Chronic Intestinal Pseudo-obstruction
Conditions
Keywords
Chronic intestinal pseudo-obstruction, Endoscopic full thickness biopsy
Brief summary
To evaluate the safety and efficacy of endoscopic full thickness biopsy for the diagnostic purpose of chronic intestinal pseudo-obstruction.
Interventions
DEVICEOver the scope clip
over the scope clip group
Sponsors
International University of Health and Welfare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of total perforations (intraoperative and delayed perforations) | Immediately after the intervention | Percentage of total perforations (intraoperative and delayed perforations) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of delayed perforation | Periprocedural | Rate of delayed perforation |
| Intraoperative complications | Under procedure | Intraoperative complications |
| Intraoperative death rate | Under procedure | Intraoperative death rate |
| Examination time | Under procedure | Examination time |
| Macroscopic specimen size | Immediately after procedure | Macroscopic specimen size |
| Intraoperative perforation rate | Under procedure | Intraoperative perforation rate |
| Whether tissue evaluation is acceptable for biopsy purposes | Immediately after procedure | Whether tissue evaluation is acceptable for biopsy purposes |
| Ratio of postoperative complications | Immediately after procedure | Ratio of postoperative complications |
| Time or days of fluid intake postoperatively | From date of procedure until the date of first fluid intake assessed up to 12 months | Time or days of fluid intake postoperatively |
| Time or number of days of food intake after procedure | From date of procedure until the date of first food intake assessed up to 12 months | Time or number of days of food intake after procedure |
| Length of hospital stay | From date of procedure until the date of discharge assessed up to 12 months | Length of hospital stay |
| Findings of tissue specimens | Immediately after procedure | Findings of tissue specimens |
Countries
Japan
Contacts
Primary ContactTakaomi Kessoku, M.D., Ph.D.
Backup ContactYo Ishihara, M.D.
Outcome results
None listed