A Multicenter Randomized Controlled Study of Siewert II Esophagogastric Junction Adenocarcinoma With Endoscopic Ivor-Lewis Approach Versus Laparoscopic Transabdominal Extended Gastrectomy
Sponsor study identifier
interventional
212
1 country
1
Study Start
May 1, 2022
Actual (reported)Primary Completion
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 27, 2022
Actual (reported)May 1, 2022
Actual (reported)May 2, 2022
Actual (reported)May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Disease-free survival time
The time from the date of surgery to the patient's death from any cause
three years
Overall survival
five years
Incidence of postoperative complications
a month
Postoperative mortality
a month
Tumor recurrence
three years
Endoscopic ivor-Lewis operation was performed for siwert type II adenoma at the esophagogastric junction
Laparoscopic transabdominal enlarged gastrectomy for siwert TYPE II adenoma at the esophagogastric junction was performed
Endoscopy Ivor-lewis
Laparoscopic transabdominal enlarged gastrectomy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Li
Xi'an, Shaanxi, 710000, China
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.
xiaohua li, MD,PH.D
Xijing Hospital
xianli he, MD,PH.D
Tang-Du Hospital
peichun sun, MD,PH.D
Henan Provincial People's Hospital
lei wang, MD,PH.D
General Hospital of Ningxia Medical University
First Submitted
April 27, 2022
First Posted
May 2, 2022
Study Start
May 1, 2022
Actual (reported)Primary Completion
May 31, 2025
Estimated (date passed)Classification of Adenocarcinoma of the Esophagogastric Junction
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xuejun sun, MD,PH.D
First Affiliated Hospital Xi'an Jiaotong University
he huang, MD,PH.D
The First Affiliated Hospital of Shanxi Medical University
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 8, 2024
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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