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Not yet recruiting NCT06062225

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

No phase Interventional Proximal Gastric Adenocarcinoma Gastrectomy Anastomosis Reflux Esophagitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Kamikawa, STJI, SOFY.
Who it may be relevant to
Registry conditions: Proximal Gastric Adenocarcinoma, Gastrectomy, Anastomosis, Reflux Esophagitis. Basic parameters: 20 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Procedure Kamikawa
    Kamikawa reconstruction after proximal gastrectomy
  • Procedure STJI
    Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy
  • Procedure SOFY
    SOFY reconstruction after proximal gastrectomy

Primary outcome measures

  • incidence of reflux esophagitis [Time frame: 24 months after surgery]
Secondary outcome measures (4)
  • incidence of anastomotic leakage [Time frame: 14 days after surgery]
  • incidence of anastomotic stenosis [Time frame: 24 months after surgery]
  • operative time [Time frame: 1 day after surgery]
  • intraoperative blood loss [Time frame: 1 day after surgery]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06062225 · 2020TD27

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗