The MOTOR-CD Trial

NCT05363930 | Completed DMC

• 1 other identifier: MCD 1; version:1.0
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Crohn's Disease

Keywords

Device-assisted enteroscopy; Single balloon enteroscopy; Novel motorized spiral enteroscopy; total enteroscopy

Outcome Measures

Primary Outcomes (1)

• Comparison of technical success with NMSE and SBE per patient [%]

  Percentage of participants in which anatomical region of interest is reached

  2 years

Secondary Outcomes (5)

• Comparison of diagnostic yield with NMSE and SBE per procedure [%]

  2 years

• Comparison of procedure time with NMSE and SBE[minutes]

  2 years

• Comparison of depth of maximal insertion with NMSE and SBE [centimetres]

  2 years

• Comparison of total enteroscopy rates with NMSE and SBE [percentage]

  2 years

• Comparison of adverse events with NMSE and SBE [percentage]

  2 years

Study Arms (2)

Single balloon enteroscopy

ACTIVE COMPARATOR

Patients with suspected Crohn's disease requiring small bowel enteroscopy based on clinical features, laboratory investigation and in cross-sectional imaging (computed tomography/magnetic resonance enterography or enteroclysis/ video capsule endoscopy

Device: Single balloon enteroscopy

Novel Motorized Spiral Enteroscopy

ACTIVE COMPARATOR

Patients with suspected Crohn's disease requiring small bowel enteroscopy based on clinical features, laboratory investigation and in cross-sectional imaging (computed tomography/magnetic resonance enterography or enteroclysis/ video capsule endoscopy

Device: Novel motorized spiral enteroscopy

Interventions

Novel motorized spiral enteroscopy DEVICE

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.

Novel Motorized Spiral Enteroscopy

Single balloon enteroscopy DEVICE

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.

Single balloon enteroscopy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspected of known IBD requiring small bowel endoscopy
• Ability to give a signed informed consent.
• Age ≥18 years -65 years -

You may not qualify if:

• Patient not fit for general anaesthesia
• Pediatric Patients (\<18 years)
• Pregnant or lactating mother
• Post operative cases
• Not willing to participate

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500008, India

Location

Related Publications (1)

• Pal P, Ramchandani M, Banerjee R, Viswakarma P, Singh AP, Reddy M, Rughwani H, Patel R, Sekaran A, Kanaganti S, Darisetty S, Nabi Z, Singh J, Gupta R, Lakhtakia S, Pradeep R, Venkat Rao G, Tandan M, Reddy DN. Technical performance and diagnostic yield of motorised spiral enteroscopy compared with single-balloon enteroscopy in suspected Crohn's disease: a randomised controlled, open-label study (the MOTOR-CD trial). Gut. 2023 Oct;72(10):1866-1874. doi: 10.1136/gutjnl-2023-329885. Epub 2023 May 17.

  PMID: 37197904 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Single-Balloon Enteroscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Balloon Enteroscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 6, 2022
• Study Start: May 7, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

IN (1)