Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy

NCT06062225 | Not Yet Recruiting

• 1 other identifier: 2020TD27
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.

Conditions

Proximal Gastric Adenocarcinoma; Gastrectomy; Anastomosis; Reflux Esophagitis; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• incidence of reflux esophagitis

  The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.

  24 months after surgery

Secondary Outcomes (4)

• incidence of anastomotic leakage

  14 days after surgery

• incidence of anastomotic stenosis

  24 months after surgery

• operative time

  1 day after surgery

• intraoperative blood loss

  1 day after surgery

Study Arms (3)

Kamikawa reconstruction

EXPERIMENTAL

Patients will be administered Kamikawa reconstruction after proximal gastrectomy.

Procedure: Kamikawa

STJI reconstruction

ACTIVE COMPARATOR

Patients will be administered Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy.

Procedure: STJI

SOFY reconstruction

ACTIVE COMPARATOR

Patients will be administered SOFY reconstruction after proximal gastrectomy.

Procedure: SOFY

Interventions

Kamikawa PROCEDURE

Kamikawa reconstruction after proximal gastrectomy

Kamikawa reconstruction

STJI PROCEDURE

Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy

STJI reconstruction

SOFY PROCEDURE

SOFY reconstruction after proximal gastrectomy

SOFY reconstruction

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20-75 years old, male or female;
• Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC (15);
• No distant metastasis observed on preoperative chest radiograph, abdominal ultrasound or upper abdominal CT;
• ASA grade 1-3;
• Patients without contraindications to surgery;
• Patients and their families voluntarily signing the informed consent form and participating in the study;

You may not qualify if:

• Patients diagnosed with primary tumors or distant metastasis;
• Patients whose tumor is located in the greater curvature side of the stomach;
• Patients with coagulation dysfunction which could not be corrected;
• Patients who were diagnosed with viral hepatitis and cirrhosis;
• Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin;
• Patients with organ failure such as heart, lung, liver, brain, kidney failure;
• Patients with ascites or cachexia preoperatively in poor general conditions;
• Patients diagnosed with immunodeficiency, immunosuppression or autoimmune diseases (such as allogeneic bone marrow transplant, immunosuppressive drugs, SLE, etc.).
• Patients refusing to sign the informed consent of the study;

Sponsors & Collaborators

• Changzhi People's Hospital Affiliated to Changzhi Medical College: lead

MeSH Terms

Conditions

Esophagitis, Peptic; Postoperative Complications

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenqing Hu

  Changzhi People's Hospital Affiliated to Changzhi Medical College

  STUDY CHAIR

Central Study Contacts

Dr.Hu

CONTACT

+8613509754125; beibeihejiyy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share