Adenocarcinoma of Esophagogastric JunctionNCT04910789
Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction
A study testing transhiatal/transabdominal approach and thoracoabdominal approach in people with Adenocarcinoma of Esophagogastric Junction, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adenocarcinoma of Esophagogastric Junction
- What is being tested?
- transhiatal/transabdominal approach and thoracoabdominal approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Xinxin Wang, Dr., +8613811858199, 301wxx@sina.com
About this study
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
To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction
Read the 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.
- Being tested
- transhiatal/transabdominal approach, thoracoabdominal approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transhiatal/transabdominal approachProcedure or surgery
Radical surgery should be finished via transhiatal/transabdominal approach
thoracoabdominal approachProcedure or surgery
Radical surgery should be finished via thoracoabdominal approach
| Study group | Role | What they receive |
|---|---|---|
| Thoracoabdominal approach | Experimental | Radical surgery should be finished via Thoracoabdominal approach. Receives: Procedure: thoracoabdominal approach |
| Transhiatal/transabdominal approach | Active comparator | Radical surgery should be finished via transhiatal/transabdominal approach. Receives: Procedure: transhiatal/transabdominal approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival
Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up
Measured: 3 years after surgery
Secondary outcomes (5)
The rate of R0-resection
The proportion of patients undergoing radical resection in all surgical patients
Measured: About 10 days after surgery
The number of lymph node dissections and the positive
The number of lymph node dissections and the positive
Measured: About 10 days after surgery
The duration of postoperative hospitalization
Time from end of surgery to discharge
Measured: Within 6 months after surgery
The incidences of early postoperative complications
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 (%).
Measured: Within 30 days after surgery
The incidence of perioperative mortality
The incidence of death due to the surgery
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start11 Dec 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of Esophagogastric JunctionStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chen, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910789
- Sponsor's protocol ID
- S2AEG
- Status last verified
- May 2021
- First submitted
- 20 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35331180
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04910789
- Acronym / sponsor ID
- S2AEG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracoabdominal approach | Experimental | Procedure: thoracoabdominal approachRadical surgery should be finished via Thoracoabdominal approach. |
| Transhiatal/transabdominal approach | Active comparator | Procedure: transhiatal/transabdominal approachRadical surgery should be finished via transhiatal/transabdominal approach. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transhiatal/transabdominal approachRadical surgery should be finished via transhiatal/transabdominal approach | Procedure or surgery | Transhiatal/transabdominal approach |
| thoracoabdominal approachRadical surgery should be finished via thoracoabdominal approach | Procedure or surgery | Thoracoabdominal approach |
Primary outcome
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
5 secondary outcomes
The rate of R0-resection
Time frame: About 10 days after surgery
The number of lymph node dissections and the positive
Time frame: About 10 days after surgery
The duration of postoperative hospitalization
Time frame: Within 6 months after surgery
The incidences of early postoperative complications
Time frame: Within 30 days after surgery
The incidence of perioperative mortality
Time frame: Within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Derived from this study: PubMed 35331180Song 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transhiatal/transabdominal approach and thoracoabdominal approach in people with Adenocarcinoma of Esophagogastric Junction, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinxin Wang, Dr (+8613811858199, 301wxx@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival (time frame: 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04910789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.