Esophagogastric Junction AdenocarcinomaNCT04153058
Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III AEG
A study testing Robotic Assisted AEG Radical Gastrectomy and Laparoscopic Assisted AEG Radical Gastrectomy in people with Esophagogastric Junction Adenocarcinoma, run by Fujian Medical University at 1 site in China.
Trial summary
The purpose of this study is to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma（cT2-4a, N-/+, M0） Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophagogastric Junction Adenocarcinoma
- What is being tested?
- Robotic Assisted AEG Radical Gastrectomy and Laparoscopic Assisted AEG Radical Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to Oct 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
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- Expected to perform total gastrectomy with D2+No.19+No.20 lymph node dissction to obtain R0 resection sugicall results.
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
Who cannot join
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Gastric multiple primary carcinoma
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
Show all 14Show fewer
- History of other malignant disease within the past 5 years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of the predicted values
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trials on Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
The purpose of this study is to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma（cT2-4a, N-/+, M0）
Read the detailed description
In recent years, the incidence of gastric cancer has been decreasing year by year in the world, but the incidence of adenocarcinoma of the esophagogastric junction (AEG) has shown a significant upward trend, especially in Western countries such as Europe and the United States. The prognosis of AEG is poor, therefore, it is extremely necessary to establish AEG's best diagnosis and treatment strategies to improve the long-term outcome of AEG. Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma (cT2-4a, N-/+, M0) by comparing with laparoscopic assisted.
- Conditions
- Esophagogastric Junction Adenocarcinoma
- Being tested
- Robotic Assisted AEG Radical Gastrectomy, Laparoscopic Assisted AEG Radical Gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted AEG Radical GastrectomyProcedure or surgery
Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
Laparoscopic Assisted AEG Radical GastrectomyProcedure or surgery
Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
| Study group | Role | What they receive |
|---|---|---|
| Robotic Assisted AEG Radical Gastrectomy | Experimental | Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma Receives: Procedure: Robotic Assisted AEG Radical Gastrectomy |
| Laparoscopic Assisted AEG Radical Gastrectomy | Active comparator | Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma Receives: Procedure: Laparoscopic Assisted AEG Radical Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival rate
3-year disease free survival rate
Measured: 36 months
Secondary outcomes (14)
3-year overall survival rate
3-year overall survival rate
Measured: 36 months
3-year recurrence pattern
3-year recurrence pattern
Measured: 36 months
overall postoperative morbidity rates
overall postoperative morbidity rates
Measured: 30 days
intraoperative morbidity rates
intraoperative morbidity rates
Measured: 1 day
overall postoperative serious morbidity rates
overall postoperative serious morbidity rates
Measured: 30 days
number of retrieved lymph nodes
number of retrieved lymph nodes
Measured: 14 days
Time to first ambulation
Time to first ambulation is used to access the postoperative recovery course.
Measured: 30 days
Time to first flatus
Time to first flatus is used to access the postoperative recovery course.
Measured: 30 days
Time to first liquid diet
Time to first liquid diet is used to access the postoperative recovery course.
Measured: 30 days
Time to soft diet
Time to soft diet is used to access the postoperative recovery course.
Measured: 30 days
Duration of hospital stay
Duration of hospital stay is used to access the postoperative recovery course.
Measured: 30 days
The amount of abdominal drainageare
The amount of abdominal drainageare is used to access the postoperative recovery course.
Measured: 30 days
postoperative nutritional status
Weight and height will be combined to report BMI in kg/m^2. The variation of BMI in kg/m^2 on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
Measured: 3, 6, 9 and 12 months
Hospitalization costs
Hospitalization costs
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Nov 2019
- Primary completionOct 2022 (estimated)
- Study completionOct 2025 (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.
- More trials run by Fujian Medical UniversityThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Chang-Ming Huang, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153058
- Sponsor's protocol ID
- FUGES-018
- Status last verified
- Feb 2020
- First submitted
- 20 Oct 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trials on Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04153058
- Acronym / sponsor ID
- FUGES-018
- Conditions
- Esophagogastric Junction Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 6 Nov 2019 (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.
The purpose of this study is to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma（cT2-4a, N-/+, M0）
Detailed description
In recent years, the incidence of gastric cancer has been decreasing year by year in the world, but the incidence of adenocarcinoma of the esophagogastric junction (AEG) has shown a significant upward trend, especially in Western countries such as Europe and the United States. The prognosis of AEG is poor, therefore, it is extremely necessary to establish AEG's best diagnosis and treatment strategies to improve the long-term outcome of AEG. Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma (cT2-4a, N-/+, M0) by comparing with laparoscopic assisted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Assisted AEG Radical Gastrectomy | Experimental | Procedure: Robotic Assisted AEG Radical GastrectomyRobotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma |
| Laparoscopic Assisted AEG Radical Gastrectomy | Active comparator | Procedure: Laparoscopic Assisted AEG Radical GastrectomyLaparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- Expected to perform total gastrectomy with D2+No.19+No.20 lymph node dissction to obtain R0 resection sugicall results.
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
Key exclusion criteria (14 listed)
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Gastric multiple primary carcinoma
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 |
|---|---|---|
| Robotic Assisted AEG Radical GastrectomyRobotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma | Procedure or surgery | Robotic Assisted AEG Radical Gastrectomy |
| Laparoscopic Assisted AEG Radical GastrectomyLaparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma | Procedure or surgery | Laparoscopic Assisted AEG Radical Gastrectomy |
Primary outcome
3-year disease free survival rate
Time frame: 36 months
3-year disease free survival rate
14 secondary outcomes
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
overall postoperative morbidity rates
Time frame: 30 days
intraoperative morbidity rates
Time frame: 1 day
overall postoperative serious morbidity rates
Time frame: 30 days
number of retrieved lymph nodes
Time frame: 14 days
Time to first ambulation
Time frame: 30 days
Time to first flatus
Time frame: 30 days
Time to first liquid diet
Time frame: 30 days
Time to soft diet
Time frame: 30 days
Duration of hospital stay
Time frame: 30 days
The amount of abdominal drainageare
Time frame: 30 days
postoperative nutritional status
Time frame: 3, 6, 9 and 12 months
Hospitalization costs
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Chang-Ming Huang principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Assisted AEG Radical Gastrectomy and Laparoscopic Assisted AEG Radical Gastrectomy in people with Esophagogastric Junction Adenocarcinoma, run by Fujian Medical University 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 14 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 5 Feb 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival rate (time frame: 36 months). 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 5 Feb 2020.