Colorectal Cancer
Conditions
Keywords
Endoscopic Mucosal Resection (EMR), Endoscopic submucosal dissection (ESD), Laterally spreading tumors (LST)
Brief summary
Colorectal cancer is one of the leading causes of cancer-related mortality worldwide. Early-stage non-polypoid neoplastic lesions, particularly Laterally Spreading Tumors - Granular Type (LST-G) larger than 20mm, require effective endoscopic removal to prevent malignant progression. The two primary techniques for resecting these lesions are Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD). EMR is a widely used, minimally invasive technique that involves resecting the lesion with a diathermic snare after submucosal injection. While effective and safe, EMR often necessitates piecemeal resection, increasing the risk of local recurrence. In contrast, ESD, developed in Asia, allows for en bloc resection regardless of lesion size, ensuring more accurate histopathological assessment and lower recurrence rates. However, ESD requires greater technical expertise, has longer procedural times, and carries a higher risk of complications. In Western clinical practice, EMR remains the standard treatment, whereas ESD is selectively performed in high-expertise centers. Given the lack of randomized controlled trials comparing EMR and ESD in Western populations, this study aims to provide robust clinical evidence to guide treatment decisions. The primary objective of this study is to compare the recurrence/residual adenomatous tissue rate at 6 and 12 months between EMR and ESD in patients with LST-G lesions of the colon and rectum
Interventions
PROCEDUREEndoscopic Mucosal Resection (EMR)
atients assigned to this arm will undergo Endoscopic Mucosal Resection (EMR), a standard endoscopic technique that involves the resection of colorectal Laterally Spreading Tumors - Granular type (LST-G) using a diathermic snare with submucosal injection. The procedure may be performed en bloc or in a piecemeal fashion, depending on lesion size and characteristics. EMR is widely accepted for lesions with low submucosal invasion risk but has a higher recurrence rate than ESD.
Patients assigned to this arm will undergo Endoscopic Submucosal Dissection (ESD), an advanced endoscopic technique that allows for en bloc resection of large colorectal Laterally Spreading Tumors - Granular type (LST-G). The procedure involves the use of specialized knives to dissect the submucosal layer, ensuring complete resection with histologically clear margins (R0 resection). ESD has been associated with lower recurrence rates but requires a high level of expertise, longer procedural times, and carries a higher risk of complications.
Sponsors
Azienda USL Reggio Emilia - IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Diagnosis of Laterally Spreading Tumor - Granular Type (LST-G) ≥ 20 mm in the colon or rectum with an indication for endoscopic resection. * Life expectancy \> 10 years. * Ability to understand and sign the informed consent form, demonstrating comprehension of the study and willingness to participate.
Exclusion criteria
* Diagnosis of Laterally Spreading Tumor - Non-Granular Type (LST-NG). * Presence of depressed areas within the lesion. * Lesions located on a scar or anastomosis site. * Lesions classified as Kudo Vi or Vn pattern. * History of chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease). * Diagnosis of hereditary polyposis syndromes (e.g., familial adenomatous polyposis, Lynch syndrome).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence/Adenomatous Residual Rate | 6 and 12 months after treatment | Proportion of patients with local recurrence or residual adenomatous tissue, confirmed through follow-up colonoscopies and histopathological examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Resection Rate | 6 and 12 months after treatment | Proportion of patients with a complete histopathological resection (R0), defined as tumor-free margins in both lateral and deep resection edges, out of the total number of randomized patients |
| Differences in Procedure Time | Up to 2 months | Comparison of the average duration of the procedure (from submucosal injection to complete lesion resection) between the EMR and ESD groups. The procedure time is measured intraoperatively and is calculated as the total duration from the initial submucosal injection to the completion of lesion resection. |
| Bleeding Rate | During procedure (up to 2 months from enrollment) and 24 hours and 3 months after treatment | Number of patients experiencing bleeding out of the total number of randomized patients. |
| Perforation Rate | During procedure (up to 2 months from enrollment) and 24 hours and 3 months after treatment | Number of patients with an intraoperative perforation, defined as visible mesenteric fat or free peritoneal space during the procedure, or delayed perforation diagnosed based on symptoms (abdominal pain, fever, peritonitis) and confirmed by radiological imaging (free air, fluid collection). |
| Overall Complication Rate | 24 hours after treatment | Proportion of patients experiencing at least one complication, classified according to the Accordion Severity Classification of Postoperative Complications. |
Countries
Italy
Contacts
CONTACTLucarini Matteo, MD
PRINCIPAL_INVESTIGATORSassatelli Romano, MD
Azienda USL - IRCCS di Reggio Emilia
Outcome results
None listed