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

October 3, 2023 updated by: Changzhi People's Hospital Affiliated to Changzhi Medical College

Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract (Kamikawa Versus Single-Tract Jejunal Interposition Versus SOFY Reconstruction) After Proximal Gastrectomy

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In the trial, 180 patients with proximal early gastric cancer will be enrolled and then randomly assigned to one of three groups: Group A (Kamikawa, n = 60), Group B (single-tract jejunal interposition, n = 60), or Group C (SOFY reconstruction, n = 60). The general information, past medical history, laboratory and imaging findings, and surgical procedures of each patient will be recorded. Patients in Group A, Group B and Group C will receive Kamikaze reconstruction, single-tract jejunal interposition reconstruction and SOFY reconstruction respectively after standard proximal gastrectomy and lymph nodes dissection. The primary endpoint will be the incidence of reflux esophagitis, while the incidence of anastomotic leakage, anastomotic stenosis, operative time, and intraoperative blood loss will be secondary endpoints to compare the efficacy of these three reconstruction methods after proximal gastrectomy.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kamikawa reconstruction
Patients will be administered Kamikawa reconstruction after proximal gastrectomy.
Procedure: Kamikawa
Kamikawa reconstruction after proximal gastrectomy
Active Comparator: STJI reconstruction
Patients will be administered Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy.
Procedure: STJI
Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy
Active Comparator: SOFY reconstruction
Patients will be administered SOFY reconstruction after proximal gastrectomy.
Procedure: SOFY
SOFY reconstruction after proximal gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of reflux esophagitis
Time Frame: 24 months after surgery
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.
24 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of anastomotic leakage
Time Frame: 14 days after surgery
The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group.
14 days after surgery
incidence of anastomotic stenosis
Time Frame: 24 months after surgery
The percentage (%) of patients developing anastomotic stenosis after surgery in each group.
24 months after surgery
operative time
Time Frame: 1 day after surgery
The duration, measured in minutes, spent on reconstructing the digestive tract using specific method (Kamikawa, STJI or SOFY) following proximal gastrectomy.
1 day after surgery
intraoperative blood loss
Time Frame: 1 day after surgery
The amount of blood, measured in milliliters, lost during the reconstruction of digestive tract using specific method (Kamikawa, STJI or SOFY) following proximal gastrectomy.
1 day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changzhi People's Hospital Affiliated to Changzhi Medical College

Investigators

  • Study Chair: Wenqing Hu, Changzhi People's Hospital Affiliated to Changzhi Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020TD27

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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