Registry for Advanced Endoscopy

NCT05187312 | Recruiting

• 1 other identifier: 2021-7616
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Observational registry including endoscopic diagnostic and therapeutic interventions in the gastrointestinal tract

Conditions

Cholangiocarcinoma; Pancreatic Cancer; Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Incidence of Adverse events following endoscopic procedures. Measured as percentage of individuals with an adverse event

  30-days and 60-days post-procedure

• Diagnostic yield

  Diagnostic yield after tissue sampling

  1-year follow up

Interventions

Endoscopic retrograde Cholangio- pancreatography PROCEDURE

Endoscopic intervention in the biliary or pancreatic duct

Endoscopic ultrasound PROCEDURE

Endoscopic investigation/intervention with ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for endoscopic procedures at Karolinska University Hospital

You may qualify if:

• Clinical indication for endoscopic intervention/procedure

You may not qualify if:

• No informed consent
• Age \<18 years

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 18146, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma, bile, tissue samples

MeSH Terms

Conditions

Cholangiocarcinoma; Pancreatic Neoplasms; Cholangitis, Sclerosing

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Cholangitis; Bile Duct Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Erik von Seth, MD, PhD

  Region Stockholm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik von Seth, MD, PhD

CONTACT

+46812380000; erik.von.seth@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2021
• First Posted: January 11, 2022
• Study Start: January 14, 2022
• Primary Completion (Estimated): January 14, 2032
• Study Completion (Estimated): January 14, 2032
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)