An interventional study of Anchoring-tip vs. Conventional in Colorectal Polyp, sponsored by Kyungpook National University Chilgok Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Kyungpook National University Chilgok Hospital · Not applicable, Interventional, and Treatment
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.
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.
385 studies on the registry are indexed under Polyps; 59 are open to participants now.
This study's planned enrollment of 200 is above the median of 160 across 250 interventional studies indexed under Polyps.
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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.
Procedure: Anchoring-tip vs. Conventional
After injection of normal saline solution mix, snaring was tried for CEMR.
Procedure: Anchoring-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.
Primary outcome was comparing the R0 resection rate between Anchoring-tip EMR and Conventional EMR.
Histopathologic complete resection (R0) was defined as en bloc resection and clear lateral and vertical resection margins.
Time frame: From EMR to reporting of histopathology, 1 month
Plan to share: No
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Kyungpook National University Chilgok Hospital