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CompletedNCT02386618Updated Oct 6, 2015

Endoscopic Treatment for Local Residual Neoplasia

An interventional study of Standardized endoscopic treatment of local residual neoplasia in Colorectal Cancer, sponsored by Vitkovice Hospital. Completed at 1 site in Czech Republic. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-06.

Sponsored by Vitkovice Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • colorectal cancer
  • laterally spreading tumors
  • endoscopic mucosal resestion
  • local residual neoplasia
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 25 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Vitkovice Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Other
    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

Interventions

  • ProcedureStandardized 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

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What researchers measure

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.

    Time frame: 6 months

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Study locations

1 site
  • Vitkovice Hospital
    Ostrava, 703 84, Czech Republic
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02386618
Lead sponsor
Vitkovice Hospital
Responsible party
Premysl Falt, M.D., Ph.D. (MUDr. Premysl Falt, Vitkovice Hospital) — Principal investigator
First posted
Mar 12, 2015
Start date
Oct 2013
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Oct 6, 2015

Study contacts

Premysl Falt, MD, PhD
principal investigator · Vitkovice Hospital, Ostrava

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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