Novel Motorized Spiral Enteroscopy Vs Single Balloon Enteroscopy In Patients With Small Bowel Disorders- A RCT
Condition: Small Bowel Disease
MeSH terms: Intestinal Diseases
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      1. INTRODUCTION: Small-bowel (SB) disorders remain a diagnostic and therapeutic challenge
           for endoscopists because of its unfavourable anatomy for endoscopy. It is difficult to
           perform deep enteroscopy of the long redundant lengthy small intestine by the bare
           endoscope, most of the time operator end up in pushing the SB rather than traveling
           through it. Last two decades saw a paradigm shift in the management of SB disorders with
           the introduction of deep enteroscopy1-4, including Double-balloon enteroscopy (DBE,
           Fujifilm, Tokyo, Japan), Single-balloon enteroscopy5 (SBE, Olympus Medical Systems
           Corporation, Tokyo, Japan), and Spiral enteroscopy6 (SE, Spiral Medical, LCC, USA). The
           DBE and SBE techniques have had varied results as far as depth of insertion is
           concerned; moreover, both are time-consuming and have difficult ergonomics for the
           endoscopist which are a major limiting factor. Spiral enteroscopy (SE)6 was introduced
           in 2007, which was two-operator technique where a spiral-shaped over-tube (Discovery
           Small Bowel, DSB) was used to pleat the small bowel over the enteroscope by manual
           rotation of the over tube. Deep endoscopic access to the small bowel with all available
           methods is still a complex, cumbersome, time-consuming procedure, and requires high
           endoscopic skills. Novel Motorized Spiral Enteroscope7 (NMSE, Olympus Medical, Tokyo,
           Japan) is a recent advancement in the field of enteroscopy. This enteroscope works on
           the same principle as that of SE and comes with an integrated user controlled motor in
           the handle of the enteroscope. The integrated electric motor is controlled with the help
           of a footswitch for rotating a short spiral over tube to pleat and un-pleat the small
           bowel. This would increase the possibility to accelerate the procedure, facilitate
           insertion, and simplify the technique with a single operator. The procedure can be done
           both by antegrade and retrograde approaches. Data is scarce on the utility, safety and
           efficacy of Novel Motorized Spiral Enteroscopy (NMSE) for evaluation in patients with
           suspected SBD by both the routes of examination. Also there are no comparative studies
           between SBE and NMSE. Hence we have planned a Randomized controlled trial to compare
           both modalities.

        2. RATIONALE: SBE is the standard procedure used for small bowel examination at our center.
           SBE in prior studies has shown diagnostic yield of 40-60%5 but very low TER (0-22%)4,10,
           with long procedure time. NMSE on the other hand has the advantage of greater TER and
           high diagnostic yield with shorter procedure times and minimal adverse events. Our study
           on NMSE11 has shown high diagnostic yield of 70%, with TER of 61% and total procedure
           time of around 40min. Various studies have shown the safety and efficacy of SBE and
           NMSE. One recent prospective study by Beyna9 et al. using NMSE for only antegrade
           enteroscopy showed total enteroscopy rate (TER) of 10.6% (14/132) with technical success
           of 97%. Majority of patients (74.2%) underwent NMSE for suspected GI bleeding. Overall
           diagnostic yield was 74.2% and endotherapy was done in 68.2% patients. In our study11 on
           NMSE, recently published, we have shown comparable technical success using both
           antegrade (92.85%) and retrograde (100%) routes. There was higher total enteroscopy rate
           of 60.6% with antegrade route showing 31.1%.This real-world scenario analysis showed
           that diagnostic yield of NMSE was 70% in those who successfully underwent enteroscopy
           and therapeutic procedures were done in almost one fourth of patients. Till date, there
           are no comparative data between NMSE and Balloon assisted enteroscopy techniques. Hence,
           we aim to compare NMSE and SBE in Randomized controlled trial.

        3. STUDY METHODS / STUDY PROCEDURE / METHODS OF ASSESSMENT: Patients presenting with
           symptoms and signs suggestive of small bowel disorders will be admitted and investigated
           as per the latest guidelines2. Patients satisfying the inclusion and exclusion criteria
           will be randomized in one of the two arms and will undergo either NMSE or SBE. As per
           the presentation and indication patients in both arms will undergo antegrade or
           retrograde enteroscopy. Patients undergoing antegrade enteroscopy will also undergo
           retrograde enteroscopy if indicated in the same sitting with the aim of total
           enteroscopy. Patients will be managed according to the findings and will be discharged
           as per the conditions. Patients will be followed up in the OPD or telephonically 1 week
           and after 1 month of discharge.
    

Intervention name(s): Novel Motorized Spiral Enteroscopy
Intervention type(s): Device
Intervention description(s): This study involves performance of spiral enteroscopy in one arm and single balloon enteroscopy in the other arm in patients who satisfy inclusion criteria
Other intervention name(s): Single Balloon Enteroscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Small bowel disease; IBD; Single balloon enteroscopy; spiral enteroscopy