Gastrointestinal Neoplasm
Conditions
Keywords
Endoscopic submucosal dissection
Brief summary
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
PROCEDUREEndoscopic 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 (ERBE, Germany) was used with endocut Q effect 3 and forced coagulation effect 3. Further submucosal dissection would be performed by electrocautery knife with traction achieved via EndoRobotics traction. Upon completion, the specimen would be retrieved upon withdrawal of the whole system.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | 30 days | Rate of complete en bloc, one-piece resection with histologically-confirmed tumour-free lateral and vertical margins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adjunctive procedure requirement | 30 days | Need of adjunctive procedures, during study procedure required to control bleeding (e.g. clips or haemostatic agents) |
| All cause mortality rate | up to 5 years | Mortality rate after procedure |
| Rate of procedural haemorrhage | 30 days | Hemorrhage at the resection site that requires transfusion, discontinuation of the procedure, or adjunctive open surgical control of haemorrhage, subcategorized by: Bleeding during the index procedure, or bleeding that occurs after the subject has left the procedure room after the index procedure. |
| Duration of procedure | 1 day | Total time of ESD procedure |
| Length of hospital stay | 3 months | Length of hospital stay (in days) |
| Rate of infection | up to 12 months | Clinical sepsis with changes in inflammatory markers (WCC, CRP, temperature) |
Countries
Hong Kong
Contacts
Primary ContactPhilip Wai Yan Chiu, MBChB, FRCSEd, FHKAM, MD
Outcome results
None listed