Pilot study for the evaluation of different sampling techniques guided by single-operator cholangioscopy in patients with indeterminate biliary strictures

Pilot study for the evaluation of different sampling techniques guided by single-operator cholangioscopy in patients with indeterminate biliary strictures - SAMPCHOL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035804

Enrollment

120

Registered

2026-06-23

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

K83.1

Interventions

Group 1: Study Objective The primary objective of this prospective randomized pilot study is to identify the optimal SOC-guided tissue acquisition technique using designated biopsy forceps for the dia

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: indeterminate biliary stricture, indication für ERCP with cholangioscopy

Exclusion criteria

Exclusion criteria: Patients with visible pancreatic head mass lesions (susp.pancreatic cancer), altered pancreatobiliary or duodenal anatomy (postoperative and others), contraindication to ERCP, evidence for intrahepatic metastases, septic cholangitis

Design outcomes

Primary

Measure	Time frame
Diagnostic sensitivity of biopsies	—

Secondary

Measure	Time frame
Diagnostic specificity, accuracy, adequacy. Cut-off value for number of samples for accurate diagnosis, time of sampling/cholangioscopy, laboratory parameters, Post-ERCP pancreatitis, bleeding, cholangitis, perforation	—

Countries

Germany

Contacts

Public ContactMark Ellrichmann

Universitätsklinikum Schleswig-Holstein, Campus Kiel

mark.ellrichmann@uksh.de+4943150022371

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026