Small Bowel Disease Clinical Trial
— MOTOR-AIG-01Official title:
Novel Motorized Spiral Enteroscopy Vs Single Balloon Enteroscopy In Patients With Small Bowel Disorders- A Randomized Controlled Trial
Verified date | March 2023 |
Source | Asian Institute of Gastroenterology, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
STUDY OBJECTIVES: 1. Primary objective: Rate of total enteroscopy (TER) by means of NMSE or SBE with: Complete antegrade approach or combined antegrade and retrograde approach 2. Secondary objective: 1. Technical success of anterograde and retrograde approach 2. Procedural time (minutes) 3. Depth of maximum insertion (cm) 4. Diagnostic yield 5. Therapeutic success 6. Adverse events
Status | Completed |
Enrollment | 46 |
Est. completion date | December 15, 2022 |
Est. primary completion date | December 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Patients with small bowel disease with an indication for total enteroscopy with indeterminate imaging findings (as defined above) 2. Age > 18 years 3. Patients willing to give written consent Exclusion Criteria: 1. Positive imaging findings (as defined) 2. Age < 18 years. 3. Contraindications for endoscopy due to comorbidities 4. Unable to provide written informed consent 5. Patients with known severe GI tract inflammation, intestinal obstruction, gastroesophageal varices that preclude a safe enteroscopy procedure 6. Coagulopathy or thrombocytopenia that couldn't be corrected by blood product transfusion 7. Pregnant patients 8. Health status American Society of Anaesthetist Classification (ASA) >3 9. Inability to tolerate sedation or general anaesthesia for any reason 10. Pediatrics patients (infants and toddlers) 11. Eosinophilic esophagitis |
Country | Name | City | State |
---|---|---|---|
India | AIG Hospitals | Hyderabad | Telangana |
India | Hardik Rughwani | Hyderabad | Other |
Lead Sponsor | Collaborator |
---|---|
Asian Institute of Gastroenterology, India |
India,
Buscaglia JM, Dunbar KB, Okolo PI 3rd, Judah J, Akerman PA, Cantero D, Draganov PV. The spiral enteroscopy training initiative: results of a prospective study evaluating the Discovery SB overtube device during small bowel enteroscopy (with video). Endoscopy. 2009 Mar;41(3):194-9. doi: 10.1055/s-0028-1119602. Epub 2009 Mar 11. — View Citation
Ramchandani M, Rughwani H, Inavolu P, Singh AP, Tevethia HV, Jagtap N, Sekaran A, Kanakagiri H, Darishetty S, Reddy DN. Diagnostic yield and therapeutic impact of novel motorized spiral enteroscopy in small-bowel disorders: a single-center, real-world experience from a tertiary care hospital (with video). Gastrointest Endosc. 2021 Mar;93(3):616-626. doi: 10.1016/j.gie.2020.07.001. Epub 2020 Jul 12. — View Citation
Rondonotti E, Spada C, Adler S, May A, Despott EJ, Koulaouzidis A, Panter S, Domagk D, Fernandez-Urien I, Rahmi G, Riccioni ME, van Hooft JE, Hassan C, Pennazio M. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2018 Apr;50(4):423-446. doi: 10.1055/a-0576-0566. Epub 2018 Mar 14. — View Citation
Yamamoto H, Ogata H, Matsumoto T, Ohmiya N, Ohtsuka K, Watanabe K, Yano T, Matsui T, Higuchi K, Nakamura T, Fujimoto K. Clinical Practice Guideline for Enteroscopy. Dig Endosc. 2017 Jul;29(5):519-546. doi: 10.1111/den.12883. Epub 2017 Jun 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of total enteroscopy (TER) | Number of cases in which total small bowel examination can be performed | 1 year | |
Secondary | Technical success of anterograde and retrograde approach | For anterograde approach, crossing of duodenal-jejunal flexure and for retrograde approach, crossing of ileo-caecal valve- describes technical success | 1 year | |
Secondary | Procedural time (minutes) | Time taken for the entire procedure from start to end is procedural time | 1 year | |
Secondary | Depth of maximum insertion (cm) | The depth till which the small bowel examination can be done. The examination can be done till we reach the expected lesion or till the scope stops further movement in small intestines | 1 year | |
Secondary | Diagnostic yield | Diagnostic yield is defined as the percentage of procedures that can either confirm a diagnosis from previous studies or established a new definitive diagnosis at the anatomic location identified in previous studies or findings that could explain the clinical symptoms. | 1 year | |
Secondary | Therapeutic success | Therapeutic success is defined as successful endoscopic interventions such as for GI bleeding, polypectomy, and so on. | 1 year | |
Secondary | Adverse events | Adverse events are defined as minor or major. Minor adverse event was defined as superficial esophageal or colonic trauma, sore throat less than 72 hours in duration, abdominal discomfort lasting less than 48 hours, and mild nausea or vomiting not requiring hospital admission. Major adverse events were defined as perforation, significant bleeding requiring blood products, pancreatitis, or any hospital admission related to the procedure. | 1 year |
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