Clinical trial · Interventional
Billroth II With Braun Anastomosis After Radical Distal Gastrectomy for Gastric Cancer
Billroth II With Braun Anastomosis Versus Billroth II Anastomosis After Radical Distal Gastrectomy With D2 Lymphadenectomy for Gastric Cancer: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomosis | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrostomy | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Billroth II reconstruction | Procedure | — | UNRESOLVED |
| Braun Anastomosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Billroth II with Braun Reconstruction
- interventionNames
- Procedure: Billroth II reconstruction
- Procedure: Braun Anastomosis
- type
- ACTIVE_COMPARATOR
- label
- Billroth II Reconstruction
- interventionNames
- Procedure: Billroth II reconstruction
Primary outcomes (1)
- measure
- Incidence of reflux gastritis assessed according to RGB classification
- timeFrame
- 6 months, 12 months
- description
- by endoscopic evaluation
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria To be enrolled, participants must be phase I-III patients with initial treatment of radical distal gastrectomy and satisfying the following inclusion criteria: 1. Histologically proven stage I-III gastric cancer, evaluated as radically resectable 2. No synchronous or metachronous cancers 3. Patients have signed informed consent forms 4. Age 18-80 years old 5. No malfunction of cardio-pulmonary, liver, and kidney, ECOG score 0-1 6. No emergency surgery needed Exclusion criteria Patients will be excluded according to the following criteria: 1. Pregnant or lactating women 2. Distant metastasis to the liver, lung, bone, supraclavicular lymph nodes, pelvic, or ovarian species and peritoneal dissemination 3. Ascites or cachexia 4. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension or diabetes 5. Participation in other clinical trials 4 weeks before the enrollment of this trial or still participating in other trials 6. Mental illness 7. Surgical history whose influence has not been eliminated 8. History of another gastric or esophageal malignancy, including stromal tumor, sarcoma, lymphoma, and carcinoid 9. Active infection with a fever of over 38°C 10. Poor compliance 11. Not suitable for this trial because of other clinical or laboratory conditions determined by the researchers
References
Publications (0)
Data not yet available