NCT01478919

Brief Summary

Laterally Spreading Tumors (LST) are important precursosrs of invasive colorectal cancer. Endoscopic treatment has replaced surgery in most of the cases. Nevertheless, after conventional Endoscopic Mucosal Resection (CER), Local Residual Neoplasia (LRN) is an issue. Therefore, endoscopic follow-up and treatment are necessary. To decrease its occurrence, the risk factors of LRN shoudl be identified. Thereafter, in high-risk patients, other modalities of initial treatment including Endoscopic Submucosal Dissection (ESD) and surgical treatment, could be considered. The purpose of this prospective study is to identify risk factors associated with the presence of LRN after CER of LSTs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

11 months

First QC Date

November 21, 2011

Last Update Submit

September 19, 2013

Conditions

Keywords

Endoscopic Mucosal ResectionLaterally Spreading TumorLocal Residual NeoplasiaColonoscopyTherapy

Outcome Measures

Primary Outcomes (1)

  • Occurence of Local Residual Neoplasia (LRN)

    LRN was defined as a histologically confirmed neoplastic tissue in the biopsy samples obtained from post-resection scar during follow-up colonoscopy 3 months after endoscopic resection

    3 months

Secondary Outcomes (1)

  • Evaluation of Selected Risk Factors for Local Residual Neoplasia (LRN)

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred for Endoscopic Mucosal Resection (EMR) of Laterally Spreading Tumors (LST.)

You may qualify if:

  • all consecutive patients referred for EMR of LST

You may not qualify if:

  • polyposis syndromes
  • previous therapeutic attempt

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vitkovice Hospital

Ostrava, 703 84, Czechia

Location

Related Publications (1)

  • Urban O, Kijonkova B, Kajzrlikova IM, Vitek P, Kliment M, Fojtik P, Falt P, Reiterova K, Horava V Jr. Local residual neoplasia after endoscopic treatment of laterally spreading tumors during 15 months of follow-up. Eur J Gastroenterol Hepatol. 2013 Jun;25(6):733-8. doi: 10.1097/MEG.0b013e32835eda96.

    PMID: 23442418BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 23, 2011

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

November 1, 2011

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations