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Trial Title:
A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery
NCT ID:
NCT06369597
Condition:
Liver Cancer
Renal Cancer
Rectal Cancer
Conditions: Official terms:
Kidney Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Robotic telesurgery
Description:
Telesurgery by domestic surgical robot
Arm group label:
Robotic telesurgery
Intervention type:
Procedure
Intervention name:
Laparoscopic surgery
Description:
Local laparoscopic surgery
Arm group label:
Laparoscopic surgery
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Liver Cancer:
1. Age 18 - 75 years.
2. Clinical diagnosis of primary hepatocellular carcinoma or benign tumor such as
hepatic adenoma.
3. 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.
4. ECOG score 0 ~ 1.
5. Child-Pugh score 5 ~ 7.
- Renal cancer:
1. Age 18 - 75 years old.
2. Clinical diagnosis of renal cancer (cT1-T2) or benign tumor such as renal
malformation tumor.
3. 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.
4. ECOG score 0 ~ 1.
- Rectal cancer:
1. Age 18 - 75 years old.
2. Clinical diagnosis of rectal cancer (Stage I-III).
3. Patients with primary rectal cancer who are considered amenable to laparoscopic
or robotic radical rectal adenocarcinoma surgery after MDT discussion.
4. ECOG score 0 ~ 1.
Exclusion Criteria:
- Liver Cancer:
1. Pregnant and lactating women.
2. Combination of other malignant tumors or other malignant tumors within 5 years
before enrollment.
3. Recipients of allogeneic organ transplantation.
4. Severe dysfunction of heart, lung, kidney and other organs.
- Renal cancer:
1. Pregnant and lactating women.
2. Lymph node metastasis, metastasis to other organs, previous surgical history of
renal cancer, or any situation that cannot accept general anesthesia.
3. Combination of other malignant tumors or combination of other malignant tumors
within 5 years prior to enrollment.
4. allogeneic organ transplant recipients.
5. Severe dysfunction of heart, lungs, kidneys and other organs.
- Rectal cancer:
1. patients with stage IV or complicated disease and emergency surgery.
2. Pregnant and lactating women.
3. Combination of other malignant tumors or combination of other malignant tumors
within 5 years before enrollment.
4. Allogeneic organ transplant recipients.
5. Severe dysfunction of heart, lung, kidney and other organs.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital, Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Contact:
Last name:
Kuang Ming, PhD
Phone:
008687755766
Phone ext:
8576
Email:
kuangm@mail.sysu.edu.cn
Start date:
April 15, 2024
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06369597
