Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04910789 |
Recruitment Status :
Recruiting
First Posted : June 2, 2021
Last Update Posted : June 2, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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, Dr | +8613811858199 | 301wxx@sina.com |
China, Beijing | |
Chinese PLA General Hospital | Recruiting |
Beijing, Beijing, China, 100853 | |
Contact: Xinxin Wang, Dr. +8613811858199 301wxx@sina.com |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Adenocarcinoma Esophageal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |