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

NCT06347757 | Completed

• 1 other identifier: NorthernJiangsuhospital1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Anti-Reflux Alimentary Reconstruction; Laparoscopic Proximal Gastrectomy; Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction

Outcome Measures

Primary Outcomes (1)

• Incidence of reflux esophagitis

  At 1 year after LPG

Secondary Outcomes (5)

• Incidence of anastomotic leakage

  At 1 year after LPG

• Incidence of anastomotic stenosis

  At 1 year after LPG

• Operative time

  Intraoperative

• Intra-operative blood loss

  Intraoperative

• Overall survival, and disease-free survival

  At 1 and 3 years after LPG

Study Arms (3)

laparoscopic proximal gastrectomy with single-tract jejunal interposition reconstruction

EXPERIMENTAL

Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy

laparoscopic proximal gastrectomy with double-tract reconstruction

ACTIVE COMPARATOR

Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy

laparoscopic proximal gastrectomy with tube-like stomach reconstruction

ACTIVE COMPARATOR

Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy

Interventions

Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy PROCEDURE

laparoscopic proximal gastrectomy with single-tract jejunal interposition (LPG-STJI) versus double-tract reconstruction (LPG-DTR) versus tube-like stomach reconstruction (LPG-TLR).

laparoscopic proximal gastrectomy with double-tract reconstruction; laparoscopic proximal gastrectomy with single-tract jejunal interposition reconstruction; laparoscopic proximal gastrectomy with tube-like stomach reconstruction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-75 years old, male or female;
• 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);
• American Society of Anesthesiology physical status classification of I (indicating normal and healthy), II (indicating mild systemic disease), or III (indicating severe systemic disease);
• 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;
• Patients without contraindications to surgery;
• Voluntary participation by signing the written informed consent form approved by the institutional review board before study participation;

You may not qualify if:

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

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Jiajie Zhou

Yangzhou, China

Location

Related Publications (1)

• Tian Z, Cheng Y, Wang Y, Ren J, Wang S, Wang D. A 3-Arm case-matched analysis of anti-reflux reconstruction methods after laparoscopic proximal gastrectomy - Single tract jejunal interposition vs double tract reconstruction vs tube-like stomach reconstruction. Eur J Surg Oncol. 2025 Feb;51(2):109482. doi: 10.1016/j.ejso.2024.109482. Epub 2024 Nov 19.

  PMID: 39580964 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: March 15, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)