Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID05356520

A Multicenter Randomized Controlled Study Comparing Endoscopic Ivor-Lewis Versus Laparoscopic Transabdominal Extended Gastrectomy for Siewert II Esophagogastric Junction Adenocarcinoma

Led by Xijing Hospital of Digestive Diseases · Updated on 2024-11-08

212

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

X

Xijing Hospital of Digestive Diseases

Lead Sponsor

T

Tang-Du Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the best surgical method for treating Siewert type II adenocarcinoma of the esophagogastric junction, a condition where tumors occur at the junction between the esophagus and stomach. There is controversy about whether to use a right chest (endoscopic Ivor-Lewis) or left chest (laparoscopic extended abdominal gastrectomy) approach. This trial aims to compare the safety, feasibility, and clinical effectiveness of these two surgical techniques to improve patient outcomes. The study compares two procedures: the endoscopic Ivor-Lewis operation and the laparoscopic transabdominal extended gastrectomy, both used to remove tumors at the esophagogastric junction. Participants are randomly assigned to one of these two surgical methods. The trial is multicenter and randomized, designed to provide new clinical data to help standardize treatment for this specific type of tumor. During the study, participants will be monitored for disease-free survival over three years, with additional follow-up for overall survival up to five years. Researchers will also track postoperative complications, mortality within one month, and tumor recurrence over three years. Assessments include clinical evaluations and imaging before surgery and careful postoperative monitoring to measure treatment outcomes and safety. The total participation duration spans several years to capture these important results.

CONDITIONS

Brief Title

Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed esophagogastric junction type II adenocarcinoma
  • Tumor removable by laparoscopy through gastrodiaphragmatic esophageal hiatus or endoscopic Ivor-Lewis operation
  • Pretreatment stage CT1-4A, N0-3, M0
  • For cT4a stage, tumor must be clearly resectable before randomization
  • Completed 4 cycles of FLOT chemotherapy before surgery for locally advanced tumors (CT3-T4 or N+)
  • Age 18 to 75 years
  • ECOG performance status 0 to 2
  • ASA score less than 4
  • Good bone marrow function (leukocyte > 1x10^9/L; hemoglobin > 9 g/dl; platelet > 100x10^9/L)
  • Adequate renal function (glomerular filtration rate > 60 ml/min)
  • Adequate liver function (total bilirubin < 1.5 times normal; AST < 2.5x ULN; ALT < 3x ULN)
  • Voluntary written informed consent signed by patient and family
Not Eligible

You will not qualify if you...

  • Esophagogastric junction type I or III adenocarcinoma
  • Tumor spreads more than 5 cm above the esophagogastric junction
  • Significant active heart disease or recent myocardial infarction within 12 months with ejection fraction < 50%
  • Significant lung disease with forced expiratory volume in 1 second (FEV1) < 1.5 l/s
  • Pregnant or nursing women
  • Stump gastric cancer
  • Borrmann Type 4 stomach cancer (leather stomach)
  • Other simultaneous or previous malignant tumors except certain in situ or focal carcinomas
  • History of right thoracotomy or right pleural adhesion
  • Cirrhosis or indocyanine green test ≥ 15% indicating chronic liver disease
  • Uncontrolled seizures, central nervous system diseases, or mental disorders
  • History of upper abdominal surgery except laparoscopic cholecystectomy
  • Uncorrectable coagulation disorders
  • Failure of heart, lung, liver, brain, kidney, or other important organs
  • Metabolic diseases such as diabetes
  • Immunosuppressive therapy including organ transplantation or SLE
  • Serious uncontrolled recurrent infections or concomitant diseases
  • Diseases requiring simultaneous surgery
  • Emergency surgery required due to tumor complications such as bleeding, perforation, or obstruction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Surgical procedure with immediate hospitalization period

Participants undergo either endoscopic Ivor-Lewis operation or laparoscopic transabdominal enlarged gastrectomy for Siewert type II adenocarcinoma of the esophagogastric junction.

1 hospital stay for surgery and immediate recovery

Post-operative Follow-up

Duration - Up to 5 years including early postoperative period and long-term monitoring

Participants are monitored for postoperative complications, recovery, and tumor recurrence over the following months and years.

Approximately monthly visits for the first month, then periodic follow-up visits over several years

Trial Site Locations

Total: 1 location

1

Li

Xi'an, Shaanxi, China, 710000

Actively Recruiting

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Research Team

X

xiaohua Li, MD,PH.D

Z

zhenchang Mo

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Comparison of thoracoabdominal versus abdominal-transhiatal surgical approaches in Siewert type II adenocarcinoma at the esophagogastric junction: Protocol for a prospective multicenter randomized controlled trial.

Chao Yue, Zhenchang Mo, Xiao Wu...

https://pubmed.ncbi.nlm.nih.gov/37064105