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

A 3-Arm Study Comparing the Efficacy of Anti-Reflux Alimentary Reconstruction Protocols (Single-Tract Jejunal Interposition vs Double Tract vs Tube-Like Stomach Reconstruction) After Laparoscopic Proximal Gastrectomy

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Yangzhou, China
    • Jiajie Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laparoscopic proximal gastrectomy with single-tract jejunal interposition reconstruction	Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy; laparoscopic proximal gastrectomy with single-tract jejunal interposition (LPG-STJI) versus double-tract reconstruction (LPG-DTR) versus tube-like stomach reconstruction (LPG-TLR).
Active Comparator: laparoscopic proximal gastrectomy with double-tract reconstruction	Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy; laparoscopic proximal gastrectomy with single-tract jejunal interposition (LPG-STJI) versus double-tract reconstruction (LPG-DTR) versus tube-like stomach reconstruction (LPG-TLR).
Active Comparator: laparoscopic proximal gastrectomy with tube-like stomach reconstruction	Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy; laparoscopic proximal gastrectomy with single-tract jejunal interposition (LPG-STJI) versus double-tract reconstruction (LPG-DTR) versus tube-like stomach reconstruction (LPG-TLR).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of reflux esophagitis	At 1 year after LPG

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northern Jiangsu People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Estimated): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: NorthernJiangsuhospital1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No