Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction
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|ClinicalTrials.gov Identifier: NCT04910789|
Recruitment Status : Recruiting
First Posted : June 2, 2021
Last Update Posted : June 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of Esophagogastric Junction||Procedure: transhiatal/transabdominal approach Procedure: thoracoabdominal approach||Not Applicable|
Objective: To compare the safety and clinical efficacy between transhiatal/transabdominal and thoracoabdominal approach for Siewert Ⅱ adenocarcinoma of esophagogastric junction.
Methods: A prospective, multi-center, randomized, controlled study will be performed. Patients who meet the eligibility criteria will be registered in the study and undergo radical surgery via transhiatal/transabdominal or thoracoabdominal approach. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.
The primary endpoints :3-year disease-free survival. The secondary endpoints:(1) Surgery and oncology indicators ;(2) The incidences of postoperative complications and mortality.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter, Randomized, Controlled Study Comparing Surgical Efficacy Between Transhiatal/Transabdominal and Thoracoabdominal Approach for Patients With Siewert II Adenocarcinoma of Esophagogastric Junction|
|Actual Study Start Date :||December 11, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Thoracoabdominal approach
Radical surgery should be finished via Thoracoabdominal approach.
Procedure: thoracoabdominal approach
Radical surgery should be finished via thoracoabdominal approach
Active Comparator: Transhiatal/transabdominal approach
Radical surgery should be finished via transhiatal/transabdominal approach.
Procedure: transhiatal/transabdominal approach
Radical surgery should be finished via transhiatal/transabdominal approach
- 3-year disease-free survival [ Time Frame: 3 years after surgery ]Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up
- The rate of R0-resection [ Time Frame: About 10 days after surgery ]The proportion of patients undergoing radical resection in all surgical patients
- The number of lymph node dissections and the positive [ Time Frame: About 10 days after surgery ]The number of lymph node dissections and the positive
- The duration of postoperative hospitalization [ Time Frame: Within 6 months after surgery ]Time from end of surgery to discharge
- The incidences of early postoperative complications [ Time Frame: Within 30 days after surgery ]The incidence of postoperative complications such as pneumonia, pleural effusion, anastomotic stenosis, anastomotic leakage, duodenal stump fistula, pancreatic fistula, abdominal abscess, and deep vein thrombosis (%).
- The incidence of perioperative mortality [ Time Frame: Within 30 days after surgery ]The incidence of death due to the surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04910789
|Contact: Xinxin Wang, Dremail@example.com|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Xinxin Wang, Dr. +8613811858199 firstname.lastname@example.org|