NCT05385354

Brief Summary

The maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound at four different parts:

  • Pancreatic head
  • Pancreatic neck
  • Pancreatic body
  • Pancreatic tail

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

2.4 years

First QC Date

May 6, 2022

Last Update Submit

November 7, 2024

Conditions

Pancreatic Duct Dilatation

Outcome Measures

Primary Outcomes (1)

  • Maximal diameter of main pancreatic duct in millimeters

    Measurements of main pancreatic duct at different sections of the pancreas

    The measurement is performed once during endosonography.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing EUS for investigation of non-pancratic disease (e.g. subeptithelial tumor of the upper GI-tract

You may qualify if:

  • Patients undergoing EUS for investigation of non-pancratic disease (e.g. subeptithelial tumor of the upper GI-tract
  • Indication for EUS is undependent from the study
  • Written informed consent
  • Age ≥18 years

You may not qualify if:

  • Pancreatic diseases (chronic or acute pancreatitis, pancreatic tumor, pancreatic cyst, etc.)
  • Disorders of papilla duodeni major/minor (adenoma/carcinoma of papilla duodeni major or minor)
  • Biliary disorders (bile duct stones, cholangio carcinoma, cholangitis)
  • Elevated Bilirubin and/or Lipase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic and Policlinik of Internal Medicine II

Munich, Bavaria, 81675, Germany

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physician, head of clinical pancreatology

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 23, 2022

Study Start

May 3, 2022

Primary Completion

September 15, 2024

Study Completion

October 30, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Locations

DE(1)