Prospective randomized comparison of EMR versus EMR followed by photodynamic therapy for the treatment of early barrett's cancer.

Prospective randomized comparison of EMR versus EMR followed by photodynamic therapy for the treatment of early barrett's cancer. - P-BEC study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31690

Enrollment

Registered

2008-04-23

Start date

2008-06-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's cancer

Interventions

PDT: patients are given the photosensitizer 5-aminolevulinic acid at a dosage of 40 mg/kg. Subsequently PDT is performed with a dye-laser, tuned at a wavelength of 633 nm. The light is delivered to

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients age >= 18 years treated for high-grade intraepithelial dysplasia and/or mucosal cancer with EMR, in whom follow-up biopsies do not show remaining severe neoplasia or malignancy

Exclusion criteria

Exclusion criteria: * Patients unable or unwilling to give informed consent * Coagulopathy uncorrected at the time of endoscopy or thrombocytopenia (

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study will be the recurrence rate of histological proven severe dysplasia or cancer after EMR or EMR and PDT.	—

Secondary

Measure	Time frame
·Complication rates of PDT: Complications are subdivided into procedural (during PDT) and post procedural complications (after ending the procedure). Complications are further subdivided into major and minor complications. ·Mortality rates within 30 days of intervention.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)