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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801459
• Other study ID #: DJY002
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2022
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Jingyu Deng, M.D.
• Phone: +86-22-23340123
• Email: dengery[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Peristaltic Direction
• Roux-en-Y Gastrointestinal Anastomosis
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Cancer Hospital of Tianjin Medical University	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative complications	Postoperative incision infection, anastomotic leakage, intestinal obstruction, reoperation and readmission, etc	Within 1 month after surgery
Primary	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
Primary	Late postoperative recovery results	Differences of late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.)	1 year after surgery