Clinical trial NCT01464918: Safety and Efficacy of Using MASTER to Perform Endoscopic Submucosal Dissection in Human
Official title: Safety and Efficacy of Using MASTER, a Novel Robotics Enhanced Endosurgical System to Perform Endoscopic Submucosal Dissection in Human
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Colon Cancer
Keywords: gastric cancer
colon cancer
endoscopic submucosal dissection
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Prince of Wales Hospital, Shatin, Hong Kong
name: Apollo Gleneagles Hospitals, Kolkata
First posted: 2011-11-04
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is to evaluate the safety and efficacy of using MASTER, a robotics enhanced endosurgical system to perform endoscopic submucosal dissection (ESD) of gastric/colon cancer in human.

Detailed description: This trial is to evaluate the safety and efficacy of using MASTER, a novel robotics enhanced endosurgical system to perform endoscopic submucosal dissection (ESD) of gastric/colon cancer in human. The MASTER is a master-and-slave robotic system that is deployed through a standard dual-channel therapeutic endoscope. It introduces robotic control of endoscopic surgical tools and tasks through an ergonomic human-machine interface built around the original endoscopic paradigm. In doing so, it separates control of instrumental motion from that of endoscopic movement such that surgical tasks may be independently executed by a second operator via a human-machine interface. With it, endoscopically deployed instruments can be independently controlled, allowing thus bimanual coordination of effector instruments to facilitate actions such as retraction/exposure, traction/countertraction, approximation and dissection of tissue. Using the MASTER, operational dexterity is increased, thus making it easier for the operator to perform the ESD procedure as compared with using the conventional endoscope. This study will measure the ease of using the MASTER to perform the various surgical tasks involved in the ESD procedure, the time taken to perform the procedure, and record complications, if any, occurred during and after the procedure.

Eligibility criteria: Inclusion Criteria:

* patient diagnosed with early gastric or colon cancer, is deemed suitable to undergo endoscopic submucosal dissection and is able/willing to give informed consent.

Exclusion Criteria:

* case is deemed not suitable for endoscopic submucosal dissection
* is on warfarin or other blood thinning agents and those with bleeding disorders
* has uncorrected coagulopathy or severe thrombocytopenia precluding biopsy
* has serious co-morbidities such as heart disease, renal impairment and cancer
* has recently underwent surgery or has a personal history of stomach/colon cancer or surgery
* is unable/unwilling to give informed consent
* is pregnant or breast-feeding women patients who cannot undergo gastroscopies

Primary outcomes:
measure: Total time taken to complete the ESD procedure
timeFrame: Participants will be followed for the duration of the operation, an expected average of 3 hours
Secondary outcomes:
measure: Measure of ease of performing the ESD procedure
timeFrame: Participants will be followed for the duration of the operation, an expected average of 3 hours
measure: Safety
timeFrame: From start of operation of the ESD procedure, assessed up to 7 days after the procedure
Other outcomes:
Locations:
city: Shatin
country: China
facility: Prince of Wales Hospital
state: Hong Kong
city: Kolkata
country: India
facility: Apollo Gleneagles Hospitals
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Khek Yu Ho, MBBS; MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phee SJ, Sun Z, Wang Z, Wong JY, Ho KY. The future of transluminal surgery. Expert Rev Med Devices. 2011 Nov;8(6):669-71. doi: 10.1586/erd.11.54. No abstract available.
citation: Sun Z, Ang RY, Lim EW, Wang Z, Ho KY, Phee SJ. Enhancement of a master-slave robotic system for natural orifice transluminal endoscopic surgery. Ann Acad Med Singap. 2011 May;40(5):223-30.
citation: Ho KY, Phee SJ, Shabbir A, Low SC, Huynh VA, Kencana AP, Yang K, Lomanto D, So BY, Wong YY, Chung SC. Endoscopic submucosal dissection of gastric lesions by using a Master and Slave Transluminal Endoscopic Robot (MASTER). Gastrointest Endosc. 2010 Sep;72(3):593-9. doi: 10.1016/j.gie.2010.04.009. Epub 2010 Jun 19.
citation: Phee SJ, Low SC, Huynh VA, Kencana AP, Sun ZL, Yang K. Master and slave transluminal endoscopic robot (MASTER) for natural orifice transluminal endoscopic surgery (NOTES). Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:1192-5. doi: 10.1109/IEMBS.2009.5333413.
citation: Phee SJ, Low SC, Sun ZL, Ho KY, Huang WM, Thant ZM. Robotic system for no-scar gastrointestinal surgery. Int J Med Robot. 2008 Mar;4(1):15-22. doi: 10.1002/rcs.179.
citation: Phee SJ, Ho KY, Lomanto D, Low SC, Huynh VA, Kencana AP, Yang K, Sun ZL, Chung SC. Natural orifice transgastric endoscopic wedge hepatic resection in an experimental model using an intuitively controlled master and slave transluminal endoscopic robot (MASTER). Surg Endosc. 2010 Sep;24(9):2293-8. doi: 10.1007/s00464-010-0955-8. Epub 2010 Feb 23.