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The evaluation of safety and efficacy of OptimosTM s sphincterotome in patient with biliary disease requiring endoscopic retrograde cholangiopancreatography

The evaluation of safety and efficacy of OptimosTM s sphincterotome in patient with biliary disease requiring endoscopic retrograde cholangiopancreatography : A multicenter prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0004995
Enrollment
200
Registered
2020-05-07
Start date
2020-05-11
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Yonsei University Health System, Gangnam Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with original biliary papilla 2. Patients with or suspected of having biliary tract disease 3. Patients in need of endoscopic retrograde cholangiopancreatography for treatment

Exclusion criteria

Exclusion criteria: 1.Under 19 2.Pregnant patients 3. Patients with reduced intelligence 4. Patients sensitive to contrast agents 5.Patients who had previously undergone papillary incision 6.Biliary papillary tumor patients 7.Patients who underwent hepatobiliary surgery 8.Patients who have difficulty endoscopically accessing the biliary papilla due to abdominal surgery (eg, gastrectomy, total gastrectomy)

Design outcomes

Primary

MeasureTime frame
Frequency and severity of complications (pancreatitis, bleeding, perforation, and infection) following papillary sphincter incision—

Secondary

MeasureTime frame
Success of biliary intubation by papillary sphincterotome, ease of biliary intubation, effectiveness of papillary incision, ease of contrast injection—

Countries

Korea, Republic of

Contacts

Public ContactSung Jang

Yonsei University Health System, Gangnam Severance Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026