Clinical trial · Interventional
Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy
Phase III Study on Comparison for Bile Reflux and Gastric Stasis in Patients With Gastric Cancer After Distal Gastrectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): It was very difficult to enroll patients in this study.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrectomy | — | UNRESOLVED | — |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Billroth-II (B-II) | Procedure | — | UNRESOLVED |
| Roux en Y gastrojejunostomy (RY-GJ) | Procedure | — | UNRESOLVED |
| uncut Roux en Y gastrojejunostomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- 1
- description
- Billroth-II (B-II)reconstruction
- interventionNames
- Procedure: Billroth-II (B-II)
- type
- OTHER
- label
- 2
- description
- Roux en Y gastrojejunostomy (RY-GJ)
- interventionNames
- Procedure: Roux en Y gastrojejunostomy (RY-GJ)
- type
- OTHER
- label
- 3
- description
- uncut Roux en Y gastrojejunostomy (uncut RY-GJ)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who underwent distal gastrectomy for adenocarcinoma of stomach with following criteria: 1. have cancer located in middle or distal portions 2. preoperative staged as cT1N0M0 or cT2N0M0 by computed tomography and gastrofiberscope (Endoscopic ultrasound, optionally) 3. have The American Society of Anaesthesiologists (ASA) score of three and less Exclusion Criteria: * Patients following criteria: 1. have simultaneously other cancer 2. underwent cancer therapy (radiologic or immunologic or chemotherapeutic method) at past time 3. have systemic inflammatory disease 4. have upper gastrointestinal surgery 5. have the gastric cancer with obstruction 6. get pregnancy 7. are treating diabetics with Insulin 8. are participating or participated within 1 month in other clinical trials 9. have BMI less than 25 10. are expected to perform laparoscopy assisted gastrectomy
References
Publications (1)
- BACKGROUNDOgoshi K, Okamoto Y, Nabeshima K, Morita M, Nakamura K, Iwata K, Soeda J, Kondoh Y, Makuuchi H. Focus on the conditions of resection and reconstruction in gastric cancer. What extent of resection and what kind of reconstruction provide the best outcomes for gastric cancer patients? Digestion. 2005;71(4):213-24. doi: 10.1159/000087046. Epub 2004 Sep 6. PMID 16024924