Colorectal Polyp
Conditions
Brief summary
Endoscopic mucosal resection (EMR) is an effective and has been widely used technique for the treatment of superficial colorectal neoplasms. Although, conventional EMR (CEMR) showed high efficacy for the management of colorectal superficial neoplasms, there is problematic limitation in this technique - incomplete resection. In literature, the anchoring-tip EMR (AEMR), named as Tip-in EMR was first introduced in 2016 from Japan. Recently, several retrospective studies have been suggested about the effectiveness of AEMR. However, there has been no prospective randomized controlled study to identify its advantage over CEMR. Therefore, the investigators performed a multicenter randomized controlled trial to estimate the effectiveness of AEMR compared with CEMR for the endoscopic treatment of intermediate-size (10 to 20 mm) colorectal polyps.
Detailed description
After injection of normal saline solution mix, snaring was tried for CEMR. In AEMR, the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins. At the final step of both conventional and Tip-in EMR, the lesion was resected.
Interventions
PROCEDUREAnchoring-tip vs. Conventional
Anchoring-tip: the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins. At the final step of both conventional and Tip-in EMR, the lesion was resected. Conventional: After injection of normal saline solution mix, snaring was tried for polyp resection.
Sponsors
Kyungpook National University Chilgok Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Intermediate-size (10 to 20 mm) colorectal polyps * Morphologically sessile (Is), slightly elevated (IIa), flat (IIb), and slightly depressed (IIc) as Paris classification of superficial neoplastic lesions * Laterally spreading tumor (granular and nongranular type) as Kudo classification.
Exclusion criteria
* Pedunculated or excavated/ulcerated polyps * Polyps with features strongly suggestive of submucosal invasive carcinoma * Polyps in patients with inflammatory bowel disease, familial polyposis, electrolyte abnormality, and coagulopathy * Residual lesions after endoscopic resection or presence of severe submucosal fibrosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome was comparing the R0 resection rate between Anchoring-tip EMR and Conventional EMR. | From EMR to reporting of histopathology, 1 month | Histopathologic complete resection (R0) was defined as en bloc resection and clear lateral and vertical resection margins. |
Countries
South Korea
Contacts
Primary ContactJoon Seop Lee, M.D., Ph.D.
Outcome results
None listed