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

Primary Purpose

Proximal Gastric Adenocarcinoma, Gastrectomy, Anastomosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kamikawa
STJI
SOFY
Sponsored by
Changzhi People's Hospital Affiliated to Changzhi Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Gastric Adenocarcinoma

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Kamikawa reconstruction

    STJI reconstruction

    SOFY reconstruction

    Arm Description

    Patients will be administered Kamikawa reconstruction after proximal gastrectomy.

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

    Patients will be administered SOFY reconstruction after proximal gastrectomy.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 25, 2023
    Last Updated
    October 3, 2023
    Sponsor
    Changzhi People's Hospital Affiliated to Changzhi Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06062225
    Brief Title
    Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    October 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changzhi People's Hospital Affiliated to Changzhi Medical College

    4. Oversight

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

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Proximal Gastric Adenocarcinoma, Gastrectomy, Anastomosis, Reflux Esophagitis, Postoperative Complications

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Kamikawa reconstruction
    Arm Type
    Experimental
    Arm Description
    Patients will be administered Kamikawa reconstruction after proximal gastrectomy.
    Arm Title
    STJI reconstruction
    Arm Type
    Active Comparator
    Arm Description
    Patients will be administered Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy.
    Arm Title
    SOFY reconstruction
    Arm Type
    Active Comparator
    Arm Description
    Patients will be administered SOFY reconstruction after proximal gastrectomy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Kamikawa
    Intervention Description
    Kamikawa reconstruction after proximal gastrectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    STJI
    Intervention Description
    Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    SOFY
    Intervention Description
    SOFY reconstruction after proximal gastrectomy
    Primary Outcome Measure Information:
    Title
    incidence of reflux esophagitis
    Description
    The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.
    Time Frame
    24 months after surgery
    Secondary Outcome Measure Information:
    Title
    incidence of anastomotic leakage
    Description
    The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group.
    Time Frame
    14 days after surgery
    Title
    incidence of anastomotic stenosis
    Description
    The percentage (%) of patients developing anastomotic stenosis after surgery in each group.
    Time Frame
    24 months after surgery
    Title
    operative time
    Description
    The duration, measured in minutes, spent on reconstructing the digestive tract using specific method (Kamikawa, STJI or SOFY) following proximal gastrectomy.
    Time Frame
    1 day after surgery
    Title
    intraoperative blood loss
    Description
    The amount of blood, measured in milliliters, lost during the reconstruction of digestive tract using specific method (Kamikawa, STJI or SOFY) following proximal gastrectomy.
    Time Frame
    1 day after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr.Hu
    Phone
    +8613509754125
    Email
    beibeihejiyy@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wenqing Hu
    Organizational Affiliation
    Changzhi People's Hospital Affiliated to Changzhi Medical College
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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