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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic ESD arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic submucosal dissection with EndoRobotics traction device | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Rate of complete en bloc, one-piece resection with histologically-confirmed tumour-free lateral and vertical margins | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of procedural haemorrhage | 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. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip Wai Yan Chiu, MBChB, FRCSEd, FHKAM, MD | Contact | +852 35052627 | philipchiu@med.cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Hong Kong |
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|
| Rate of adjunctive procedure requirement |
Need of adjunctive procedures, during study procedure required to control bleeding (e.g. clips or haemostatic agents) |
| 30 days |
| All cause mortality rate | Mortality rate after procedure | up to 5 years |
| Rate of infection | Clinical sepsis with changes in inflammatory markers (WCC, CRP, temperature) | up to 12 months |
| Duration of procedure | Total time of ESD procedure | 1 day |
| Length of hospital stay | Length of hospital stay (in days) | 3 months |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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