Prospective Cohort Study on the Safety and Efficacy of Endorobotics for Endoscopic Submucosal Dissection (Endorobotics ESD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic submucosal dissection with EndoRobotics traction device.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Neoplasm. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This trial is a prospective, single arm study of 30 patients recruited to undergo endoscopic submucosal dissection (ESD) with a novel robotic assisted technology. It will assess the safety and performance of robotic-assisted endoscopic submucosal dissection (ESD) of superficial gastric and colorectal lesions that otherwise cannot be optimally and radically removed by snare-based techniques. The primary outcome of the study is rate of complete (R0) resection of the neoplasia.
Interventions
- Procedure Endoscopic submucosal dissection with EndoRobotics traction device
All patients received robotic ESD under general anesthesia or monitored anaesthetic care at the endoscopy center of Prince of Wales Hospital. The targeted lesion would first be localized and pre-injected using a mixture of normal saline, indigocarmine, epinephrine and sodium hyaluronate. The robotic endoscopic traction device was then inserted to reach the target. Mucosal incision first started from the anal side followed by lifting with the grasper\[Figure 1; Video 1\]. Vio 3 diathermy system (
Primary outcome measures
- R0 resection rate [Time frame: 30 days]
Secondary outcome measures (6)
- Rate of procedural haemorrhage [Time frame: 30 days]
- Rate of adjunctive procedure requirement [Time frame: 30 days]
- All cause mortality rate [Time frame: up to 5 years]
- Rate of infection [Time frame: up to 12 months]
- Duration of procedure [Time frame: 1 day]
- Length of hospital stay [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Patients with endoscopic diagnosis of early gastric or colorectal neoplasia
- Patients will be recruited according to ESGE and JGES guidelines for gastric \& colorectal ESD including: 1. Lesions for which en bloc resection with snare EMR is difficult to apply; 2. Mucosal tumors with submucosal fibrosis; 3. Sporadic tumors in conditions of chronic inflammation and 4. Local residual or recurrent early carcinomas after endoscopic resection.
Exclusion criteria
- Informed consent not available
- Carcinoma of colon or rectum or stomach with invasion to submucosa or beyond
- Evidence of distant metastasis
- Presence of another active malignancy
- Pregnancy
- Patients unfit for general anesthesia
- Endoscopic platform cannot reach target lesion
- Patients recruited into another clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Prince of Wales Hospital — Hong Kong
Identifiers
NCT: NCT06726798 · CUHK EndoRobotics