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

Primary Purpose

Nutrition Disorders, Postoperative Complications

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Uncut Roux-en-Y anastomosis
Billroth II anastomosis
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nutrition Disorders focused on measuring Uncut Roux-en-Y, Billroth II anastomosis, Distal gastric cancer, Nutrition status, Postoperative complications

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The sixth affliated hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

uncut Roux-en-Y anastomosis

Billroth II anastomosis

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis

Secondary Outcome Measures

Full Information

First Posted
February 5, 2016
Last Updated
July 18, 2017
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02763878
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders, Postoperative Complications
Keywords
Uncut Roux-en-Y, Billroth II anastomosis, Distal gastric cancer, Nutrition status, Postoperative complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
832 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
uncut Roux-en-Y anastomosis
Arm Type
Experimental
Arm Description
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
Arm Title
Billroth II anastomosis
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Uncut Roux-en-Y anastomosis
Intervention Description
Uncut Closure devices would be used to close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis.
Intervention Type
Procedure
Intervention Name(s)
Billroth II anastomosis
Intervention Description
Typical Billroth II anastomosis would be made after the Distal gastrectomy.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis
Time Frame
0-5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pathological diagnosed as the gastric carcinoma, the possibility of removal by the surgeon and imaging physician assessment. no previous history of other malignancies combined. patients have signed informed consent; aged 18 to 80 years old, male or female patients; cardiopulmonary, liver and kidney function was normal, ECOG physical status score of 0 to 1 (see Appendix); the clinician determine the patient does not need emergency surgery; Exclusion Criteria: pregnant or lactating women; the liver, lung, bone, and other distant metastasis; supraclavicular lymph nodes, pelvic or ovarian species, peritoneal dissemination, etc; a large number of ascites, cachexia; suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension merger, diabetes patients; or mental illness; 4 weeks prior to enrollment participated or are participating in other clinical trials of patients; had undergone surgery, and its influence has not been eliminated in the patient; of the stomach or esophagus history of malignancy, including stromal tumor, sarcoma, lymphoma, carcinoid; patients with active infection (infection causing fever above 38 ℃); patients with poor compliance or researchers consider poor patient compliance; There are other clinical researchers believe that the laboratory the patient should not participate in the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-Sheng Peng, PH.D
Phone
+862038254020
Email
chensh47@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shi Chen, PH.D
Phone
+862038254092
Email
cscp@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-Sheng Peng, Ph.D
Organizational Affiliation
The sixth affliated hospital of Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The sixth affliated hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-Sheng Peng, Ph.D
Phone
+862038254020
Email
chensh47@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Shi Chen, Ph.D
Phone
+862038254092
Email
cscp@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators would like to share the data to the Participating units.
Citations:
PubMed Identifier
24480200
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.
Results Reference
result
PubMed Identifier
24280449
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.
Results Reference
result
PubMed Identifier
10769093
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.
Results Reference
result
PubMed Identifier
31300019
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.
Results Reference
derived

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

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