"Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis.

Not Applicable

Completed

• Conditions: Colo-rectal Polyps
• Interventions: Procedure: "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)

• Registration Number: NCT03756636
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

All procedures are performed in the investigator's outpatient gastroenterology and digestive endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower intestinal tract.

Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion the lumen will be completely decompressed with aspiration of the gas, and then again relaxed with the instillation of only water. The EleviewTM will be injected into the submucosa in such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic evidence of complete resection. All the removed material will be stored and sent to histological analysis. Tolerability score will be recorded during the procedure.

Any "bleeding" (both intra- and post-procedural), perforation, post-polypectomy syndrome, stenosis or death in the 6 months following the procedure will be born "complication".

A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months after the procedure

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2018-11-26
• Study Completion: 2018-11-26
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Status Verified: 2019-09
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age> 18 years.
• Signing of informed consent.
• Possibility of being subjected to the diagnostic and therapeutic procedures of the study.
• Presence of colo-rectal polypoid lesions ≥ 15mm presenting macroscopic aspects of fibrosis as a consequence of previous incomplete treatments or biopsies or relapses after previous removal.

Exclusion Criteria

• Highly indicative morphological characteristics of carcinoma with submucosal invasion (Ulceration, Pit Pattern Vn according to Kudo et al.18)
• Pregnancy or breastfeeding
• ASA> 3
• Unstable personality or unable to adhere to the protocol procedures.
• Inability to provide informed consent.
• Injury not reachable endoscopically.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
"Underwater" mucosectomy	"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)	"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)

Primary Outcome Measures

Name	Time	Method
Macroscopically complete resection rate	6 Months
6-month recurrence rate;	6 Months
Rate of adverse events (according to the lexiconA ASGE).	6 Months

Trial Locations

Locations (1)

Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital; 🇮🇹 Rozzano, Milano, Italy