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Endoluminal surgery through natural orifices is an effective, "incisionless" treatment for benign lesions and early-stage cancers in the urinary tract and gastrointestinal (GI) tract. However, current practice suffers from the use of basic surgical instruments that lack dexterity and the ability to perform effective tissue retraction and provide triangulation. This is illustrated in endoscopic submucosal dissection (ESD) of GI tumors, which is a highly effective technique that has limited widespread adoption due to the exceptionally steep learning curve created by unintuitive and cumbersome instruments. It is suggested that a robotic system may improve en bloc resection capabilities in the GI tract by providing surgeons with dexterous and precise bimanual instrument control. This study aims to evaluate the clinical feasibility and safety of colorectal ESD using a novel endoluminal robotic system - the Intilume System by Agilis Robotics. It is a prospective, single center study consistent with a Stage 1 (Innovation) study described in the Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) framework. The primary study endpoints are en bloc resection rate and perioperative complications. The secondary study endpoints include R0 resection rate, dissection related metrics, conversion rate, and post-procedure recovery. This study will provide information on the feasibility and safety of the Intilume System developed by Agilis Robotics in performing colorectal ESD. This study may provide pertinent evidence for the continued development of this robotic technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System | Experimental | Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System by Agilis Robotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System | Procedure | Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System by Agilis Robotics |
| Measure | Description | Time Frame |
|---|---|---|
| En bloc resection rate | The definition of en bloc resection is resection with a single piece. | Perioperative |
| Perioperative complications | Perioperative complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification. | Up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | R0 resection is defined as complete resection of the neoplasm with clear lateral and deep margins at histology | Perioperative |
| Endoscopic Submucosal Dissection (ESD) procedure time |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simon SM Ng, MD | Contact | +852-35051495 | simonng@surgery.cuhk.edu.hk | |
| Kaori Futaba, MD | Contact | +852-35051495 | kfutaba@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Simon SM Ng, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital, The Chinese University of Hong Kong | Hong Kong | China |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C020149 | s-formylglutathione hydrolase |
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Endoscopic Submucosal Dissection (ESD) procedure time is defined as the total duration (in minutes) from the initial submucosal injection (or first marking) to the final removal of the lesion. It typically includes two phases: the circumferential mucosal incision (CIS) and the subsequent submucosal dissection (SDS) phase.
| Perioperative |
| Endoscopic Submucosal Dissection (ESD) dissection speed | Endoscopic Submucosal Dissection (ESD) dissection speed is defined as the surface area of the resected specimen (in cm² or mm²) divided by the time taken (in minutes or hours). | Perioperative |
| Conversion rate | Conversion rate is defined as an emergent change in the treatment plan to conventional endoscopic submucosal dissection (ESD) or transanal minimally invasive surgery (TAMIS) | Perioperative |
| Time to resume normal diet | Up to 1 month |
| Time to walk independently | Up to 1 month |
| Length of hospital stay | Up to 1 month |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |