search
Back to results

Study on the Peristaltic Direction of GI Anastomosis in Roux-en-Y Reconstruction

Primary Purpose

Peristaltic Direction, Roux-en-Y Gastrointestinal Anastomosis, Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peristaltic Direction

Eligibility Criteria

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

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

Sites / Locations

  • Cancer Hospital of Tianjin Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Antiperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group

Isoperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group

Arm Description

The isoperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was consistent.

The antiperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was opposite.

Outcomes

Primary Outcome Measures

Early postoperative recovery results
Differences of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.)
Late postoperative recovery results
Differences of late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.)

Secondary Outcome Measures

Full Information

First Posted
March 10, 2021
Last Updated
March 7, 2022
Sponsor
Tianjin Medical University Cancer Institute and Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04801459
Brief Title
Study on the Peristaltic Direction of GI Anastomosis in Roux-en-Y Reconstruction
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In this study, all 148 the included patients will underwent the distal curative gastrectomy for gastric cancer and will be performed the Roux-en-Y reconstruction for gastrointestinal anastomosis. Of them, 74 patients will be randomized in the group undergoing with the isoperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Meanwhile, the other 74 cases will be randomized in the group undergoing with the antiperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Then, we will evaluate the differencies of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.) and late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.) between above two group of patients, which will make an important contribution to reduce medical costs and potential improvements of the prognosis after distal curative gastrectomy for gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peristaltic Direction, Roux-en-Y Gastrointestinal Anastomosis, Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antiperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group
Arm Type
Experimental
Arm Description
The isoperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was consistent.
Arm Title
Isoperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group
Arm Type
Active Comparator
Arm Description
The antiperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was opposite.
Intervention Type
Procedure
Intervention Name(s)
Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Early postoperative recovery results
Description
Differences of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.)
Time Frame
Within 1 month after surgery
Title
Late postoperative recovery results
Description
Differences of late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.)
Time Frame
1 year after surgery
Other Pre-specified Outcome Measures:
Title
Postoperative complications
Description
Postoperative incision infection, anastomotic leakage, intestinal obstruction, reoperation and readmission, etc
Time Frame
Within 1 month after surgery

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingyu Deng, M.D.
Phone
+86-22-23340123
Email
dengery@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Han Liang, M.D.
Phone
+86-22-23340123
Email
tjlianghan@126.com
Facility Information:
Facility Name
Cancer Hospital of Tianjin Medical University
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingyu Deng, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study on the Peristaltic Direction of GI Anastomosis in Roux-en-Y Reconstruction

We'll reach out to this number within 24 hrs