Early Rectal Neoplasms
Conditions
Keywords
Early rectal neoplasms, Rectal adenomas, T1 rectal cancer, ESD, Endoluminal robotic system
Brief summary
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.
Interventions
PROCEDUREColorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System
Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System by Agilis Robotics
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with nonpedunculated early rectal neoplasms \>/= 2 cm in size in the rectum (\>/= 3 cm and \</= 18 cm from the anal verge) that are deemed not feasible for en bloc resection with conventional polypectomy or endoscopic mucosal resection (EMR) as judged by two experienced endoscopists * American Society of Anesthesiologists (ASA) grading I-III * Informed consent available
Exclusion criteria
* Presence of endoscopic signs of massive submucosal invasion (including excavated/depressed morphology, Kudo's pit pattern Type V, or Sano's capillary pattern Type IIIB) * Evidence of deep invasion on endorectal ultrasonography * Unfavorable histopathologic features on biopsy (mucinous cancer, poor differentiation, or gross submucosal invasion) * Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are indicated for surgical resection * Patients with recurrence from previous EMR or ESD * Patients with non-correctable coagulopathy * Patients with contraindications to general anesthesia * Vulnerable population (e.g., mentally disabled, pregnancy.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| En bloc resection rate | Perioperative | The definition of en bloc resection is resection with a single piece. |
| Perioperative complications | Up to 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | Perioperative | R0 resection is defined as complete resection of the neoplasm with clear lateral and deep margins at histology |
| Endoscopic Submucosal Dissection (ESD) procedure time | Perioperative | 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. |
| Endoscopic Submucosal Dissection (ESD) dissection speed | Perioperative | 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). |
| Conversion rate | Perioperative | Conversion rate is defined as an emergent change in the treatment plan to conventional endoscopic submucosal dissection (ESD) or transanal minimally invasive surgery (TAMIS) |
| 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 | — |
Countries
China
Contacts
CONTACTSimon SM Ng, MD
CONTACTKaori Futaba, MD
PRINCIPAL_INVESTIGATORSimon SM Ng, MD
Chinese University of Hong Kong
Outcome results
None listed