Endoscopic Treatment for Local Residual Neoplasia

NCT ID: NCT02386618

Last Updated: 2015-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-06-30

Brief Summary

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Endoscopic mucosal resection (EMR) is considered to be a gold standard of therapy of colorectal lateral spreading tumors (LST) without significant risk for lymphatic spread. According to the investigators previous study, local residual neoplasia (LRN) after conventional endoscopic mucosal resection (EMR)occurs in up to 21% of cases. Endoscopic therapy of LRN was not sufficient in 53 % and has not been standardized yet.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Local residual neoplasia

Patients with local residual neoplasia in 3 months after endoscopic resection of colorectal lateral spreading tumors diagnosed endoscopically and/or histologically

Group Type OTHER

Standardized endoscopic treatment of local residual neoplasia

Intervention Type PROCEDURE

Endoscopic treatment will be performed according to the type of local residual neoplasia (LRN): A - endoscopically negative scar and neoplastic tissue found only in biopsy specimens - treatment by argon plasmacoagulation, B - endoscopically aparent LRN \< 5 mm - forceps biopsy + argon plasmacoagulation, C - endoscopically evident LRN \> 5 mm + lifting during submucosal injection - endoscopic mucosal resectio + argon plasmacoagulation, D - endoscopically evident LRN \> 5 mm + non-lifting during submucosal injection - endoscopic submucosal disection (ESD) or surgical resection

Interventions

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Standardized endoscopic treatment of local residual neoplasia

Endoscopic treatment will be performed according to the type of local residual neoplasia (LRN): A - endoscopically negative scar and neoplastic tissue found only in biopsy specimens - treatment by argon plasmacoagulation, B - endoscopically aparent LRN \< 5 mm - forceps biopsy + argon plasmacoagulation, C - endoscopically evident LRN \> 5 mm + lifting during submucosal injection - endoscopic mucosal resectio + argon plasmacoagulation, D - endoscopically evident LRN \> 5 mm + non-lifting during submucosal injection - endoscopic submucosal disection (ESD) or surgical resection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients older than 18 years
* patients with local residual neoplasia in scar in three months after endoscopic mucosal resection for laterally spreading tumor (0-IIa \> 10 mm)
* signed informed consent

Exclusion Criteria

* incomplete endoscopic mucosal resection
* previous therapy for local residual neoplasia
* difficult or impossible localization of post-EMR scar
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vitkovice Hospital

OTHER

Sponsor Role lead

Responsible Party

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Premysl Falt, M.D., Ph.D.

MUDr. Premysl Falt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Premysl Falt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vitkovice Hospital, Ostrava

Locations

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Vitkovice Hospital

Ostrava, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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DDC VN 07

Identifier Type: -

Identifier Source: org_study_id

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