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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

Tracking Information
First Submitted Date  ICMJE May 20, 2021
First Posted Date  ICMJE June 2, 2021
Last Update Posted Date June 2, 2021
Actual Study Start Date  ICMJE December 11, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2021)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction
Official Title  ICMJE A Prospective, Multicenter, Randomized, Controlled Study Comparing Surgical Efficacy Between Transhiatal/Transabdominal and Thoracoabdominal Approach for Patients With Siewert II Adenocarcinoma of Esophagogastric Junction
Brief Summary To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenocarcinoma of Esophagogastric Junction
Intervention  ICMJE
  • Procedure: transhiatal/transabdominal approach
    Radical surgery should be finished via transhiatal/transabdominal approach
  • Procedure: thoracoabdominal approach
    Radical surgery should be finished via thoracoabdominal approach
Study Arms  ICMJE
  • Experimental: Thoracoabdominal approach
    Radical surgery should be finished via Thoracoabdominal approach.
    Intervention: Procedure: thoracoabdominal approach
  • Active Comparator: Transhiatal/transabdominal approach
    Radical surgery should be finished via transhiatal/transabdominal approach.
    Intervention: Procedure: transhiatal/transabdominal approach
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2021)		 312
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xinxin Wang, Dr +8613811858199 301wxx@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04910789
Other Study ID Numbers  ICMJE S2AEG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Lin Chen, Chinese PLA General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Chinese PLA General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese PLA General Hospital
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP