Utility of Motorized Spiral Enteroscopy for Suspected Small Bowel Pathology

NCT04152239 | Terminated

• 1 other identifier: MSE SB study
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnosis and treatment of small bowel pathologies remain challenging due to the long length of the small bowel. Obscure gastrointestinal (GI) bleeding with negative upper and lower GI workup, suspected inflammatory bowel disease, and suspected tumors of the small bowel often require small bowel investigation. While video capsule endoscopy (VCE) and computed tomography (CT) enteroclysis (CTE) are often the initial diagnostic modalities for suspected small bowel pathologies and can provide structural information of the small bowel mucosa, biopsy or therapy for the detected pathology could not be performed with VCE or CTE. In patients who require biopsy or therapy of the detected small bowel pathology, deep enteroscopy would be the procedure of choice in modern clinical practice before subjecting patient to surgery. Diagnostic and therapeutic deep enteroscopy can be performed by balloon overtube assisted enteroscopy (eg, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) or spiral overtube assisted enteroscopy (SE). Despite the difference in equipment design of DBE, SBE, and SE, the concepts for small bowel intubation by pleating the intestine over the endoscope are the same behind these techniques. Depending on the location of the small bowel pathology reported by VCE or CTE, antegrade (oral route), retrograde (anal route), or combined antegrade and retrograde deep enteroscopy for total enteroscopy can be performed.

Conditions

Small Bowel Disease

Keywords

enteroscopy

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  Diagnostic yield: defined as successful identification of the suspected pathology based on clinical presentation, pre-MSE small bowel imaging or capsule endoscopy

  peri-procedure

Secondary Outcomes (6)

• Technical success

  peri-procedure

• Therapeutic yield

  peri-procedure

• Insertion time

  peri-procedure

• Maximal depth of insertion in small bowel

  peri-procedure

• Rate of total enteroscopy

  peri-procedure

Study Arms (1)

Study group

Study group includes consecutive patients with suspected small bowel pathology based on clinical presentation, small bowel imaging or capsule endoscopy indicated for diagnostic and/or therapeutic enteroscopy. Patients fulfilling the inclusion criteria and without exclusion criteria would undergo MSE per study protocol.

Procedure: Motorized spiral enteroscopy (MSE)

Interventions

Motorized spiral enteroscopy (MSE) PROCEDURE

Endoscopic Procedures MSE is a 1.6m enteroscope equipped with a single-use short spiral overtube propelled by a user-controlled motor contained in the handle of the endoscope. The endoscopist controls the left-right and up-down movements by the usual manuvers while the forward or backward advancement of the enteroscope would be contolled by a foot pedal that activates the spiral overtube rotation. Antegrade MSE, retrograde MSE, or combined antegrade and retrograde MSE would be performed as clinically indicated for diagnostic +/- therapeutic procedures.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with suspected small bowel pathology indicated for deep enteroscopy for diagnostic +/- therapeutic procedure.

You may qualify if:

• Age ≥ 18 years
• Patients with suspected small bowel pathology based on clinical presentation, small bowel imaging or capsule endoscopy indicated for diagnostic and/or therapeutic enteroscopy
• Written informed consent available

You may not qualify if:

• Contraindications for endoscopy due to comorbidities
• Unable to provide written informed consent
• Patients with known severe GI tract inflammation, intestinal obstruction, gastroesophageal varices that preclude a safe enteroscopy procedure
• Coagulopathy or thrombocytopenia that cannot be corrected by blood product transfusion
• Pregnant patients
• Moribund patients from terminal illnesses

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

Study Officials

• Raymond Tang, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professional Consultant

Study Record Dates

• First Submitted: November 2, 2019
• First Posted: November 5, 2019
• Study Start: October 22, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

HK (1)