectomy | Procedure or surgery | Roux-En-Y (REY) |
Primary outcome
HRQol with 3 targeted dimensions
Time frame: One year post-surgery
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, OesophagoGastric 25 (EORTC QLQ-OG25) at 1 year post surgery with 3 targeted dimensions : eating, reflux, pain and discomfort. Health-related Quality of life (HRQoL) will be considered as being improved in one arm if at least one of the 3 targeted dimensions is significantly improved without a significantly deterioration for the other 2 targeted dimensions : * Eating restrictions : [0-100]. * Reflux : [0-100]. * Pain and discomfort : [0-100]. If high scores = more problems.
12 secondary outcomes
Other EORTC QLQ-OG25 dimensions
Time frame: Baseline, 3 months, 6 months, 1 year and 2 years post-surgery
Other HRQoL dimensions
Time frame: Baseline, 3 months, 6 months, 1 year and 2 years post-surgery
Longitudinal changes of each HRQoL dimension
Time frame: The long-term HRQoL (EORTC QLQ-OG25 questionnaire) after surgery for gastric cancer at 2 years
Longitudinal changes of each HRQoL dimension
Time frame: et The long-term HRQoL (EORTC QLQ-C30 questionnaire) after surgery for gastric cancer at 2 years
The long-term HRQoL after surgery for gastric cancer at 2 years
Time frame: 2 years post-surgery
The long-term HRQoL after surgery for gastric cancer at 2 years
Time frame: 2 years post-surgery
The post-operative morbidity rates at 90 days
Time frame: 90 days post-surgery
The post-operative morbidity rates at 1 year
Time frame: 1 year post-surgery
The endoscopic biliary reflux rate and gastritis at 1 year post surgery
Time frame: 1 year post-surgery
The rate of proton pump inhibitor (PPI) use at 3 months, 6 months, 1 year and 2 years post-surgery
Time frame: 3 months, 6 months, 1 year and 2 years post-surgery
The survival at 1 year
Time frame: 1 year post-surgery
The survival at 2 years
Time frame: 2 years post-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 20 May 2026.
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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.
Alexandre CHALLINE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Billroth 2 (B2) and Roux-En-Y (REY) in people with Gastric (Cardia, Body) Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 8 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 20 May 2026. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alexandre CHALLINE, MD, PhD (+33 1 49 28 25 33, alexandre.challine@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQol with 3 targeted dimensions (time frame: One year post-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 20 May 2026.