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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 (+/- 2) days after ercp

Awards & highlights

SOCCER Trial 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.Check my eligibility

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.See study design

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.

SOCCER Trial 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.

SOCCER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (during the ercp)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Difficult Cannulation

Secondary outcome measures

Number of Post-ERCP Pancreatitis (PEP)

SOCCER 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor

524 Previous Clinical Trials

2,543,187 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available in this clinical investigation?

"Correct. According to the details provided on clinicaltrials.gov, this ongoing medical trial was first posted on May 12th 2022 and is currently enrolling 152 participants from a single location."

Answered by AI

What is the current participation number for this experiment?

"Affirmative. Per the information present on clinicaltrials.gov, this medical trial was first posted on May 12th 2022 and is presently recruiting 152 subjects from a single site. The study has been edited recently, as of July 19th 2022."

Answered by AI

Recent research and studies

GutJournal

Acute Pancreatitis: The Substantial Human and Financial Costs

NEOPTOLEMOS, J P, M RARATY, M FINCH, and R SUTTON. 1998. “Acute Pancreatitis: The Substantial Human and Financial Costs”. Gut. BMJ. doi:10.1136/gut.42.6.886.

TrialsJournal

Correction To: Rectal Indomethacin Alone Versus Indomethacin and Prophylactic Pancreatic Stent Placement for Preventing Pancreatitis After ERCP: Study Protocol for a Randomized Controlled Trial

Elmunzer, B. Joseph, Jose Serrano, Amitabh Chak, Steven A. Edmundowicz, Georgios I. Papachristou, James M. Scheiman, Vikesh K. Singh, et al.. 2020. “Correction To: Rectal Indomethacin Alone Versus Indomethacin and Prophylactic Pancreatic Stent Placement for Preventing Pancreatitis After ERCP: Study Protocol for a Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-020-04458-0.

EndoscopyJournal

Papillary Cannulation and Sphincterotomy Techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline

Testoni, Pier, Alberto Mariani, Lars Aabakken, Marianna Arvanitakis, Erwan Bories, Guido Costamagna, Jacques Devière, et al.. 2016. “Papillary Cannulation and Sphincterotomy Techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline”. Endoscopy. Georg Thieme Verlag KG. doi:10.1055/s-0042-108641.

United European Gastroenterology JournalJournal