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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02763878
• Other study ID #: CSGC-002
• Status: Recruiting
• Phase: Phase 3
• First received: February 5, 2016
• Last updated: July 18, 2017
• Start date: September 2016
• Est. completion date: December 2020

Study information

• Verified date: May 2017
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Jun-Sheng Peng, PH.D
• Phone: +862038254020
• Email: chensh47[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 832
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nutrition Disorders
• Postoperative Complications

Intervention

Procedure:
• Uncut Roux-en-Y anastomosis
Uncut Closure devices would be used to close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis.
• Billroth II anastomosis
Typical Billroth II anastomosis would be made after the Distal gastrectomy.

Locations

Country	Name	City	State
China	The sixth affliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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) — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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