Clinical trial NCT02763878: Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy
Official title: Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nutrition Disorders
Postoperative Complications
Keywords: Uncut Roux-en-Y
Billroth II anastomosis
Distal gastric cancer
Nutrition status
Postoperative complications
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 832
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis
timeFrame: 0-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The sixth affliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The sixth affliated hospital of Sun Yat-sen University
name: Jun-Sheng Peng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.