Liver CancerNCT06369597
A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery
A study testing Robotic telesurgery and Laparoscopic surgery in people with Liver Cancer and Renal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a randomized controlled trial that will be preceded by a safety trial focusing on the safety and efficacy of robotic telesurgery. The hypothesis is that robotic telesurgery has a non-inferior primary endpoint event rate to local laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer, Renal Cancer, Rectal Cancer
- What is being tested?
- Robotic telesurgery and Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 31 Mar 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
- Liver Cancer:
- Age 18 - 75 years.
- Clinical diagnosis of primary hepatocellular carcinoma or benign tumor such as hepatic adenoma.
- Patients with hepatocellular carcinoma (BCLC stage 0-B) who were considered suitable for laparoscopic or robotic partial hepatectomy after MDT discussion, or benign tumor such as liver adenoma.
- ECOG score 0 ~ 1.
- Child-Pugh score 5 ~ 7.
Show all 16Show fewer
- Renal cancer:
- Age 18 - 75 years old.
- Clinical diagnosis of renal cancer (cT1-T2) or benign tumor such as renal malformation tumor.
- Patients with benign tumors such as renal cancer (cT1-T2) or renal staggered tumor who were considered amenable to laparoscopic or robotic partial nephrectomy after MDT discussion.
- ECOG score 0 ~ 1.
- Rectal cancer:
- Age 18 - 75 years old.
- Clinical diagnosis of rectal cancer (Stage I-III).
- Patients with primary rectal cancer who are considered amenable to laparoscopic or robotic radical rectal adenocarcinoma surgery after MDT discussion.
- ECOG score 0 ~ 1.
Who cannot join
- Liver Cancer:
- Pregnant and lactating women.
- Combination of other malignant tumors or other malignant tumors within 5 years before enrollment.
- Recipients of allogeneic organ transplantation.
- Severe dysfunction of heart, lung, kidney and other organs.
- Renal cancer:
Show all 17Show fewer
- Pregnant and lactating women.
- Lymph node metastasis, metastasis to other organs, previous surgical history of renal cancer, or any situation that cannot accept general anesthesia.
- Combination of other malignant tumors or combination of other malignant tumors within 5 years prior to enrollment.
- allogeneic organ transplant recipients.
- Severe dysfunction of heart, lungs, kidneys and other organs.
- Rectal cancer:
- patients with stage IV or complicated disease and emergency surgery.
- Pregnant and lactating women.
- Combination of other malignant tumors or combination of other malignant tumors within 5 years before enrollment.
- Allogeneic organ transplant recipients.
- Severe dysfunction of heart, lung, kidney and other organs.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Kuang Ming, PhD, 008687755766 ext. 8576, kuangm@mail.sysu.edu.cn
About this study
This is a randomized controlled trial that will be preceded by a safety trial focusing on the safety and efficacy of robotic telesurgery. The hypothesis is that robotic telesurgery has a non-inferior primary endpoint event rate to local laparoscopic surgery.
Read the detailed description
First, a safety run-in trial for robotic telesurgery will be conducted and evaluated according to "3+3 design". At least 3 patients of each cancer type (including liver cancer,renal cancer and rectal cancer) will be enrolled for robotic telesurgery. If there is a tumor type for which the prior safety trial is terminated, the subsequent randomized controlled trial will not include patients of that type.
Second, after passing the safety run-in trial, a randomized controlled trial will be performed. New patients with each cancer type who met the enrollment criteria will be randomly assigned to either the laparoscopic surgery group(control group) or the robotic telesurgery group (intervention group) (84 patients in each group, 168 patients in total) in a 1:1 two-group parallel design.
- Conditions
- Liver Cancer, Renal Cancer, Rectal Cancer
- Being tested
- Robotic telesurgery, Laparoscopic surgery
- Medical subject headings
- Liver Neoplasms, Kidney Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic telesurgeryProcedure or surgery
Telesurgery by domestic surgical robot
Laparoscopic surgeryProcedure or surgery
Local laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Robotic telesurgery | Experimental | Patients with liver cancer, renal cancer, rectal cancer will be treated by telesurgery. Receives: Procedure: Robotic telesurgery |
| Laparoscopic surgery | Active comparator | Patients with liver cancer, renal cancer, rectal cancer will be treated by laparoscopic surgery. Receives: Procedure: Laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complication
Overall complication events within 30 days of surgery or intraoperative emergency intermediate open surgery events as defined by the Clavin-Dindo grading system
Measured: One month after surgery
Secondary outcomes (5)
Surgical time (min)
Total time from the start of surgery after robotic or laparoscopic installation to the end of incision closure and the surgeon's operating time.
Measured: One month after surgery
Intraoperative blood loss (mL)
Total bleeding from the start of surgery to the end of incision suturing.
Measured: One month after surgery
Postoperative hospitalization days
Number of days from the day of surgery to the day of discharge.
Measured: One month after surgery
Physician satisfaction
A NASA-TLX quantification form was completed by the physician postoperatively.
Measured: One month after surgery
Remote metrics
Record data related to network transmission end-to-end latency time, jitter, and frame loss.
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Kuang, Sun Yat-sen University
- Investigators
- Kuang Ming, PhD, Principal investigator, First Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369597
- Sponsor's protocol ID
- Robot2024
- Status last verified
- Apr 2024
- First submitted
- 13 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06369597
- Acronym / sponsor ID
- Robot2024
- Conditions
- Liver Cancer, Renal Cancer, Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 17 Apr 2024 (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.
This is a randomized controlled trial that will be preceded by a safety trial focusing on the safety and efficacy of robotic telesurgery. The hypothesis is that robotic telesurgery has a non-inferior primary endpoint event rate to local laparoscopic surgery.
Detailed description
First, a safety run-in trial for robotic telesurgery will be conducted and evaluated according to "3+3 design". At least 3 patients of each cancer type (including liver cancer,renal cancer and rectal cancer) will be enrolled for robotic telesurgery. If there is a tumor type for which the prior safety trial is terminated, the subsequent randomized controlled trial will not include patients of that type.
Second, after passing the safety run-in trial, a randomized controlled trial will be performed. New patients with each cancer type who met the enrollment criteria will be randomly assigned to either the laparoscopic surgery group(control group) or the robotic telesurgery group (intervention group) (84 patients in each group, 168 patients in total) in a 1:1 two-group parallel design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic telesurgery | Experimental | Procedure: Robotic telesurgeryPatients with liver cancer, renal cancer, rectal cancer will be treated by telesurgery. |
| Laparoscopic surgery | Active comparator | Procedure: Laparoscopic surgeryPatients with liver cancer, renal cancer, rectal cancer will be treated by laparoscopic surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Liver Cancer:
- Renal cancer:
- Rectal cancer:
Key exclusion criteria (17 listed)
- Liver Cancer:
- Renal cancer:
- Rectal cancer:
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 telesurgeryTelesurgery by domestic surgical robot | Procedure or surgery | Robotic telesurgery |
| Laparoscopic surgeryLocal laparoscopic surgery | Procedure or surgery | Laparoscopic surgery |
Primary outcome
Surgical complication
Time frame: One month after surgery
Overall complication events within 30 days of surgery or intraoperative emergency intermediate open surgery events as defined by the Clavin-Dindo grading system
5 secondary outcomes
Surgical time (min)
Time frame: One month after surgery
Intraoperative blood loss (mL)
Time frame: One month after surgery
Postoperative hospitalization days
Time frame: One month after surgery
Physician satisfaction
Time frame: One month after surgery
Remote metrics
Time frame: One month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Liver Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
Kuang Ming, PhD principal investigator
First Affiliated Hospital of Sun Yat-sen University
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 telesurgery and Laparoscopic surgery in people with Liver Cancer and Renal Cancer, run by Sun Yat-sen 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 16 inclusion and 17 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 2024. 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 Kuang Ming, PhD (008687755766 ext. 8576, kuangm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical complication (time frame: One month after surgery). 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 2024.