Clinical trial · Interventional
A Study Comparing Billroth II With Roux-en-Y Reconstruction for Gastric Cancer
A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer
- 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)
Both Billroth II and Roux en Y are acceptable techniques of reconstruction after subtotal gastrectomy, however the debate one which is better remains unanswered. The aim of this study is to compare Billroth II and Roux en Y reconstruction techniques after radical distal subtotal gastrectomy for gastric cancer in terms of postoperative outcomes and quality of life. The investigators hypothesize that Roux en Y will have lesser gastrointestinal symptoms and reflux problems when compared to Billroth II reconstruction. Patients with resectable gastric cancer meeting the inclusion criteria will be consented and enrolled. Data on demographics, nutrition, gastrointestinal symptoms, and quality of life will be collected. They will be randomized after completion of distal subtotal gastrectomy to under go either Roux en Y or Billroth II reconstruction. Surgery data will be collected post-operatively. At 6 months follow up a repeat nutritional assessment using clinical and biochemical parameters will be carried out. The biochemical markers are part of routine follow up. The final assessment will be at the one year post surgery visit when by interview using EORTC 30 questionnaire quality of life data, gastrointestinal symptoms and nutritional assessment and surgery data for recurrence will be repeated. At one year patients will also have upper gastrointestinal endoscopy, which is part of routine follow up. At endoscopy stump gastritis will be graded and esophageal reflux assessed as per Los Angeles classification. It is postulated that 5% of the patients on Roux en Y reconstruction will experience poor clinical symptoms compared to 25% of those on Billroth II based on reflux symptoms. To achieve a statistical significance with 95% power and a 2-sided test of 5% for this 20% clinical difference, 80 subjects for each arm will be required. Factoring a 10% attrition rate for mortality and lost to follow up, a total of 160 subjects to be randomized equally will be recruited.
Conditions
Conditions (3)
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 | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Roux-en-Y or Billroth II | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Billroth II reconstruction
- description
- Following Radical Distal Subtotal Gastrectomy, patient will be randomised to restore the continuity of the intestine with the stomach using Billroth II reconstruction.
- interventionNames
- Procedure: Roux-en-Y or Billroth II
- type
- OTHER
- label
- Roux-en-Y reconstruction
- description
- Following Radical Distal Subtotal Gastrectomy, patient will be randomised to restore the continuity of the intestine with the stomach using Roux-en-Y reconstruction.
- interventionNames
- Procedure: Roux-en-Y or Billroth II
Primary outcomes (1)
- measure
- The aim of this study is to compare Billroth II and Roux En Y reconstruction after radical distal subtotal gastrectomy for gastric cancer in terms of postoperative outcomes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patient able to give informed consent * Age 21 - 80 years both male \& females * Patients with histopathologically confirmed adenocarcinoma of the distal lesser curve, distal greater curve, incisura and antrum that are deemed suitable for elective radical subtotal gastrectomy with curative intent. Exclusion Criteria: * Unable to give informed consent * Patients who have undergone previous gastrectomy * Patients with stomach cancer or previous small bowel surgery precluding construction of either form of anastomosis thus preventing randomization. * Patients operated for palliation of gastric outlet obstruction, bleeding, perforation and obstruction * Emergency gastrectomy for complications related to tumor. * Patients with early gastric cancer who can have curative treatment by endoscopic methods.
References
Publications (7)
- BACKGROUNDWoodward A, Sillin LF, Wojtowycz AR, Bortoff A. Gastric stasis of solids after Roux gastrectomy: is the jejunal transection important? J Surg Res. 1993 Sep;55(3):317-22. doi: 10.1006/jsre.1993.1148. PMID 8412117
- BACKGROUNDMathias JR, Fernandez A, Sninsky CA, Clench MH, Davis RH. Nausea, vomiting, and abdominal pain after Roux-en-Y anastomosis: motility of the jejunal limb. Gastroenterology. 1985 Jan;88(1 Pt 1):101-7. doi: 10.1016/s0016-5085(85)80140-2. PMID 3964759
- BACKGROUNDYoshino K. [History of gastric cancer surgery]. Nihon Geka Gakkai Zasshi. 2000 Dec;101(12):855-60. Japanese. PMID 11201113
- BACKGROUNDFukuhara K, Osugi H, Takada N, Takemura M, Higashino M, Kinoshita H. Reconstructive procedure after distal gastrectomy for gastric cancer that best prevents duodenogastroesophageal reflux. World J Surg. 2002 Dec;26(12):1452-7. doi: 10.1007/s00268-002-6363-z. Epub 2002 Oct 10. PMID 12370787
- RESULTOsugi H, Fukuhara K, Takada N, Takemura M, Kinoshita H. Reconstructive procedure after distal gastrectomy to prevent remnant gastritis. Hepatogastroenterology. 2004 Jul-Aug;51(58):1215-8. PMID 15239282
- RESULTNunobe S, Okaro A, Sasako M, Saka M, Fukagawa T, Katai H, Sano T. Billroth 1 versus Roux-en-Y reconstructions: a quality-of-life survey at 5 years. Int J Clin Oncol. 2007 Dec;12(6):433-9. doi: 10.1007/s10147-007-0706-6. Epub 2007 Dec 21. PMID 18071862
- RESULTIshikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0. PMID 16240061