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The MOTOR-CD Trial

NCT05363930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-09-14

No results posted yet for this study

Summary

Both single-balloon enteroscopy (SBE) and novel motorized spiral enteroscopy (NMSE) are effective techniques for small bowel endoscopy in suspected Crohn's disease (CD). Small bowel endoscopy is indicated for confirming diagnosis when CD is suspected based on clinical features along with cross-sectional small bowel imaging (computed tomography enterography/enteroclysis: CTE or magnetic resonance enterography/enteroclysis: MRE) or capsule endoscopy (CE). It not only helps in diagnosing CD, but it also helps in excluding CD, diagnosing alternate conditions and taking a surgical decision if a tight stricture is found. The pilot study done by the investigators in 177 suspected CD patients (37.2% female, 7-75 years) undergoing total 201 device assisted enteroscopy (DAE) showed that NMSE scores over SBE with regards to small bowel evaluation with complete small bowel coverage and shorter procedure time. The investigators aim to validate this findings by comparing technical performance and diagnostic yield between NMSE (Olympus Medical, Tokyo, Japan) and SBE (Olympus Medical Systems Corporation, Tokyo, Japan) for small bowel evaluation. Additionally the investigators plan to compare depth of insertion, total enteroscopy rates, procedure time, adverse event rates between the two modalities.

To date, no study has compared both modalities in suspected Crohn's disease (CD) requiring small bowel evaluation in a randomized manner. Hence the investigators intend to perform a randomized controlled study based on these preliminary finding with appropriate matching and parallel study design in larger numbers.

Conditions

Interventions

DEVICE

Novel motorized spiral enteroscopy

Novel motorized spiral enteroscopy (Olympus Medical Systems Corporation, Tokyo, Japan) procedures would be performed under general anaesthesia with nasotracheal intubation under fluoroscopic guidance. Four litres of PEG was given to all patients with at least 8 hours of fasting prior to NMSE. Initially antegrade enteroscopy would be performed failing which retrograde enteroscopy would be done to reach the lesion. If the desired lesion is not reached via antegrade/retrograde route, hemoclips would be applied or tattooing would be done followed by enteroscopy from opposite direction on the same day under the same anesthesia using the same overtube. The time of procedure will be calculated from insertion of NMSE to its withdrawal. The depth of insertion would be measured by sequential withdrawal technique.

DEVICE

Single balloon enteroscopy

Single balloon enteroscopy will be performed with single balloon video-enteroscope (Olympus Medical Systems, Tokyo, Japan) under monitored anaesthesia (deep sedation with propofol). Initially antegrade/retrograde enteroscopy would be performed based on pre-procedure localization failing which enteroscopy would be done from opposite route to reach the lesion. Hemoclips would be applied or tattooing would be done followed by enteroscopy from opposite direction on the same day under the same anaesthesia using the same overtube. Duration of procedure would be calculated from the time of introduction of the enteroscope to time of removal. The depth of insertion would be measured using the push and pull technique.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-07
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05363930 on ClinicalTrials.gov