Not yet recruiting NCT06943417
Safety and Efficacy of Endoscopic Full Thickness Biopsy in Patients With Chronic Intestinal Pseudo-obstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Over the scope clip.
- Who it may be relevant to
- Registry conditions: Chronic Intestinal Pseudo-obstruction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy of Endoscopic Full Thickness Biopsy With Over the Scope Clip in Patients With Chronic Intestinal Pseudo-obstruction: A Single-Center, Single-Arm, Open-label, Interventional Trial
Overview
To evaluate the safety and efficacy of endoscopic full thickness biopsy for the diagnostic purpose of chronic intestinal pseudo-obstruction.
Interventions
- Device Over the scope clip
over the scope clip group
Primary outcome measures
- Percentage of total perforations (intraoperative and delayed perforations) [Time frame: Immediately after the intervention]
Secondary outcome measures (12)
- Intraoperative perforation rate [Time frame: Under procedure]
- Rate of delayed perforation [Time frame: Periprocedural]
- Intraoperative complications [Time frame: Under procedure]
- Intraoperative death rate [Time frame: Under procedure]
- Examination time [Time frame: Under procedure]
- Macroscopic specimen size [Time frame: Immediately after procedure]
- Findings of tissue specimens [Time frame: Immediately after procedure]
- Whether tissue evaluation is acceptable for biopsy purposes [Time frame: Immediately after procedure]
- Ratio of postoperative complications [Time frame: Immediately after procedure]
- Time or days of fluid intake postoperatively [Time frame: From date of procedure until the date of first fluid intake assessed up to 12 months]
- Time or number of days of food intake after procedure [Time frame: From date of procedure until the date of first food intake assessed up to 12 months]
- Length of hospital stay [Time frame: From date of procedure until the date of discharge assessed up to 12 months]
Eligibility criteria
Inclusion criteria
- Patients with chronic pseudo intestinal obstruction or suspected chronic pseudo intestinal obstruction
- Patients who are 18 years of age or older at the time of obtaining consent
- Gender: Any
Exclusion criteria
- Patients for whom it is difficult to perform endoscopy
- Patients who cannot obtain consent
- Patients with serious renal, hepatic, or cardiac disease
- Patients who are participating in other clinical research, except for observational research.
- Other patients whom the principal investigator or subinvestigator determines to be inappropriate to conduct this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Japan · 1 center
- International university health and welfare Narita hospital — Narita
Identifiers
NCT: NCT06943417 · 24-CN-021 · UMIN000057266