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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.
Gastric cancer is still one of the most common malignant tumors, and gastric antrum cancer is still common. Radical surgery is the only way to treat gastric antrum cancer, surgical procedures and reconstruction are closely related with the prognosis and quality of life, the choice is crucial. Gastrojejunostomy after distal gastrectomy may affect the quality of radical surgery, and postoperative diet, nutritional status and quality of life. More and more centers tend to choose Billroth II anastomosis, but patients prone to have a variety of complications, including reflux gastritis and bile reflux, malnutrition, seriously affecting the quality of life and so on. According to preliminary pilot study found that, uncut Roux-en-Y anastomosis way can keep the continuity of nerve-muscle function of the reconstruction of digestive tract, and closes the input in order to reduce the incidence of reflux, for improving the nutritional status and reducing complications and improve quality of life. Therefore, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| uncut Roux-en-Y anastomosis | Experimental | 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 |
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| Billroth II anastomosis | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uncut Roux-en-Y anastomosis | Procedure | Uncut Closure devices would be used to close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis | 0-5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun-Sheng Peng, PH.D | Contact | +862038254020 | chensh47@mail.sysu.edu.cn | |
| Shi Chen, PH.D | Contact | +862038254092 | cscp@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun-Sheng Peng, Ph.D | The sixth affliated hospital of Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The sixth affliated hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24480200 | Result | Yun 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. | |
| 24280449 | Result | Ahn 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. |
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The investigators would like to share the data to the Participating units.
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| Billroth II anastomosis | Procedure | Typical Billroth II anastomosis would be made after the Distal gastrectomy. |
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| 10769093 | Result | Mon 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. |
| 38421211 | Derived | Cai 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. |
| 31300019 | Derived | Chen 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. |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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