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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
Sponsor:
Information provided by (Responsible Party):
Lin Chen, Chinese PLA General Hospital

Brief Summary:
To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction

Condition or disease Intervention/treatment Phase
Adenocarcinoma of Esophagogastric Junction Procedure: transhiatal/transabdominal approach Procedure: thoracoabdominal approach Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The rate of R0-resection [ Time Frame: About 10 days after surgery ]
    The proportion of patients undergoing radical resection in all surgical patients

  2. 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

  3. The duration of postoperative hospitalization [ Time Frame: Within 6 months after surgery ]
    Time from end of surgery to discharge

  4. 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 (%).

  5. The incidence of perioperative mortality [ Time Frame: Within 30 days after surgery ]
    The incidence of death due to the surgery



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.18~75 years old
  • 2.The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(SiewertⅡ) .
  • 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:

  • 1.Patients with distant metastasis (M1) or invasion of surrounding organs
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Xinxin Wang, Dr +8613811858199 301wxx@sina.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Xinxin Wang, Dr.    +8613811858199    301wxx@sina.com   
Sponsors and Collaborators
Chinese PLA General Hospital
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Responsible Party: Lin Chen, Prof., Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT04910789    
Other Study ID Numbers: S2AEG
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms