Initial use of Rotatable sphincterotome facilitates selective bile duct cannulation compared with use of conventional sphincterotome: a prospective randomized controlled trial of papillotome.

Initial use of Rotatable sphincterotome facilitates selective bile duct cannulation compared with use of conventional sphincterotome: a prospective randomized controlled trial of papillotome. - Cannulation Study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018032

Enrollment

200

Registered

2015-08-01

Start date

2016-01-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Of all diseases needed to perform ERC.

Interventions

Rotatable shincterotome Conventional sphincterotome

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. In patients with native papilla.

Exclusion criteria

Exclusion criteria: 1. In patients with ECOG Perfoemance Status Grade 4. 2. In patients with impaired consciousness. 3. In patients with suspected pancreatobiliary maljunction. 4. In patients with previous gastrectomy with Billroth II or Roux-en-Y reconstruction. 5. In patients with acute pancreatitis 6. In patients with impacted stone or tumor of ampulla of Vater. 7. In patients with bilioduodenal fistula opening around the papilla

Design outcomes

Primary

Measure	Time frame
The primary endpoint is successful selective bile duct cannulation within 10 miniutes and 10 times after randomization.	—

Secondary

Measure	Time frame
The secondary endpoints are successful final selective bile duct cannulation rates, procedure success rate, selective bile duct cannulation time, number of attempts at bile duct cannulation, number of accidental pancreatic duct insertions, procedure time, radiation exposure time, use of precutting for selective bile duct cannulation, and complications including PEP rates in the randomized patients and also in the initially enrolled cohort.	—

Measure

Time frame

The secondary endpoints are successful final selective bile duct cannulation rates, procedure success rate, selective bile duct cannulation time, number of attempts at bile duct cannulation, number of accidental pancreatic duct insertions, procedure time, radiation exposure time, use of precutting for selective bile duct cannulation, and complications including PEP rates in the randomized patients and also in the initially enrolled cohort.

—

Countries

Japan

Contacts

Public ContactAkira Kurita

Kitano Hospital, The Tazuke Kofukai Medical Research Institute Division of Gastroenterology and Hepatology, Digestive Disease Center

kuritaaki1976@gmail.com06-6312-8831

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026