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Endoscopic Submucosal Dissection (ESD)- Master Slave Robotic System - Human Study

This study has been completed.
Sponsor:
Collaborator:
Nanyang Technological University, Singapore
Information provided by (Responsible Party):
Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT01394861
First received: July 12, 2011
Last updated: March 4, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Endoscopic Submucosal Dissection
Device: ESD using Master Slave Robotic System
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Asian Institute of Gastroenterology, India:

Primary Outcome Measures:
  • Ease of the procedure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The ease of the procedure (grasping, retraction, triangulation), time required for mucosal cutting and submucosal dissection


Secondary Outcome Measures:
  • Completeness of the Procedure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Completeness of the procedure is evaluated during the procedure by endoscopy and gross examination of the resected specimen followed by histopathological examination.

  • Immediate Procedure Related Complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Bleeding or Perforation during and immediately after the procedure

  • Delayed Procedure Related Complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Any complications (Delayed Bleeding or Perforation) related to the procedure up to thirty days post procedure.


Enrollment: 3
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESD using MASTER Slave Robotic System Device: ESD using Master Slave Robotic System
Endoscopic submucosal dissection of early gastric cancer or broad sessile polyp using Master Slave Robotic System

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.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Early Gastric Cancer or Gastric sessile polyp with dysplasia

Exclusion Criteria:

  • Gastric Cancer with involvement of muscle layer
  • Advanced Gastric cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394861

Locations
India
Asian Institute Of Gastroenterology India
Hyderabad, Andhra Pradesh, India, 500082
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Nanyang Technological University, Singapore
Investigators
Principal Investigator: Nageshwar Reddy Duvvuru, MD, DM, DSc, FAMS, FRCP Asian Institute of Gastroenterology, India
Principal Investigator: Louis Soo Jay Phee, BEng, MEng, PhD Nanyang Technological University, Singapore
  More Information

No publications provided

Responsible Party: Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT01394861     History of Changes
Other Study ID Numbers: AIG-GI2011-04
Study First Received: July 12, 2011
Last Updated: March 4, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Asian Institute of Gastroenterology, India:
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

ClinicalTrials.gov processed this record on November 20, 2014