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A prospective cohort to assess patient's tolerability for endoscopic therapy of Barrett's esphagus


- candidate number28353
- NTR NumberNTR6906
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-dec-2017
- Secondary IDs1001 W15.100
- Public TitleA prospective cohort to assess patient's tolerability for endoscopic therapy of Barrett's esphagus
- Scientific TitleThe Post-Procedural pain after Endoscopic Therapy for Barrett's esohagus cohort: a continuous, prospective registration on patient's tolerability.
- ACRONYMP-PET cohort
- hypothesis
- Healt Condition(s) or Problem(s) studiedEndoscopic treatment, Barrett's neoplasia, Barrett's esophagus, Radiofrequency ablation, Cryoablation, Endoscopic resection, Endoscopic mucosa resection
- Inclusion criteriaAll patients (all age, both sexes) undergoing endoscopic therapy for Barrett's esophagus, that consent to complete a 14-days digital diary post-procedure
- Exclusion criteriaNo access to e-mail
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-mrt-2016
- planned closingdate1-mrt-2021
- Target number of participants200
- InterventionsPatients receive a 14 days digital diary to assess retrosternal pain (range 0-10), dysphagia (range 0-4) and use of analgesics (yes/no, type).
- Primary outcomeCumulative pain through 14 days, defined as the area under the curve for a pain versus time (14 days) plot
- Secondary outcomeCumulative dysphagia, cumulative use of analgesics, peak pain score, duration of pain
- TimepointsTreatment endoscopy; 14 days digital diary; follow-up endoscopy
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S.N. van Munster
- CONTACT for SCIENTIFIC QUERIES S.N. van Munster
- Sponsor/Initiator St. Antonius Hospital, University Medical Center Utrecht (UMCU), Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryThis is a continuous, prospective registration that includes all patients undergoing endoscopic therapy for Barrett's esophagus as part of regular clinical care. The addition of this study, includes a 14 days digital diary that will be sent to all patients to assess pain, dysphagia and use of pain killers. The need for IRB approval was waived by the IRB of the MEC-U.
- Main changes (audit trail)
- RECORD17-dec-2017 - 4-jan-2018


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