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

Last updated: July 18, 2017
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02763878
CSGC-002
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. pathological diagnosed as the gastric carcinoma, the possibility of removal by thesurgeon 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 0to 1 (see Appendix);

  6. the clinician determine the patient does not need emergency surgery;

Exclusion

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 trialsof 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 shouldnot participate in the trial.

Study Design

Total Participants: 832
Study Start date:
September 01, 2016
Estimated Completion Date:
December 31, 2020

Study 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.

Connect with a study center

  • The sixth affliated hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510655
    China

    Active - Recruiting

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