Esophagogastric Junction AdenocarcinomaNCT04423354
A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Ⅱ AEG
A study testing Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction in people with Esophagogastric Junction Adenocarcinoma and Siewert Type II Adenocarcinoma of Esophagogastric Junction, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
Objective: To evaluate the safety, feasibility and clinical efficacy of transthoracic single-hole assisted laparoscopic radical gastrectomy for Siewert Type Ⅱ adenocarcinoma of esophagogastric junction. Methods: A prospective, single-center, one-arm study will be performed. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Esophagogastric Junction Adenocarcinoma, Siewert Type II Adenocarcinoma of Esophagogastric Junction
- What is being tested?
- Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2019to 31 Mar 2024
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent of patients;
- The tumor invaded the anatomy esophagogastric junction (EGJ), with the tumor center located at the EGJ line from 1cm above to 2cm below(SiewertⅡ).
- The endoscopic biopsy was diagnosed with adenocarcinoma;
- Preoperative clinical staging was cT1-4aNanyM0
- No distant metastasis and invasion of surrounding organs were found;
- ECOG score ranged from 0 to 1;
- ASA score ranged from I to III.
Who cannot join
- Pregnant or lactating women
- Have a severe mental illness
- History of esophagectomy and gastrectomy (including EMR / ESD for gastric and esophageal cancer)
- History of other malignant tumors within 5 years
- History of unstable angina pectoris or myocardial infarction within 6 months
- FEV1% of pulmonary function test was less than 50% of expected value
- History of cerebral infarction or cerebral hemorrhage within 6 months
- Have severe liver and kidney damage
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510120
Wei Wang, M.D.,PH.D., +86-13922255515, wangwei16400@163.com
Wenjun Xiong, M.D., +86-15920553177, xiongwj1988@163.com
About this study
Official title: A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
Objective: To evaluate the safety, feasibility and clinical efficacy of transthoracic single-hole assisted laparoscopic radical gastrectomy for Siewert Type Ⅱ adenocarcinoma of esophagogastric junction.
Methods: A prospective, single-center, one-arm study will be performed. Patients who have been diagnosed with Siewert type Ⅱ esophagogastric junction adenocarcinoma and meet the eligibility criteria will be included in the study and undergo the transthoracic single-hole assisted laparoscopic radical gastrectomy. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.
Read more
Primary study endpoints: The incidences of early postoperative complications and mortality.
The secondary study endpoints:(1) Surgery and oncology indicators ;(2) Early postoperative recovery information ;(3) 3-year disease-free survival and overall survival rate;(4) 5-year disease-free survival and overall survival.
Read the detailed description
- Surgery and oncology indicators,such as length of operation, intraoperative blood loss, transit thoracotomy or laparotomy rate, length of proximal tumor from esophageal resection margin, number of mediastinal lymph node dissections and the positive, number of abdominal lymph node dissections and the positive, tumor type and pathological stage, etc.;
- Early postoperative recovery information ,such as time of first exhaust and defecation, time of leaving the bed, time of recovery of full and half-flow diet, time of removal of chest drainage tube, time of postoperative hospitalization, etc.
- Conditions
- Esophagogastric Junction Adenocarcinoma, Siewert Type II Adenocarcinoma of Esophagogastric Junction
- Being tested
- Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric JunctionProcedure or surgery
Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy by the fixed surgical group.The same model surgical instruments will be provided by the same instrument company.
| Study group | Role | What they receive |
|---|---|---|
| Research group | Experimental | Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy. Receives: Procedure: Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidences of early perioperative complications
The early perioperative complications include anastomotic fistula, anastomotic stenosis, gastrointestinal dysfunction, chest or abdominal infection, chest or abdominal hemorrhage, respiratory complications, cardiovascular and cerebrovascular accidents, embolism and so on.
Measured: Within 30 days after surgery
Perioperative mortality
The incidence of death due to the surgery
Measured: Within 30 days after surgery
Secondary outcomes (20)
Duration of operation
The time it takes to complete the operation
Measured: From the beginning of anesthesia to the completion of surgery
Intraoperative blood loss
Total blood lost during surgery
Measured: From the beginning of anesthesia to the completion of surgery
The rate of transit thoracotomy or laparotomy
Thoracic or abdominal incisions greater than 10cm are considered to be converted to open chest or abdomen.
Measured: From the beginning of anesthesia to the completion of surgery
Intraoperative mortality
The rate of death during the surgery.
Measured: From the beginning of anesthesia to the completion of surgery
Proximal marginal distance
The length of proximal tumor from esophageal resection margin.
Measured: From the beginning of anesthesia to the completion of surgery
The number of mediastinal lymph node dissections and the positive
The mediastinal lymph nodes include NO.19,NO.20,NO.105,NO.106,NO.107,NO.108,NO.109,N0.110,NO.111,NO.112.
Measured: About 7 days.
The number of abdominal lymph node dissections and the positive
The abdominal lymph nodes include NO.1,NO.2,NO.3,NO.4,NO.5,NO.6,NO.7,NO.8,NO.9,NO.10,NO.11,NO.12,NO.13,NO.14.
Measured: About 7 days.
The tumor type
Such as squamous cell carcinoma, adenocarcinoma, etc.
Measured: About 7 days.
The pathological stage
Refer to AJCC 8th Edition TNM staging criteria for esophagus and esophagogastric junction cancer
Measured: About 7 days.
The duration of first exhaust
The duration from the end of the operation to the first exhaust after the operation.
Measured: Time from end of surgery to discharge,about 7 days.
The duration of first defecation
The duration from the end of the operation to the first defecation after the operation.
Measured: Time from end of surgery to discharge,about 7 days.
The duration of first leaving the bed
The duration from the end of the operation to the first leaving the bed after the operation.
Measured: Time from end of surgery to discharge,about 7 days.
The duration of restoration of full flow diet
The duration from the end of the operation to restore to a full-flow diet after the operation.
Measured: Time from end of surgery to discharge,about 7 days.
The duration of restoration of half-flow diet
The duration from the end of the operation to restore to a half-flow diet after the operation.
Measured: Time from end of surgery to discharge,about 7 days.
The duration of removal of chest drainage tube
The duration from the end of the operation to remove the chest drainage tube after the operation.
Measured: Time from end of surgery to discharge,about 7 days.
The duration of postoperative hospitalization
The duration from the end of the operation to hospital discharge.
Measured: Time from end of surgery to discharge,about 7 days.
3-year overall survival rate
Overall survival rate during 3 years after surgery
Measured: 3 years after surgery
3-year disease-free survival rate
Disease-free survival rate during 3 years after surgery
Measured: 3 years after surgery
5-year overall survival rate
Overall survival rate during 5 years after surgery
Measured: 5 years after surgery
5-year disease-free survival rate
Disease-free survival rate during 5 years after surgery
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start25 Mar 2019
- Primary completion1 Feb 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastric Junction AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- wei wang, M.D.,Ph.D, Principal investigator, Guangdong PHTCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423354
- Sponsor's protocol ID
- WWang
- Status last verified
- Jun 2020
- First submitted
- 26 Mar 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT04423354
- Acronym / sponsor ID
- WWang
- Conditions
- Esophagogastric Junction Adenocarcinoma, Siewert Type II Adenocarcinoma of Esophagogastric Junction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 9 Jun 2020 (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.
Objective: To evaluate the safety, feasibility and clinical efficacy of transthoracic single-hole assisted laparoscopic radical gastrectomy for Siewert Type Ⅱ adenocarcinoma of esophagogastric junction.
Methods: A prospective, single-center, one-arm study will be performed. Patients who have been diagnosed with Siewert type Ⅱ esophagogastric junction adenocarcinoma and meet the eligibility criteria will be included in the study and undergo the transthoracic single-hole assisted laparoscopic radical gastrectomy. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.
Primary study endpoints: The incidences of early postoperative complications and mortality.
The secondary study endpoints:(1) Surgery and oncology indicators ;(2) Early postoperative recovery information ;(3) 3-year disease-free survival and overall survival rate;(4) 5-year disease-free survival and overall survival.
Detailed description
- Surgery and oncology indicators,such as length of operation, intraoperative blood loss, transit thoracotomy or laparotomy rate, length of proximal tumor from esophageal resection margin, number of mediastinal lymph node dissections and the positive, number of abdominal lymph node dissections and the positive, tumor type and pathological stage, etc.;
- Early postoperative recovery information ,such as time of first exhaust and defecation, time of leaving the bed, time of recovery of full and half-flow diet, time of removal of chest drainage tube, time of postoperative hospitalization, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research group | Experimental | Procedure: Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric JunctionPatients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent of patients;
- The tumor invaded the anatomy esophagogastric junction (EGJ), with the tumor center located at the EGJ line from 1cm above to 2cm below(SiewertⅡ).
- The endoscopic biopsy was diagnosed with adenocarcinoma;
- Preoperative clinical staging was cT1-4aNanyM0
- No distant metastasis and invasion of surrounding organs were found;
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- Have a severe mental illness
- History of esophagectomy and gastrectomy (including EMR / ESD for gastric and esophageal cancer)
- History of other malignant tumors within 5 years
- History of unstable angina pectoris or myocardial infarction within 6 months
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 |
|---|---|---|
| Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric JunctionPatients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy by the fixed surgical group.The same model surgical instruments will be provided by the same instrument company. | Procedure or surgery | Research group |
Primary outcome
The incidences of early perioperative complications
Time frame: Within 30 days after surgery
The early perioperative complications include anastomotic fistula, anastomotic stenosis, gastrointestinal dysfunction, chest or abdominal infection, chest or abdominal hemorrhage, respiratory complications, cardiovascular and cerebrovascular accidents, embolism and so on.
Perioperative mortality
Time frame: Within 30 days after surgery
The incidence of death due to the surgery
20 secondary outcomes
Duration of operation
Time frame: From the beginning of anesthesia to the completion of surgery
Intraoperative blood loss
Time frame: From the beginning of anesthesia to the completion of surgery
The rate of transit thoracotomy or laparotomy
Time frame: From the beginning of anesthesia to the completion of surgery
Intraoperative mortality
Time frame: From the beginning of anesthesia to the completion of surgery
Proximal marginal distance
Time frame: From the beginning of anesthesia to the completion of surgery
The number of mediastinal lymph node dissections and the positive
Time frame: About 7 days.
The number of abdominal lymph node dissections and the positive
Time frame: About 7 days.
The tumor type
Time frame: About 7 days.
The pathological stage
Time frame: About 7 days.
The duration of first exhaust
Time frame: Time from end of surgery to discharge,about 7 days.
The duration of first defecation
Time frame: Time from end of surgery to discharge,about 7 days.
The duration of first leaving the bed
Time frame: Time from end of surgery to discharge,about 7 days.
The duration of restoration of full flow diet
Time frame: Time from end of surgery to discharge,about 7 days.
The duration of restoration of half-flow diet
Time frame: Time from end of surgery to discharge,about 7 days.
The duration of removal of chest drainage tube
Time frame: Time from end of surgery to discharge,about 7 days.
The duration of postoperative hospitalization
Time frame: Time from end of surgery to discharge,about 7 days.
3-year overall survival rate
Time frame: 3 years after surgery
3-year disease-free survival rate
Time frame: 3 years after surgery
5-year overall survival rate
Time frame: 5 years after surgery
5-year disease-free survival rate
Time frame: 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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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.
wei wang, M.D.,Ph.D principal investigator
Guangdong PHTCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction in people with Esophagogastric Junction Adenocarcinoma and Siewert Type II Adenocarcinoma of Esophagogastric Junction, run by Guangdong Provincial Hospital of Traditional Chinese Medicine 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 7 inclusion and 8 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 9 Jun 2020. 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 wei wang, M.D.,Ph.D (+86-13922255515, ww1640@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidences of early perioperative complications (time frame: Within 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2020.