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Hybrid APC Assisted EMR for Large Colon Polyps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03390907
Recruitment Status : Active, not recruiting
First Posted : January 4, 2018
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
John M. Levenick, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE December 29, 2017
First Posted Date  ICMJE January 4, 2018
Last Update Posted Date September 22, 2020
Actual Study Start Date  ICMJE September 28, 2018
Estimated Primary Completion Date November 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
Percentage of complete resection [ Time Frame: 6 months post initial procedure ]
The primary outcome of interest will be the percentage of complete resection at 6 months.
Original Primary Outcome Measures  ICMJE
 (submitted: December 29, 2017)
Percentage of complete resection [ Time Frame: 6 months post initial procedure ]
The primary out come of interest will be the percentage of complete resection at 6 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
Measure of within 30 days of procedure adverse events ( post-polypectomy bleeding and post-polypectomy syndrome) [ Time Frame: 30 days ]
The secondary outcome of interest will be measure of major adverse event rate, mainly post-polypectomy bleeding and post-polypectomy syndrome
Original Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2017)
Measure of within 30 days of procedure adverse events ( post-polypectomy bleeding and post-polypectomy syndrome) [ Time Frame: 30 days ]
The secondary outcome of interest will be measure of major adverse event, mainly post-polypectomy bleeding and post-polypectomy syndrome
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hybrid APC Assisted EMR for Large Colon Polyps
Official Title  ICMJE Hybrid APC Assisted EMR for Large Colon Polyps to Reduce Local Recurrence : A Prospective Data Collection Study
Brief Summary The purpose of this study to evaluate and examine whether use of Hybrid Argon Plasma Coagulation (APC) as an adjunct to endoscopic mucosal resection (EMR) will reduce the risk of residual or recurrent neoplasia at 6 months. Hybrid APC is an existing FDA approved device used to assist with ablation of abnormal tissue anywhere in the GI tract.
Detailed Description

Colon Cancer is a major disease that effects more than 1 million people per year globally. Adenomatous polyps have been identified as the main precursor leading to colorectal cancer. Colon cancer screening is the best way to detect and remove large, often asymptomatic polyps. Early detection and resection of these colorectal polyps can prevent the development of colon cancer. Endoscopic mucosal resection (EMR) is a technique used for resection of medium to large colon polyps. In this technique, fluid is injected into the submucosa creating a cushion between the mucosa and the muscularis propria. An electrocautery snare is then deployed to resect the polyp in a single (en-bloc) or multiple (piecemeal) pieces. Most polyps >2 cm are resected in piecemeal way. Although EMR is now considered standard of care with a successful resection rate of 85 % and low risk of complication (3-10% bleeding and 1% perforation), this technique has inherent deficiencies, especially piecemeal EMR. Recurrence rates following piecemeal EMR can be as high as 20%. Resection of scarred polyps using this technique is particularly challenging due to the non-lifting of the polyp. Endoscopic submucosal dissection (ESD) is an alternative approach that aims to remove non- pedunculated precancerous or cancerous lesions over 20 mm in one piece (en-bloc resection rate of 89.95% and lesion recurrence rate of 0.7%). However, due to its technical complexity and high complication risk (mainly bleeding and perforation, with complication rates approximately 8%), it is not the current standard of care and only performed by experts in the technique.

Hybrid Argon plasma coagulation (APC) is a new technique in which the endoscopist reinjects the submucosa with fluid to create a cushion (normal saline/ diluted adrenaline and /or sodium hyaluronate solution) to protect the muscle layer and then ablation is done using spray argon coagulation to treat any microscopic residual disease that is the seed for local recurrence. Previous studies have shown that this technique is a safe and easily applicable technique to complete resection for recurrent polyps after first EMR.

Investigators hypothesize that with Hybrid APC assisted EMR there will be a decrease in recurrence rate after 6 months and it will be more effective compared to the standard EMR procedure.

This is a pilot study in which patients with non-pedunculated large polyps ≥ 20mm undergoing endoscopic mucosal resection (EMR) will be recruited. Following standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease. Resected polyps will be sent to the pathology laboratory where pathologist determine the final diagnosis of the polyps as per standard of care.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a pilot study design in which patients with non-pedunculated large polyps ≥ 20mm undergoing EMR will be recruited. Following standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation (APC) of the base edges of the polypectomy site to fulgurate any potential microscopic residual disease.
Masking: None (Open Label)
Masking Description:
Following Standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.
Primary Purpose: Treatment
Condition  ICMJE
  • Colon Polyp
  • Colon Adenoma
  • Colon Cancer
Intervention  ICMJE Device: Hybrid APC
Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.
Study Arms  ICMJE Experimental: Hybrid APC
Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract.
Intervention: Device: Hybrid APC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 18, 2019)
41
Original Estimated Enrollment  ICMJE
 (submitted: December 29, 2017)
40
Estimated Study Completion Date  ICMJE November 3, 2020
Estimated Primary Completion Date November 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patient aged ≥18 and ≤89 of any gender, ethnicity and race referred to endoscopy for resection of large colon polyps
  • Patients with a ≥20mm colon non-pedunculated polyp
  • Ability to give written informed consent

Exclusion Criteria:

  • Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
  • Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
  • Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
  • Patients with inflammatory bowel disease
  • Patients who are receiving an emergency colonoscopy
  • Poor general health (ASA class>3)
  • Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
  • Poor bowel preparation
  • Target sign or perforation during initial EMR
  • Need for ESD for complete resection prior to APC
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03390907
Other Study ID Numbers  ICMJE STUDY00008877
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John M. Levenick, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Levenick, MD Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP