Clinical trial · Interventional
Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy
NCT02763878CI-TRIAL-00028734unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 investigators intend to conduct multi-center randomized controlled study to find if Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the long-term complications, affect the quality of life, and improve the prognosis, comparing to Billroth II anastomosis.
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 |
|---|---|---|---|
| Nutrition Disorders | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Billroth II anastomosis | Procedure | — | UNRESOLVED |
| Uncut Roux-en-Y anastomosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- uncut Roux-en-Y anastomosis
- description
- After distal gastrectomy, duodenal stump closure, side to side anastomosis was underwent on the remnant stomach and jejunum,which was 25cm from Treitz ligament. Then underwent side to side anastomosis between jejunum about 35cm distance from gastrojejunostomy and jejunum about 5cm from Triez ligament . close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis by using uncut Closure devices
- interventionNames
- Procedure: Uncut Roux-en-Y anastomosis
- type
- SHAM_COMPARATOR
- label
- Billroth II anastomosis
- description
- After distal gastrectomy, duodenal stump closure, the investigators first underwent remnant stomach and upper jejunum side anastomosis. Then choose the jejunum about 25cm from Treitz ligament, premenstrual colon using a disposable cutting closure (or tubular stapling) in the rear wall of the stomach and jejunum anastomosis, common opening was closed with the (barbed wire) hand-stitched. After that, steps were same with the group A.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. pathological diagnosed as the gastric carcinoma, the possibility of removal by the surgeon and imaging physician assessment. 2. no previous history of other malignancies combined. 3. patients have signed informed consent; 4. aged 18 to 80 years old, male or female patients; 5. cardiopulmonary, liver and kidney function was normal, ECOG physical status score of 0 to 1 (see Appendix); 6. the clinician determine the patient does not need emergency surgery; Exclusion Criteria: 1. pregnant or lactating women; 2. the liver, lung, bone, and other distant metastasis; 3. supraclavicular lymph nodes, pelvic or ovarian species, peritoneal dissemination, etc; 4. a large number of ascites, cachexia; 5. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension merger, diabetes patients; 6. or mental illness; 7. 4 weeks prior to enrollment participated or are participating in other clinical trials of patients; 8. had undergone surgery, and its influence has not been eliminated in the patient; 9. of the stomach or esophagus history of malignancy, including stromal tumor, sarcoma, lymphoma, carcinoid; 10. patients with active infection (infection causing fever above 38 ℃); 11. patients with poor compliance or researchers consider poor patient compliance; 12. There are other clinical researchers believe that the laboratory the patient should not participate in the trial.
References
Publications (5)
- RESULTYun SC, Choi HJ, Park JY, Kim YJ. Total laparoscopic uncut Roux-en-Y gastrojejunostomy after distal gastrectomy. Am Surg. 2014 Feb;80(2):E51-3. No abstract available. PMID 24480200
- RESULTAhn SH, Son SY, Lee CM, Jung DH, Park do J, Kim HH. Intracorporeal uncut Roux-en-Y gastrojejunostomy reconstruction in pure single-incision laparoscopic distal gastrectomy for early gastric cancer: unaided stapling closure. J Am Coll Surg. 2014 Jan;218(1):e17-21. doi: 10.1016/j.jamcollsurg.2013.09.009. Epub 2013 Nov 23. No abstract available. PMID 24280449
- RESULTMon RA, Cullen JJ. Standard Roux-en-Y gastrojejunostomy vs. "uncut" Roux-en-Y gastrojejunostomy: a matched cohort study. J Gastrointest Surg. 2000 May-Jun;4(3):298-303. doi: 10.1016/s1091-255x(00)80079-7. PMID 10769093
- DERIVEDCai Z, Mu M, Ma Q, Liu C, Jiang Z, Liu B, Ji G, Zhang B. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2. PMID 38421211
- DERIVEDChen S, Chen DW, Chen XJ, Lin YJ, Xiang J, Peng JS. Postoperative complications and nutritional status between uncut Roux-en-Y anastomosis and Billroth II anastomosis after D2 distal gastrectomy: a study protocol for a multicenter randomized controlled trial. Trials. 2019 Jul 12;20(1):428. doi: 10.1186/s13063-019-3531-0. PMID 31300019