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Endoscopic Treatment for Local Residual Neoplasia

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ClinicalTrials.gov Identifier: NCT02386618
Recruitment Status : Completed
First Posted : March 12, 2015
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
Premysl Falt, M.D., Ph.D., Vitkovice Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Standardized endoscopic treatment of local residual neoplasia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Treatment for Local Residual Neoplasia After Endoscopic Mucosal Resection of the Colorectal Lateral Spreading Tumors (LST)
Study Start Date : October 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Local residual neoplasia
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
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




Primary Outcome Measures :
  1. Efficacy of endoscopic treatment od local residual neoplasia (absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination) [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386618


Locations
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Czech Republic
Vitkovice Hospital
Ostrava, Czech Republic, 703 84
Sponsors and Collaborators
Vitkovice Hospital
Investigators
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Principal Investigator: Premysl Falt, MD, PhD Vitkovice Hospital, Ostrava

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Responsible Party: Premysl Falt, M.D., Ph.D., MUDr. Premysl Falt, Vitkovice Hospital
ClinicalTrials.gov Identifier: NCT02386618     History of Changes
Other Study ID Numbers: DDC VN 07
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015

Keywords provided by Premysl Falt, M.D., Ph.D., Vitkovice Hospital:
colorectal cancer
laterally spreading tumors
endoscopic mucosal resestion
local residual neoplasia

Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases