Endoscopic Treatment for Local Residual Neoplasia

NCT02386618 | Completed DMC

• 1 other identifier: DDC VN 07
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; laterally spreading tumors; endoscopic mucosal resestion; local residual neoplasia

Outcome Measures

Primary Outcomes (1)

• Efficacy of endoscopic treatment od local residual neoplasia (absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination)

  Efficacious endoscopic treatment is defined as absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination in 6 months after endoscopic treatment od local residual neoplasia.

  6 months

Study Arms (1)

Local residual neoplasia

OTHER

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

Procedure: Standardized endoscopic treatment of local residual neoplasia

Interventions

Standardized endoscopic treatment of local residual neoplasia 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

Local residual neoplasia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• incomplete endoscopic mucosal resection
• previous therapy for local residual neoplasia
• difficult or impossible localization of post-EMR scar

Sponsors & Collaborators

• Vitkovice Hospital: lead

Study Sites (1)

Vitkovice Hospital

Ostrava, 703 84, Czechia

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Premysl Falt, MD, PhD

  Vitkovice Hospital, Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MUDr. Premysl Falt

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: March 12, 2015
• Study Start: October 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

CZ (1)