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Forceps

Forceps Cannulation During ERCP for Preventing Pancreatitis (SOCCER Trial)

N/A
Recruiting
Led By Timothy B Gardner, MD MS
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Redundant tissue overlying papilla
Type 2, 3, or 4 papilla
Must not have
Prior ampullectomy
<18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 (+/- 2) days after ercp
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating whether or not using a forceps to assist in cannulation during ERCP decreases the incidence of PEP.

Who is the study for?
This trial is for adults who need an ERCP (a procedure to examine the pancreatic and bile ducts) and have a difficult-to-access papilla. They must consent to participate, not be pregnant or breastfeeding, have no metal allergies, not be in another ERCP study, and have no prior surgeries on their bile duct opening.
What is being tested?
The study is testing if using forceps during ERCP makes cannulation (inserting a tube into the papilla) easier and reduces the risk of pancreatitis after the procedure. Participants will be randomly assigned to either undergo cannulation with forceps assistance or without it.
What are the potential side effects?
Potential side effects may include discomfort at the site of cannulation, bleeding, infection, or pancreatitis related to ERCP procedures. The use of forceps might also cause additional risks such as tissue injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have extra tissue over my nipple area.
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My condition involves type 2, 3, or 4 papilla.
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I have had an ERCP procedure on my original bile duct opening.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery to remove a tumor from the ampulla of Vater.
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I am under 18 years old.
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I have had a sphincterotomy surgery before.
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I cannot undergo ERCP due to health risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (during the ercp)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (during the ercp) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Difficult Cannulation
Secondary study objectives
Number of Post-ERCP Pancreatitis (PEP)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Forceps Assisted CannulationExperimental Treatment1 Intervention
Patients will have a forceps assisted cannulation during their ERCPs.
Group II: No Forceps Assisted CannulationActive Control1 Intervention
Patients will not have a forceps assisted cannulation during their ERCPs.

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
537 Previous Clinical Trials
2,539,901 Total Patients Enrolled
1 Trials studying Acute Pancreatitis
40 Patients Enrolled for Acute Pancreatitis
Timothy B Gardner, MD MSPrincipal InvestigatorDartmouth-Hitchcock Medical Center

Media Library

Forceps Cannulation (Forceps) Clinical Trial Eligibility Overview. Trial Name: NCT05336630 — N/A
Acute Pancreatitis Research Study Groups: No Forceps Assisted Cannulation, Forceps Assisted Cannulation
Acute Pancreatitis Clinical Trial 2023: Forceps Cannulation Highlights & Side Effects. Trial Name: NCT05336630 — N/A
Forceps Cannulation (Forceps) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05336630 — N/A
~18 spots leftby Apr 2025
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