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

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06062225
• Other study ID #: 2020TD27
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: October 2026

Study information

• Verified date: September 2023
• Source: Changzhi People's Hospital Affiliated to Changzhi Medical College
• Contact: Dr.Hu
• Phone: +8613509754125
• Email: beibeihejiyy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: October 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Anastomosis
• Esophagitis
• Esophagitis, Peptic
• Gastrectomy
• Postoperative Complications
• Reflux Esophagitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changzhi People's Hospital Affiliated to Changzhi Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of reflux esophagitis	The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.	24 months after surgery
Secondary	incidence of anastomotic leakage	The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group.	14 days after surgery
Secondary	incidence of anastomotic stenosis	The percentage (%) of patients developing anastomotic stenosis after surgery in each group.	24 months after surgery
Secondary	operative time	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
Secondary	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.	1 day after surgery