Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction
NCT ID: NCT04910789
Last Updated: 2021-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
312 participants
INTERVENTIONAL
2019-12-11
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Thoracoabdominal approach
Radical surgery should be finished via Thoracoabdominal approach.
thoracoabdominal approach
Radical surgery should be finished via thoracoabdominal approach
Transhiatal/transabdominal approach
Radical surgery should be finished via transhiatal/transabdominal approach.
transhiatal/transabdominal approach
Radical surgery should be finished via transhiatal/transabdominal approach
Interventions
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transhiatal/transabdominal approach
Radical surgery should be finished via transhiatal/transabdominal approach
thoracoabdominal approach
Radical surgery should be finished via thoracoabdominal approach
Eligibility Criteria
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Inclusion Criteria
* 2.The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(Siewertâ…¡) .
* 3.Histological diagnosis of adenocarcinoma
* 4\. American Society of Anesthesiologists(ASA) physical status class is less than or equal to 3
* 5.Informed consent of patients
Exclusion Criteria
* 2.History of esophagectomy and gastrectomy (including endoscopic mucosal resection/endoscopic submucosal dissection for gastric cancer and esophageal cancer)
* 3.History of other malignant tumors within 5 years
* 4.The researcher believes that the patient is not suitable to participate in the clinical trial
* 5.Patients who persist in withdrawing from clinical trials
18 Years
75 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Lin Chen
Prof.
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Song Q, Li X, Wu D, Li S, Xie T, Lu Y, Zhang L, Xu Z, Liu L, Guo X, Wang X. The abdominal-transhiatal surgical approach versus the thoracoabdominal surgical approach in Siewert type II adenocarcinoma of the esophagogastric junction: protocol for a multicenter prospective, open, parallel, and randomized controlled trial. BMC Cancer. 2022 Mar 24;22(1):318. doi: 10.1186/s12885-022-09375-w.
Other Identifiers
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S2AEG
Identifier Type: -
Identifier Source: org_study_id
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