A comparative study to verify the usefulness and safety of endoscopic sphincterotomy using (OptimosTM) and foreign-made sphincter incision (CleverCut3V)

An open, randomized, multicenter, prospective comparative study to verify the usefulness and safety of endoscopic sphincterotomy using modified sphincterotome (OptimosTM) and foreign-made sphincterotome (CleverCut3V)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006201

Enrollment

104

Registered

2021-05-28

Start date

2021-04-12

Completion date

Unknown

Last updated

2021-06-24

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

Conditions

None listed

Interventions

Medical Device : In this study, two intervention groups were randomly assigned according to the type of sphincterotome used.

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

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

Secondary

Measure	Time 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 Ill Jang

Yonsei University Health System, Gangnam Severance Hospital

aerojsi88@gmail.com+82-2-2019-3580

Outcome results