Endoscopic Submucosal Dissection (ESD)- Master Slave Robotic System - Human Study
Condition: Endoscopic Submucosal Dissection
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to evaluate the feasibility, ease and safety of flexible
      endoscopic robotic system to treat early gastric cancer in humans.
    

Detailed description: 
      Aim:

      To evaluate the feasibility and safety of Endoscopic Submucosal Dissection (ESD) using Master
      Slave Endoscopic Robotic System in humans.

      Material and Methods:

      To assess the feasibility and safety of ESD in humans, 3 patients with early gastric cancer
      or sessile polyp in the stomach with no evidence of involvement of deeper layer will be
      included in the study. The depth of involvement is evaluated by endoscopic ultrasound. An
      informed consent about the nature of the procedure, complications and the need for surgery
      will be explained to the patient. The master slave robot system (Human master robotic
      interface, telesurgical workstation and slave manipulator) and forward viewing therapeutic
      endoscope with 2 operating channels (GIF -2T160) will be used. The master controller controls
      the slave manipulator with electrical cables through a software interface. The slave
      manipulator in turn controls the end effectors (Monopolar 'L' hook and grasper) through
      cables passed through the two operating channels of the endoscope. The master slave robot
      system will be set up by the engineers from the Nanyang Technological University, Singapore.
      The endoscope will be connected to the high definition visual display and will be recorded
      throughout the procedure. Another high definition monitor will be set up for the
      surgeon/endoscopist who will control the MASTER at the console and the movements at the
      console will be continuously recorded. Monopolar electrocautery (ERBE) will be set up and
      tested. The settings for cutting and blend will be the same as used in the conventional ESD.

      The therapeutic endoscope and the end effectors will be sterilised by immersing the scope in
      glutaraldehyde for 30 minutes before the procedure.

      Patient will be kept fasting for 8 hours before the procedure. Under IV sedation, with the
      patient in left lateral position, end viewing diagnostic gastroscope is passed with an
      overtube. The lesion will be identified. Then the lesion will be marked by electrocautery
      (ERBE) all around. Then Gelofusine® (containing 4% succinylated gelatin, sodium hydroxide)
      stained with methylene blue will be injected submucosally under the lesion to create a
      cushion for ESD. Then IT knife is used for the mucosal cut all around the lesion. The double
      channel endoscope (GIF 2T160) will be exchanged through the overtube for the conventional
      endoscope after checking the system. Then submucosal dissection of the lesion will be
      performed, using the Master.

      The data will be captured in the standard proforma for each patient. The endoscopic view and
      the external view of the MASTER will be recorded throughout the procedure.

      Analysis - Efficacy and Safety outcomes:

      The ease of the procedure (grasping, retraction, triangulation and complete excision), time
      required for mucosal cutting and submucosal dissection and completeness of the procedure will
      be analysed. Safety outcomes include intraoperative, immediate postoperative complications
      (bleeding, perforation) and the need for laparotomy will be assessed. Delayed Complications
      if any will be recorded for up to 30 days after the procedure.

      Statistical Methodology:

      As this is a pilot study, no sample size calculation was done. The aim is to perform the
      procedure in 3 subjects. Descriptive statistics will be used to describe safety data.
    

Intervention name(s): ESD using Master Slave Robotic System
Intervention type(s): Device
Intervention description(s): Endoscopic submucosal dissection of early gastric cancer or broad sessile polyp using Master Slave Robotic System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endoscopic Submucosal Dissection; ESD; EMR; Early Gastric Cancer; Flexible Endoscopic Robotic System; Master Slave Robot; Ease & Safety of ESD by Flexible Master Slave Robotic System