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OpenTrials
Completed

NCT Number: NCT03654209

Post-resection Treatment of Large Colon Polyps

Patients who have provided informed consented and are scheduled to undergo endoscopic mucosal resection (EMR) of lesions 15mm and larger will be randomized to STSC (80 W, Effect 5) vs APC (preferred settings) vs No Treatment of the perimeter of the EMR site.

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Key information

Conditions

Recurrence Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sibley Memorial Hospital, Washington D.C., District of Columbia, United States

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About this study

Data regarding polyp morphology, location & shape will be recorded in addition to procedure and treatment length. Injection fluid use and clipping will also be recorded in addition to any procedural complications.

All randomized subjects will receive a 30-day post procedure follow-up phone call and be scheduled, as per the standard of care, to receive a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the rate of recurrence by endoscopic visualization of the EMR site at the first follow-up using endoscopic magnification and electronic chromoendoscopy, as well as systematic biopsy of the scars.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 25 years and older
  • Ability to provide informed consent
  • Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion

Exclusion criteria

  • Pedunculated lesions
  • Inflammatory bowel disease
  • Inability to provide informed consent
  • Lesions less than 15mm in largest dimension

Treatment and study plan

Argon plasma coagulation

Device

APC will be applied to the perimeter of the resection site

Snare Tip Soft Coagulation

Device

STSC will be applied to the perimeter of the resection site

Primary outcomes

  1. Recurrence

    Time frame: 1 day

    The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy

  2. Types of Recurrences

    Time frame: 1 day

    Description of whether recurrence was visible during the follow-up procedure and confirmed by pathology, visible during the follow-up procedure but not confirmed by pathology, or not visible during the follow-up procedure but confirmed by pathology of biopsies taken.

Secondary outcomes

  1. Time

    Time frame: 1 day

    The time it takes to apply each respective treatment (APC or STSC) on the day of procedure

  2. Complications

    Time frame: 1 day

    To look at the number of complications for each randomization arm as assessed through a 30 day follow-up period

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Erbe USA Incorporated

Registry information

Official study title

Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation or Argon Plasma Coagulation

Acronym: SAP

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 31, 2018
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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