A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy

Not Applicable

Completed

• Conditions: Anti-Reflux Alimentary Reconstruction; Laparoscopic Proximal Gastrectomy; Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction
• Interventions: Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy

• Registration Number: NCT06347757
• Lead Sponsor: Northern Jiangsu People's Hospital

Brief Summary

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

Detailed Description

In the trial, 180 patients with early upper-third early gastric cancer and Siewert type II/III esophagogastric junction cancer will be enrolled and then randomly assigned to one of three groups: Group A (single-tract jejunal interposition n = 60), Group B (double-tract reconstruction, n = 60), or Group C (tube-like stomach reconstruction, n = 60). The primary co-end points were the incidence of reflux esophagitis at 2 years postoperatively. The secondary end points included the incidence of anastomotic leakage and anastomotic stenosis, operative time, intraoperative blood loss, quality of life, overall survival, and disease-free survival. Quality of life outcomes were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30-item core questionnaire (C30) and the EORTC QLQ stomach cancer-specific questionnaire at 3 months, 12 months, and 24 months.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2023-12-31
• Status Verified: 2024-03
• Study Completion: 2024-03-15
• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Study First Posted: 2024-04-04
• Last Update Submitted: 2024-04-28
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Age between 18-75 years old, male or female;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 (indicating fully active and able to continue all predisease activities without restriction) or 1 (indicating restricted in physically strenuous activities but ambulatory and able to perform work of a light or sedentary nature);
3. American Society of Anesthesiology physical status classification of I (indicating normal and healthy), II (indicating mild systemic disease), or III (indicating severe systemic disease);
4. 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;
5. Patients without contraindications to surgery;
6. Voluntary participation by signing the written informed consent form approved by the institutional review board before study participation;

Exclusion Criteria

1. Receipt of chemotherapy or radiotherapy for the treatment of GC before either surgical procedure
2. Combined resection required due to other diseases (except cholecystectomy).
3. History of cancer or concurrent cancer in other organs.
4. Previous or current receipt of treatment for systemic inflammatory disease or history of gastrectomy.
5. Patients with coagulation dysfunction which could not be corrected;
6. Vulnerable status (eg, lacking decision-making capacity, pregnant, or planning to become pregnant).
7. Receipt of chemotherapy or radiotherapy before either surgical procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic proximal gastrectomy with double-tract reconstruction	Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy	-
laparoscopic proximal gastrectomy with single-tract jejunal interposition reconstruction	Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy	-
laparoscopic proximal gastrectomy with tube-like stomach reconstruction	Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy	-

Primary Outcome Measures

Name	Time	Method
Incidence of reflux esophagitis	At 1 year after LPG

Secondary Outcome Measures

Name	Time	Method
Incidence of anastomotic leakage	At 1 year after LPG
Incidence of anastomotic stenosis	At 1 year after LPG
Intra-operative blood loss	Intraoperative
Operative time	Intraoperative
Overall survival, and disease-free survival	At 1 and 3 years after LPG

Trial Locations

Locations (1)

Jiajie Zhou; 🇨🇳 Yangzhou, China