Efficacy, Safety and Recurrence After Cold-EMR Plus APC for Large Colonic Lesions

NCT06435377 | Not Yet Recruiting

• 1 other identifier: Cold-EMR plus APC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.

Conditions

Colonic Disease

Outcome Measures

Primary Outcomes (2)

• Residual

  Evaluation of residual in the biopsy of the defect after the cold-EMR. The specimen will be evaluated independently from the polyp sample.

  1 day

• Recurrence

  The recurrence rate of adenomas at the site of any qualifying, previously resected lesions is measured after 3-6 and 12 months.

  1 year

Secondary Outcomes (5)

• Efficacy of procedure

  1 day

• Rate of delayed bleeding of the patient

  1 day

• Rate of post-polipectomy syndrome

  1 day

• perforation

  1 day

• Time

  1 day

Interventions

Procedure: Cold EMR + APC PROCEDURE

* Initial submucosal injection of saline solution and methylene blue, followed by 'piece-meal' resection using a dedicated cold snare * Biopsy of the resection bed * Ablation of the defect using argon plasma coagulation (APC).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects will be evaluated for post-procedural pain (using a VAS scale) and need for pain-killers. As part of the standard care, the patient will receive a 30-day post procedure follow-up phone call or an ambulatory evaluation will be arranged 30-days after the endoscopic procedure, to discuss the histologic results and schedule a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the post procedural pain in the first four weeks after treatment, the need for pain-killers and, should these occur, the adverse events (included fever, hematochezia, need for hospital admission). The rate of recurrence will be calculated by endoscopic visualization of the EMR site at the follow-up (T1:3-6 months; T2 11-13Months) using endoscopic magnification and electronic chromoendoscopy.

You may qualify if:

• All patients aged ≧ 18 years undergoing colonoscopy for any indication (screening, anemia, surveillance, or scheduled to undergo endoscopic mucosal resection)
• Lesions of 20 mm and larger.
• All colonic lesions removed using COLD-EMR technique, presenting both adenomatous (Kudo IIIL/IIIS pit pattern)
• Patients who were able to provide written informed consent

You may not qualify if:

• Suspected lesions for submucosal invasion (e.g., Kudo V or Paris 0-IIa-IIc with non-granular surface)
• Lesions with a wide Paris 0-Is component (\>10mm) that could increase the risk of submucosal invasion and could limit the mechanical cutting of the snare
• Pedunculated polyps
• Active/quiescent colitis
• Rectal lesions
• Residual or recurrent adenoma after endoscopic mucosal resection

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

IT (1)