Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy

Phase 3

• Conditions: Postoperative Complications; Nutrition Disorders

• Registration Number: NCT02763878
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-05
• Study Start: 2016-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 832

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The sixth affliated hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China