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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-75
SponsorChangzhi People's Hospital Affiliated to Changzhi Medical College

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Kamikawa

    Procedure/Surgery

    Kamikawa reconstruction after proximal gastrectomy

  • STJI

    Procedure/Surgery

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

  • SOFY

    Procedure/Surgery

    SOFY reconstruction after proximal gastrectomy

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Kamikawa reconstructionExperimental treatment 1 intervention
Group B: STJI reconstructionActive comparator 1 intervention
Group C: SOFY reconstructionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

incidence of reflux esophagitis

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

Time frame
24 months after surgery

Secondary outcomes

1

incidence of anastomotic leakage

The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group.

Time frame
14 days after surgery
2

incidence of anastomotic stenosis

The percentage (%) of patients developing anastomotic stenosis after surgery in each group.

Time frame
24 months after surgery
3

operative time

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
4

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.

Time frame
1 day after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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