Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study on the Peristaltic Direction of Gastrointestinal Anastomosis in Roux-en-Y Reconstruction After Distal Curative Gastrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04801459
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of this study is intending to provide the optimal procedures of the peristaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer, which can provide the best operation mode of Roux-en-Y anastomosis in digestive tract reconstruction during distal gastrectomy for reducing postoperative complications and improving quality of life for patients.

Condition or disease Intervention/treatment Phase
Peristaltic Direction Roux-en-Y Gastrointestinal Anastomosis Gastric Cancer Procedure: Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single Center Randomized Prospective Study on the Peristaltic Direction of Gastrointestinal Anastomosis in Roux-en-Y Reconstruction After Distal Curative Gastrectomy for Gastric Cancer
Actual Study Start Date : April 2, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Antiperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group Procedure: Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction
In this study, intervention methods include two kind directions of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer. One is the isoperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. The other is the antiperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was opposite.
Isoperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group Procedure: Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction
In this study, intervention methods include two kind directions of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer. One is the isoperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. The other is the antiperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was opposite.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Early postoperative recovery results [ Time Frame: Within 1 month after surgery ]
    Differences of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.)

  2. Late postoperative recovery results [ Time Frame: 1 year after surgery ]
    Differences of late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.)


Other Outcome Measures:
  1. Postoperative complications [ Time Frame: Within 1 month after surgery ]
    Postoperative incision infection, anastomotic leakage, intestinal obstruction, reoperation and readmission, etc


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) Pathological examination confirmation the adenocarcinoma of stomach before surgery
  • 2) Physical conditions compliance with the requirements for curative gastrectomy
  • 3) Consent to undergo the D2 lymphadenectomy, and the dissected proportion of stomach no less than 2/3
  • 4) Comply with the protocol during the whole study period
  • 5) No neoadjuvant therapy administration
  • 6) Sign informed consent and permission of withdraw in the whole study period
  • 7) Consent to provide the tissue specimens after surgery for this study
  • 8) Estimation the overall survival after surgery no less than 6 months
  • 9) No anesthesia or operation contraindication disease
  • 10) cT1-4N0-2M0 stage demonstration by CT and endoscopic ultrasonography examinations
  • 11) Negative cytological detection in operation
  • 12) No seriously concomitance's diseases
  • 13) Karnofsky Performance Scores (KPS) more than 60
  • 14) Examined lymph node count no less than 16

Exclusion Criteria:

  • 1) Women during pregnant stage and breast-feed stage
  • 2) Women of childbearing age without any contraceptive measures
  • 3) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
  • 4) Immunosuppressive therapists for organ transplantation
  • 5) Seriously uncontrolled recurrent infection
  • 6) other malignant tumors
  • 7) No abilities of self-knowledge or mental disorders
  • 8) Participating in other clinical trials
  • 9) Siewert I and II esophagogastric junction tumors
  • 10) Serious internal diseases obstruction surgery
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04801459


Contacts
Layout table for location contacts
Contact: Jingyu Deng, M.D. +86-22-23340123 dengery@126.com
Contact: Han Liang, M.D. +86-22-23340123 tjlianghan@126.com

Locations
Layout table for location information
China
Cancer Hospital of Tianjin Medical University Recruiting
Tianjin, China, 300060
Contact: Jingyu Deng, M.D.         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
  Study Documents (Full-Text)

Documents provided by Tianjin Medical University Cancer Institute and Hospital:
Study Protocol  [PDF] October 30, 2020
Statistical Analysis Plan  [PDF] October 30, 2020
Informed Consent Form  [PDF] October 30, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT04801459    
Other Study ID Numbers: DJY002
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases