N/A
Completed N=151
Study of Forceps Cannulation During ERCP
Post-ERCP Acute Pancreatitis
Source: ClinicalTrials.gov NCT05336630 ↗
Enrolled (actual)
151
Serious AEs
9.3%
Results posted
Oct 2025
Primary outcomePrimary: Cannulation Success Rate and Difficult Cannulation Rate — 70; 68; 0; 13 Participants
Summary
A difficult cannulation has been identified as one of the high risk factors for developing post-ERCP pancreatitis (PEP). The accessibility and morphology of the papilla influence the level of cannulation difficulty. The use of a forceps to assist in the cannulation is a demonstrated effective technique for cannulating papillae that are difficult to access. Thus, the objective of our study is to determine whether a forceps assisted cannulation leads to less difficult cannulation during ERCP. Because difficult cannulation is associated with increased risk of PEP, our study investigates whether the forceps assisted cannulation also reduces the incidence of PEP as a secondary outcome. Eligible patients who have consented will either be randomized to cannulation with forceps or cannulation with no forceps.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cannulation Success Rate and Difficult Cannulation Rate |
70; 68; 0; 13 | — |
| SECONDARY Number of Post-ERCP Pancreatitis (PEP) |
4; 3 | — |
Eligibility Criteria
Inclusion Criteria
PRIMARY INCLUSION CRITERIA:
- Patient consent
- ERCP done on native papilla
SECONDARY INCLUSION CRITERIA:
- Papilla in a diverticulum
- Papilla on rim of a diverticulum
- Difficult cannulation (5 attempts, 5 minutes, or 2 unintended PD wire passages)
- Redundant tissue overlying papilla
- Type 2, 3, or 4 papilla
Exclusion Criteria
- Prior ampullectomy
- Known pregnancy, positive test, breastfeeding
- Clinical contraindication to ERCP
- Metal allergy
- Prior sphincterotomy
- Inability to follow protocol
- <18 years old
- Enrolled in another ERCP study
- Biliary/PD stent in place
Data sourced from ClinicalTrials.gov (NCT05336630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.