Biliary 5Fr single pigtail stent placement for prevention of post-procedural cholangitis after endoscopic removal of biliary stones

Biliary 5Fr single pigtail stent placement for prevention of post-procedural cholangitis after endoscopic removal of biliary stones: A prospective randomized multicenter study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008544

Enrollment

302

Registered

2023-06-23

Start date

2023-07-03

Completion date

Unknown

Last updated

2023-06-26

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 : The test and control groups will be treated with the same endoscopic retrograde cholangiopancreatography (ERCP) and bile duct stone removal. After ERCP, a balloon-occluded cholangiog

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult, 19 years of age or older, who voluntarily consents to the study and signs an informed consent form. 2. Patients undergoing endoscopic retrograde cholangiopancreatography for the first time with a diagnosis of common bile duct stones on CT, MRI, US, or EUS. 3. One or more of the following high-risk groups for developing cholangitis after endoscopic retrograde cholangiopancreatography. - Mechanical lithotripsy - Multiple stones - Suppurative cholangitis 4. Willing to comply with treatments and procedures and return to the hospital for follow-up evaluations.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously performed endoscopic retrograde cholangiopancreatography. 2. Biliary stricture or bile duct cancer. 3. Common bile duct stones which have not been completely removed. 4. Surgically altered anatomy due to previous abdominal surgery. 5. Small bowel or large bowel strictures. 6. Patients who are pregnant. 7. Patients who, in the opinion of the investigator, are unable to complete the endoscopic procedure.

Design outcomes

Primary

Measure	Time frame
Incidence and severity of cholangitis after endoscopic retrograde cholangiopancreatography	—

Secondary

Measure	Time frame
Elevated liver function tests that worsen within 24-48 hours of endoscopic retrograde cholangiopancreatography;Rate of pancreatitis after endoscopic retrograde cholangiopancreatography;Stent Spontaneous Evacuation;Additional biliary drainage (endoscopic retrograde cholangiopancreatography or Percutaneous transhepatic biliary drainage);Admission period;Mortality	—

Countries

Korea, Republic of

Contacts

Public ContactEunae Cho

Chonnam National University Hospital

cea202@hanmail.net+82-62-220-6205

Outcome results