Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorTexas Tech University Health Sciences Center, El Paso

About this trial

Diagnostic modalities for the evaluation of small bowel pathology include video capsule endoscopy (VCE), antegrade and retrograde device-assisted enteroscopy, CT and MR enterography (1). Despite VCE being the first-line evaluation modality, it lacks interventional capability. Deep enteroscopy (DE) allows tissue sampling and other therapeutic interventions with real-time endoscopic assessment. DE is usually performed with specific endoscopes (balloon-assisted device or spiral overtube) making it time consuming and there is limited availability since special instruments and accessories are required.(1,2) The through-the-scope (TTS) balloon system consists of a balloon catheter designed for anchoring in the small bowel, inserted through the instrument channel of a standard colonoscope.(3) The catheter is advanced, the balloon is inflated and anchored in the small intestine and the endoscope slides over the guiding catheter to the inflated balloon. The most common indications for DE are obscure GI bleeding, iron deficiency anemia, abnormal capsule endoscopy and chronic diarrhea. As compared to spiral, single-or double-balloon enteroscopy, TTS (NaviAid, SMART Medical Systems Ltd, Ra'anana, Israel) is a simpler technique, which requires less investment in infrastructure. The balloon catheter is advanced blindly in front of a standard adult colonoscope as it bends around the curves of the small bowel. To prevent perforation/trauma the catheter is fitted with a soft silicone tip which easily bends under pressure.

Insertion depth can be calculated during the withdrawal of the enteroscope. The Aim of the study: To compare the depth of maximal ileal insertion between through-the-scope balloon enteroscopy (NaviAid) with enteroscopy using the adult colonoscope (Olympus CF-190) alone, in the same patient, in a prospective cohort at University Medical Center of El Paso, Texas.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign Informed Consent Form

Patients age between 18-90 years

Disqualifiers

Inability to sign Informed Consent Form

Pregnancy and breast feeding

Prior colon resection

Patients with known strictures

Trial population

Patients referred for evaluation of obscure gastrointestinal bleeding with nondiagnostic upper and lower endoscopy with suspicion of distal small bowel source based on either abnormal videocapsule endoscopy or imaging study

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

depth of maximal insertion into ileum

depth of insertion is measured on withdrawal of colonoscope by estimating in 10 cm intervals

Time frame
during the enteroscopy of the patient, about one hour

Secondary outcomes

1

diagnostic yield of retrograde enteroscopy

proportion of studies with significant findings on enterosocpy

Time frame
during the enteroscopy of the patient, bout one hour

Other outcomes

Sponsors and contacts

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