NCT06452875

Brief Summary

Evaluate the outcomes of NKF as an initial method for biliary access.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

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

January 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

June 5, 2024

Last Update Submit

June 5, 2024

Conditions

Pancreatitis

Keywords

ERCPBiliary cannulationNeedle-knife fistulotomyStandard cannulation methods

Outcome Measures

Primary Outcomes (2)

  • Adverse events

    Comparison of adverse event rate between the two strategies

    30 days from the procedure

  • Technical success

    Comparison of technical success between the two strategies

    1 day (same day of the procedure)

Interventions

Primary Needle Knike FistulotomyPROCEDURE

After verifying the eligibility of the papillary morphology (excluding flat or diverticular papillae according to Viana's classification), access to the bile duct will be initiated using the primary needle knife fistulotomy technique. After the first contact of the needle knife with the papilla, the endoscopist will have a total of 8 minutes, after which he can change to other cannulation techniques (eg standard cannulation methods through the papillary orifice) or even stop the procedure. During ERCP all patients will be submitted to PEP prophylaxis with indomethacin. Also as a prophylactic PEP measure a pancreatic stent will be placed whenever there is cannulation or opacification of the Wirsung duct. For the purpose of this study, a dedicated form (attached) will be created with the various variables to be analyzed.

Eligibility Criteria

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

* ERCP with indication for biliary access * Naïve papilla (excluding flat or diverticular papillae according to Viana's classification)

You may qualify if:

  • ERCP with indication for biliary access
  • Naïve papilla

You may not qualify if:

  • Patients unable to sign or understand the informed consent
  • Patients with surgically altered anatomy
  • Patients with tumors of the papilla
  • Previous sphincterotomy
  • Spontaneous papillary fistula
  • Papilla not visualized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ULS Nordeste

Bragança, 5301-852, Portugal

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 11, 2024

Study Start

January 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations

PT(1)