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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Peristaltic Direction; Roux-en-Y Gastrointestinal Anastomosis
• Intervention / Treatment: Procedure: Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction

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.

• Study Type: Interventional
• Enrollment (Anticipated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingyu Deng, M.D.; Phone Number: +86-22-23340123; Email: dengery@126.com
• Study Contact Backup: Name: Han Liang, M.D.; Phone Number: +86-22-23340123; Email: tjlianghan@126.com

Study Locations

• China
  • Tianjin, China, 300060
    • Recruiting
    • Cancer Hospital of Tianjin Medical University
    • Contact: Jingyu Deng, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antiperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group; The isoperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was consistent.	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.
Active Comparator: Isoperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group; The antiperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was opposite.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early postoperative recovery results	Differences of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.)	Within 1 month after surgery
Late postoperative recovery results	Differences of late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.)	1 year after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative incision infection, anastomotic leakage, intestinal obstruction, reoperation and readmission, etc	Within 1 month after surgery

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 14, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: DJY002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No