Gastric CancerNCT06229197
Billroth II With Braun Anastomosis After Radical Distal Gastrectomy for Gastric Cancer
A study testing Billroth II reconstruction and Braun Anastomosis in people with Gastric Cancer and Surgery, run by Sichuan University.
Trial summary
The primary aim of this trial is to rigorously evaluate the comparative benefits and potential risks associated with Billroth II reconstruction with Braun anastomosis versus Billroth II reconstruction alone following distal gastrectomy with D2 lymphadenectomy in patients diagnosed with gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Surgery, Anastomosis
- What is being tested?
- Billroth II reconstruction and Braun Anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 31 Dec 2027
- 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
- To be enrolled, participants must be phase I-III patients with initial treatment of radical distal gastrectomy and satisfying the following inclusion criteria:
- Histologically proven stage I-III gastric cancer, evaluated as radically resectable
- No synchronous or metachronous cancers
- Patients have signed informed consent forms
- Age 18-80 years old
- No malfunction of cardio-pulmonary, liver, and kidney, ECOG score 0-1
- No emergency surgery needed
Who cannot join
- Patients will be excluded according to the following criteria:
- Pregnant or lactating women
- Distant metastasis to the liver, lung, bone, supraclavicular lymph nodes, pelvic, or ovarian species and peritoneal dissemination
- Ascites or cachexia
- Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension or diabetes
- Participation in other clinical trials 4 weeks before the enrollment of this trial or still participating in other trials
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- Mental illness
- Surgical history whose influence has not been eliminated
- History of another gastric or esophageal malignancy, including stromal tumor, sarcoma, lymphoma, and carcinoid
- Active infection with a fever of over 38°C
- Poor compliance
- Not suitable for this trial because of other clinical or laboratory conditions determined by the researchers
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Billroth II With Braun Anastomosis Versus Billroth II Anastomosis After Radical Distal Gastrectomy With D2 Lymphadenectomy for Gastric Cancer: a Randomized Controlled Trial
The primary aim of this trial is to rigorously evaluate the comparative benefits and potential risks associated with Billroth II reconstruction with Braun anastomosis versus Billroth II reconstruction alone following distal gastrectomy with D2 lymphadenectomy in patients diagnosed with gastric cancer. This assessment focuses on delineating the therapeutic efficacy, safety profile, and overall clinical outcomes of these two surgical approaches in treating this condition.
- Conditions
- Gastric Cancer, Surgery, Anastomosis, Gastrostomy
- Being tested
- Billroth II reconstruction, Braun Anastomosis
- Keywords
- Gastric Cancer, Gastrostomy, Billroth II, Braun Anastomosis
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Billroth II reconstructionProcedure or surgery
Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant
Braun AnastomosisProcedure or surgery
This is an additional surgical connection (anastomosis) created between two parts of the small intestine, specifically between the afferent (incoming) and efferent (outgoing) limbs of the jejunum near the gastrojejunostomy (the new connection between the stomach and small intestine created during a Billroth II procedure).
| Study group | Role | What they receive |
|---|---|---|
| Billroth II with Braun Reconstruction | Experimental | Not described Receives: Procedure: Billroth II reconstruction; Procedure: Braun Anastomosis |
| Billroth II Reconstruction | Active comparator | Not described Receives: Procedure: Billroth II reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of reflux gastritis assessed according to RGB classification
by endoscopic evaluation
Measured: 6 months, 12 months
Secondary outcomes (5)
Quality of life assessed by the PGSAS-45 Scale
The preoperative and postoperative QoL of patients between the two groups.
Measured: 6 months, 12 months
Nutritional status
Changes in body weight (kg) or BMI from baseline
Measured: 6 months, 12 months
Time to first passage of flatus/stool
Time taken to pass first stool or flatus
Measured: within 30 days after surgery
Postoperative complications (assessed according to the Clavien-Dindo)
e.g., anastomotic leakage, anastomotic bleeding assessed by laboratory test in combination with clinical features, radiological diagnostic methods, endoscopy, diagnostic laparoscopy.
Measured: within 30 days after surgery
Long-term complications
e.g., food residue and bile reflux (assessed according to the RGB classification).
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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.
- More trials run by Sichuan UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Zhang, MD, Sichuan University
- Investigators
- Bo Zhang, MD, Study chair, Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan UniversityZhaolun Cai, MD, PhD, Principal investigator, Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229197
- Sponsor's protocol ID
- 2023HXFH005
- Status last verified
- Jan 2024
- First submitted
- 1 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Billroth II With Braun Anastomosis Versus Billroth II Anastomosis After Radical Distal Gastrectomy With D2 Lymphadenectomy for Gastric Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06229197
- Acronym / sponsor ID
- 2023HXFH005
- Conditions
- Gastric Cancer, Surgery, Anastomosis, Gastrostomy
- Keywords
- Gastric Cancer, Gastrostomy, Billroth II, Braun Anastomosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jan 2024 (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 primary aim of this trial is to rigorously evaluate the comparative benefits and potential risks associated with Billroth II reconstruction with Braun anastomosis versus Billroth II reconstruction alone following distal gastrectomy with D2 lymphadenectomy in patients diagnosed with gastric cancer. This assessment focuses on delineating the therapeutic efficacy, safety profile, and overall clinical outcomes of these two surgical approaches in treating this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Billroth II with Braun Reconstruction | Experimental | Procedure: Billroth II reconstruction, Procedure: Braun Anastomosis |
| Billroth II Reconstruction | Active comparator | Procedure: Billroth II reconstruction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To be enrolled, participants must be phase I-III patients with initial treatment of radical distal gastrectomy and satisfying the following inclusion criteria:
- Histologically proven stage I-III gastric cancer, evaluated as radically resectable
- No synchronous or metachronous cancers
- Patients have signed informed consent forms
- Age 18-80 years old
Key exclusion criteria (12 listed)
- Pregnant or lactating women
- Distant metastasis to the liver, lung, bone, supraclavicular lymph nodes, pelvic, or ovarian species and peritoneal dissemination
- Ascites or cachexia
- Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension or diabetes
- Participation in other clinical trials 4 weeks before the enrollment of this trial or still participating in other trials
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 II reconstructionBillroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant | Procedure or surgery | Billroth II Reconstruction, Billroth II with Braun Reconstruction |
| Braun AnastomosisThis is an additional surgical connection (anastomosis) created between two parts of the small intestine, specifically between the afferent (incoming) and efferent (outgoing) limbs of the jejunum near the gastrojejunostomy (the new connection between the stomach and small intestine created during a Billroth II procedure). | Procedure or surgery | Billroth II with Braun Reconstruction |
Primary outcome
Incidence of reflux gastritis assessed according to RGB classification
Time frame: 6 months, 12 months
by endoscopic evaluation
5 secondary outcomes
Quality of life assessed by the PGSAS-45 Scale
Time frame: 6 months, 12 months
Nutritional status
Time frame: 6 months, 12 months
Time to first passage of flatus/stool
Time frame: within 30 days after surgery
Postoperative complications (assessed according to the Clavien-Dindo)
Time frame: within 30 days after surgery
Long-term complications
Time frame: 6 months, 12 months
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 29 Jan 2024.
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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.
Bo Zhang, MD study chair
Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan University
Zhaolun Cai, MD, PhD principal investigator
Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan University
Questions about this trial
What is this clinical trial studying?
A study testing Billroth II reconstruction and Braun Anastomosis in people with Gastric Cancer and Surgery, run by Sichuan University.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Zhaolun Cai, MD, PhD (+86-028-85423610, caizhaolun@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of reflux gastritis assessed according to RGB classification (time frame: 6 months, 12 months). 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 29 Jan 2024.