Gastric CancerNCT04351321
The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy.
A study testing Totally Laparoscopic Total Gastrectomy and Laparoscopy-Assisted Total Gastrectomy in people with Gastric Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
To compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopic total gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Totally Laparoscopic Total Gastrectomy and Laparoscopy-Assisted Total Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Aug 2023
- 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
- Aged 18-75 years；
- Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
- Clinical stage cT1N0M0, cT1N1M0, cT2N0M0；
- The gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；
- BMI(Body Mass Index)<30 kg/m2；
- No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
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- No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；
- Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；
- Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
- Sufficient vital organ functions；
- Signed informed consent.
Who cannot join
- Preoperative examination indicates disease stage cStage II or above；
- Women during pregnancy or lactation；
- Suffer from other malignant tumors within 5 years；
- Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
- Severe mental illness；
- Severe respiratory disease；
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- Severe liver and kidney dysfunction；
- History of unstable angina or myocardial infarction within 6 months；
- History of cerebral infarction or cerebral hemorrhage within 6 months；
- Continuous application of glucocorticoid within 1 month (except for topical application)；
- Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
- The patient has participated in or is participating in other clinical studies (within 6 months).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy for Gastric Cancer.
To compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopic total gastrectomy.
- Conditions
- Gastric Cancer
- Being tested
- Totally Laparoscopic Total Gastrectomy, Laparoscopy-Assisted Total Gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totally Laparoscopic Total GastrectomyProcedure or surgery
Totally laparoscopic total gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.
Laparoscopy-Assisted Total GastrectomyProcedure or surgery
Laparoscopy-Assisted Total Gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| Totally Laparoscopic Total Gastrectomy | Experimental | Totally laparoscopic total gastrectomy will be performed for the treatment of patients assigned to this group. Receives: Procedure: Totally Laparoscopic Total Gastrectomy |
| Laparoscopy-Assisted Total Gastrectomy | Active comparator | Laparoscopy-assisted total gastrectomy will be performed for the treatment of patients assigned to this group. Receives: Procedure: Laparoscopy-Assisted Total Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative morbidity
Refers to the incidence of early postoperative complications. The early postoperative complications are defined as the events observed within postoperative 30 days.
Measured: 30 days
Secondary outcomes (3)
Quality of life score
Quality of life scores of the patients are evaluated based on EORTC C30 questionnaire at the 3rd, 6th and 12th months after operation.
Measured: 3, 6 and 12 months
Quality of life score
Quality of life scores of the patients are evaluated based on STO22 questionnaire at the 3rd, 6th and 12th months after operation.
Measured: 3, 6 and 12 months
Overall incidence of postoperative morbidity
Refers to the incidence of overall postoperative complications observed during follow-up period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study startJul 2020 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351321
- Sponsor's protocol ID
- CLASS08
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy for Gastric Cancer.
- ClinicalTrials.gov ID
- NCT04351321
- Acronym / sponsor ID
- CLASS08
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 17 Apr 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.
To compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopic total gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Totally Laparoscopic Total Gastrectomy | Experimental | Procedure: Totally Laparoscopic Total GastrectomyTotally laparoscopic total gastrectomy will be performed for the treatment of patients assigned to this group. |
| Laparoscopy-Assisted Total Gastrectomy | Active comparator | Procedure: Laparoscopy-Assisted Total GastrectomyLaparoscopy-assisted total gastrectomy will be performed for the treatment of patients assigned to this group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18-75 years；
- Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
- Clinical stage cT1N0M0, cT1N1M0, cT2N0M0；
- The gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；
- BMI(Body Mass Index)<30 kg/m2；
Key exclusion criteria (12 listed)
- Preoperative examination indicates disease stage cStage II or above；
- Women during pregnancy or lactation；
- Suffer from other malignant tumors within 5 years；
- Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
- Severe mental illness；
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 |
|---|---|---|
| Totally Laparoscopic Total GastrectomyTotally laparoscopic total gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection. | Procedure or surgery | Totally Laparoscopic Total Gastrectomy |
| Laparoscopy-Assisted Total GastrectomyLaparoscopy-Assisted Total Gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection. | Procedure or surgery | Laparoscopy-Assisted Total Gastrectomy |
Primary outcome
The incidence of postoperative morbidity
Time frame: 30 days
Refers to the incidence of early postoperative complications. The early postoperative complications are defined as the events observed within postoperative 30 days.
3 secondary outcomes
Quality of life score
Time frame: 3, 6 and 12 months
Quality of life score
Time frame: 3, 6 and 12 months
Overall incidence of postoperative morbidity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 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.
Questions about this trial
What is this clinical trial studying?
A study testing Totally Laparoscopic Total Gastrectomy and Laparoscopy-Assisted Total Gastrectomy in people with Gastric Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
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 11 inclusion and 12 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 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Zekuan Xu, M.D., Ph.D. (+86-025-68306844, xuzekuan@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative morbidity (time frame: 30 days). 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 17 Apr 2020.