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

NCT05356520 | Recruiting

• 1 other identifier: XJ MZC 2022 04
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of esophagogastric junction has been increasing in recent years, and surgery is an important method for the treatment of adenoma at the esophagogastric junction. Currently, there is a great controversy about the surgical method of Siewert II, mainly choosing the right chest or the left chest for thoracic surgery. Therefore, it is of great significance to further study the surgical methods of Siewert II esophagogastric junction adenoma. Objective: To compare the safety, feasibility, and clinical efficacy of endoscopic Ivor-Lewis versus laparoscopic extended abdominal gastrectomy for Siewert type Ⅱadenocarcinoma at the resectable esophagogastric junction.

Conditions

Siewert Type II Adenocarcinoma of Esophagogastric Junction

Outcome Measures

Primary Outcomes (1)

• Disease-free survival time

  The time from the date of surgery to the patient's death from any cause

  three years

Secondary Outcomes (4)

• Overall survival

  five years

• Incidence of postoperative complications

  a month

• Postoperative mortality

  a month

• Tumor recurrence

  three years

Study Arms (2)

The experimental group

EXPERIMENTAL

Endoscopic ivor-Lewis operation was performed for siwert type II adenoma at the esophagogastric junction

Procedure: Endoscopy Ivor-lewis

The control group

ACTIVE COMPARATOR

Laparoscopic transabdominal enlarged gastrectomy for siwert TYPE II adenoma at the esophagogastric junction was performed

Procedure: Laparoscopic transabdominal enlarged gastrectomy

Interventions

Endoscopy Ivor-lewis PROCEDURE

Endoscopy Ivor-lewis

The experimental group

Laparoscopic transabdominal enlarged gastrectomy PROCEDURE

Laparoscopic transabdominal enlarged gastrectomy

The control group

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed EGJ type II adenocarcinoma
• ··The tumor can be removed by laparoscopy through the gastrodiaphragmatic esophageal hiatus or by endoscopic Ivor Lewis operation
• Pretreatment stage CT1-4A, N0-3, M0
• For cT4a stage patients, their resectable properties must be clearly verified before randomization
• For locally advanced tumors (CT3-T4 or N+), all 4 cycles of chemotherapy (FLOT) were completed before surgery.
• to 75 years old
• ECOG score 0-2
• ASA \<4
• Good bone marrow function (leukocyte \> x 10 \^ 9 / l; Hemoglobin\> 9 g/dl. ·Platelet\>100×10\^9/ L), renal function (glomerular filtration rate \& GT; 60ml/min) and liver function (total bilirubin \&lt; 1.5 times normal (ULN), aspartate aminotransferase (AST\< 2.5x ULN, Alanine aminotransferase (ALT)\<3 x ULN)
• Patients and their family members voluntarily sign written informed consent

You may not qualify if:

• Histologically confirmed EGJ type I and III adenocarcinoma
• Tumor spread over 5 cm proximal to EGJ
• Clinically significant (active) heart disease (i.e. symptomatic coronary artery disease or myocardial infarction within the last 12 months) resulting in left ventricular ejection fraction\<50%(determined by echocardiography)
• Clinically significant lung diseases (forced expiratory volume in 1 second (FEV1)\<1.5 l/s)
• Pregnant women and nursing mothers
• Stump gastric cancer
• Borrmann Type 4 (Leather stomach)
• Simultaneous or heterochronous malignant tumors of other organs except carcinoma in situ of the cervix and adenoma and focal colorectal carcinoma
• Right thoracotomy or history of right pleural adhesion
• Cirrhosis, or indocyanine green test ≥15% of chronic liver disease
• No seizure control, central nervous system diseases or mental disorders
• History of upper abdominal surgery (except laparoscopic cholecystectomy)
• The patient has coagulation dysfunction and cannot be corrected
• Patients with heart, lung, liver, brain, kidney and other important organ failure
• Patients with metabolic diseases such as diabetes

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead
• Tang-Du Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• General Hospital of Ningxia Medical University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator

Study Sites (1)

Li

Xi'an, Shaanxi, 710000, China

RECRUITING

Related Publications (1)

• Yue C, Mo Z, Wu X, Wang Y, Yang Q, Wang W, Zhou H, Gao R, Ji P, Dong D, Zhang Y, Ji G, Li X. 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. Front Oncol. 2023 Mar 30;13:1091615. doi: 10.3389/fonc.2023.1091615. eCollection 2023.

  PMID: 37064105 DERIVED

Study Officials

• xiaohua li, MD,PH.D

  Xijing Hospital

  STUDY CHAIR

• xianli he, MD,PH.D

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

• peichun sun, MD,PH.D

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• lei wang, MD,PH.D

  General Hospital of Ningxia Medical University

  PRINCIPAL INVESTIGATOR

• xuejun sun, MD,PH.D

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• he huang, MD,PH.D

  The First Affiliated Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaohua Li, MD,PH.D

CONTACT

+8613474299901; xjyylixiaohua@163.com

zhenchang Mo

CONTACT

+8618700816920; mzc131208@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 2, 2022
• Study Start: May 1, 2022
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2028
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

CN (1)