Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06271941
Other study ID # HAPC-RCT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date April 1, 2028

Study information

Verified date June 2024
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Large (≥20mm) colorectal polyps often harbor areas of advanced neoplasia, making them immediate colorectal cancer (CRC) precursors. Such polyps have to be completely removed to prevent CRC and to avoid surgery and/or adjuvant therapy. The laterally spreading lesions (LSLs) are removed via endoscopic mucosal resection (EMR). However, recurrence is common. Recent studies have found that the use of hybrid argon plasma coagulation (h-APC) for the ablation of the margin and base of resection post-EMR could significantly reduce the recurrence rate, and complete closure of the post-EMR defect can prevent other adverse pre- and post-procedure outcomes such as bleeding. It is hypothesized that hypothesize that performing hybrid argon plasma coagulation (h-APC) margin and base ablation post-EMR for large (≥20mm) colorectal LSLs will demonstrate a lower recurrence rate compared to Snare Tip Soft Coagulation (STSC) margin ablation. It is also hypothesized that performing complete closure of the EMR defect will result in lower rates of adverse events compared to cases where no defect closure is performed.


Description:

This is a prospective, randomized controlled trial enrolling patients with non-pedunculated colorectal polyps ≥ 20mm who are referred for endoscopic mucosal resection (EMR). All primary EMRs will be randomized to either EMR with hybrid argon plasma coagulation (h-APC) ablation of the base and margins or EMR with Snare Tip Soft Coagulation (STSC) margin ablation groups. Additionally, each group will be randomized to either complete defect closure or not. Patients will be enrolled in the study before the endoscopy procedure, or in the outpatient clinic. Eligible patients who have consented to participate in the study will be asked to take a standard colonoscopy preparation regimen before their scheduled procedure. EMR intervention will be performed for all eligible patients with a large laterally spreading lesions (LSLs) by expert endoscopists. Only if a polyp meets inclusion criteria, the study subject will be enrolled and randomized into one of these four groups: - Group 1: EMR + h-APC margin and base thermal ablation - Group 2: EMR + STSC of the margin The standard EMR technique will be used for the primary removal of all polyps. Submucosal injection will be used to lift the polyp from the muscularis propria. Injection will be used as per the current standard of care using a contrast agent and a lifting agent (e.g., NaCl 0.9% or Voluven). Snare electrocautery resection will be facilitated until complete visible removal of the complete polyp. Electrocautery snare technique will be facilitated using standard microprocessor-controlled electrocautery. If residual polyp tissue cannot be removed by a snare, other means such as cold snare (i.e., for small residual polyp tissue that cannot be engaged into standard snares) or avulsive methods will be used. After the complete removal of the polyp, depending on the randomization group, h-APC or STSC techniques will be used for margin and base or only margin ablation of the post-EMR defect. The polypectomy site will be tattooed with submucosal injection of approximately 1-2cc of India ink (standard of care to mark lesions) to allow recognition of the polypectomy site during follow-up endoscopy. Polyps will be sent to the pathology lab and evaluated according to standard practice by institutional pathologists. To determine the homogeneity and depth of h-APC margin ablation in the pathology lab, some ablated margins might be resected using the standard cold snare technique. Telephone calls at 20-30 days following the EMR will be conducted to assess possible adverse events. Follow-up 1: Surveillance colonoscopy at 6 months (± 2 months) after the EMR intervention for the assessment of recurrence (biopsy from the post-EMR site to be confirmed by pathology) following the intervention (h-APC) and the control (STSC) techniques. Follow-up 2: Surveillance colonoscopy at 18 months (± 2 months) after the EMR intervention for the assessment of recurrence (biopsy from the post-EMR site to be confirmed by pathology) at FU1. Patients with visible recurrence at the EMR site will undergo additional resection for complete eradication of recurrence. Patients with no visible but pathology-confirmed recurrence will be rescheduled for another colonoscopy with subsequent treatment of the post-EMR site and another follow-up colonoscopy for biopsies and confirmation of complete/incomplete eradication within 18 months after the initial EMR.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 892
Est. completion date April 1, 2028
Est. primary completion date October 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult =18 years old - patients undergoing EMR for a large (=20mm) colorectal LSL - patients providing written and informed consent for study participation. Exclusion Criteria: - inflammatory bowel disease; - non-elective colonoscopy; - poor general health (American Society of Anesthesiologists classification >III); - coagulopathy or thrombocytopenia (international normalized ratio =1.5 or platelets <50 x 109/L); - pedunculated polyps (Paris class Ip, Isp); - overt signs of deep submucosal invasive cancer (JNET 3); - biopsy proven invasive carcinoma in a potential study polyp.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hybrid Argon Plasma Coagulation (h-APC)
The hybrid argon plasma coagulation (h-APC) combines an ablation technique (APC) with the option for submucosal saline injection using a high-pressure water jet. The technique allows for the lifting of dysplastic epithelium, creating a cushion under the mucosa to facilitate the ablation of larger areas more thoroughly and with higher energy settings, while posing a low risk for side effects or complications.
Snare tip soft coagulation (STSC)
The Snare tip soft coagulation (STSC) involves using a snare to remove polyps, while simultaneously applying soft coagulation to the surrounding tissue using a specialized tip on the snare.

Locations

Country Name City State
Canada Centre Hospitalier de l'Université de Montréal Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Clinically significant delayed bleeding after EMR with STSC or h-APC Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention. 30 days
Other Clinically significant delayed bleeding in the proximal colon after EMR with STSC or h-APC Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention. Proximal defined as proximal to the splenic flexure. 30 days
Other Delayed perforation after EMR with STSC or h-APC Delayed perforation defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract 30 days
Other Factors associated with recurrence after colorectal EMR between the h-APC and STSC methods Lesion recurrence at first follow-up after EMR of large (=20mm) colorectal LSLs when performing STSC margin ablation or h-APC margin and base ablation. Defined by pathology-confirmed hyperplastic, serrated or adenomatous histology of the same histology of the index lesion at the tattooed resection site on at least one of four random biopsies of resection scars. Factors such as age, sex, lesion size (20-29mm, =30mm; 20-39mm, =40mm), histology, location, difficulty (difficult defined as peri-appendiceal, on the ileocecal valve, resection previously attempted and failed by a referring endoscopist), use of epinephrine in submucosal injection, submucosal lifting solution, resection type (en bloc [i.e. in one piece] vs piecemeal), technical success, study site, endoscopist yearly EMR volume, presence of intraprocedural bleeding, utilization of adjunct resection methods, ileocecal or anus involvement, polyp histology/morphology will be evaluated. 4 years
Other Factors associated with adverse event rates after EMR with STSC or h-APC Adverse event rates after EMR of large (=20mm) colorectal LSLs when performing EMR with STSC margin ablation or h-APC margin and base ablation. Defined as either a) delayed bleeding (defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention) or b) delayed perforation (defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract). Factors such as age, sex, lesion size, morphology, histology, location, complete/incomplete/no defect closure, prophylactic vessel ablation, base ablation, anticoagulant use will be evaluated 30 days
Primary Recurrence after colorectal EMR between the h-APC and STSC methods Lesion recurrence at first follow-up after EMR of large (=20mm) colorectal LSLs when performing STSC margin ablation or h-APC margin and base ablation. Defined by visual recurrence or pathology-confirmed hyperplastic, serrated or adenomatous histology of the same histology of the index lesion at the tattooed resection site on at least one of four random biopsies of resection scars. These will be evaluated from an intention to treat and per protocol standpoint. 4 years
Secondary Adverse event rates after EMR with STSC or h-APC Adverse event rates after EMR of large (=20mm) colorectal LSLs when performing EMR with STSC margin ablation or h-APC margin and base ablation. Defined as either a) delayed bleeding (defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention) or b) delayed perforation (defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract). These will be evaluated from an intention to treat and per protocol standpoint. 4 years
Secondary Technical success of STSC or h-APC Technical success of STSC or h-APC defined as achieving a complete uninterrupted ring ofcircumferential margin ablation for STSC and h-APC, without crossover to complete the margin ablation, and achieving 100% surface ablation of the resection base for h-APC. 4 years
Secondary Lesion recurrence at the 18-month follow-up after EMR with STSC or h-APC Lesion recurrence at the 18-month follow-up after EMR with STSC or h-APC 4 years
Secondary High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period. High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period at the resection site. 4 years
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT00098787 - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05425940 - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Phase 3
Suspended NCT04595604 - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. N/A
Completed NCT03414125 - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening N/A
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT03874026 - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Completed NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Recruiting NCT05568420 - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting NCT02972541 - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer N/A
Completed NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A