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PRIMARY NEEDLE KNIFE FISTULOTOMY

NCT06452875 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-06-11

No results posted yet for this study

Summary

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

Conditions

Interventions

PROCEDURE

Primary Needle Knike Fistulotomy

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.

Sponsors & Collaborators

  • University of Minho

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06452875 on ClinicalTrials.gov