Hybrid APC Assisted EMR for Large Colon Polyps
Condition: Colon Polyp; Colon Adenoma; Colon Cancer
MeSH terms: Adenoma; Polyps; Colonic Polyps
Study type: Interventional

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.
    

Intervention name(s): Hybrid APC
Intervention type(s): Device
Intervention description(s): Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.
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)
Primary purpose: Treatment
Keywords: Colon polyp; EMR; Hybrid-APC; Laterally spreading tumor