Study of Forceps Cannulation During ERCP

NCT05336630 | Completed Results FDA Device

• 1 other identifier: STUDY02001449
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-ERCP Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Cannulation Success Rate and Difficult Cannulation Rate

  A difficult cannulation will be defined as any cannulation that results in any of the following: 5 or more minutes, 5 or more cannulation attempts, or 2 or more unintentional pancreatic wire passages.

  Baseline (during the ERCP)

Secondary Outcomes (1)

• Number of Post-ERCP Pancreatitis (PEP)

  5 (+/- 2) days after ERCP

Study Arms (2)

Forceps Assisted Cannulation

EXPERIMENTAL

Patients will have a forceps assisted cannulation during their ERCPs.

Device: Forceps

No Forceps Assisted Cannulation

NO INTERVENTION

Patients will not have a forceps assisted cannulation during their ERCPs.

Interventions

Forceps DEVICE

The forceps clears the redundant tissue to enable access to the papilla, as well as stabilizes the ampullary position to permit an easier cannulation. The forceps is an FDA approved instrument and does not put the patient at any higher risk for any adverse event. Please note that for the explicit purpose of the study the forceps will be used to grab tissue and not take biopsies. The forceps may still be used to take biopsies if the physician believes it is indicated.

Forceps Assisted Cannulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient consent
• ERCP done on native papilla
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Health

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (14)

• Thaker AM, Mosko JD, Berzin TM. Post-endoscopic retrograde cholangiopancreatography pancreatitis. Gastroenterol Rep (Oxf). 2015 Feb;3(1):32-40. doi: 10.1093/gastro/gou083. Epub 2014 Nov 17.

  PMID: 25406464 BACKGROUND

• Neoptolemos JP, Raraty M, Finch M, Sutton R. Acute pancreatitis: the substantial human and financial costs. Gut. 1998 Jun;42(6):886-91. doi: 10.1136/gut.42.6.886.

  PMID: 9691932 BACKGROUND

• Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.

  PMID: 8782497 BACKGROUND

• Elmunzer BJ, Serrano J, Chak A, Edmundowicz SA, Papachristou GI, Scheiman JM, Singh VK, Varadarajulu S, Vargo JJ, Willingham FF, Baron TH, Cote GA, Romagnuolo J, Wood-Williams A, Depue EK, Spitzer RL, Spino C, Foster LD, Durkalski V; SVI study group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE). 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. 2020 Jun 3;21(1):471. doi: 10.1186/s13063-020-04458-0.

  PMID: 32493506 BACKGROUND

• Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc. 2004 Jun;59(7):845-64. doi: 10.1016/s0016-5107(04)00353-0. No abstract available.

  PMID: 15173799 BACKGROUND

• Halttunen J, Meisner S, Aabakken L, Arnelo U, Gronroos J, Hauge T, Kleveland PM, Nordblad Schmidt P, Saarela A, Swahn F, Toth E, Mustonen H, Lohr JM. Difficult cannulation as defined by a prospective study of the Scandinavian Association for Digestive Endoscopy (SADE) in 907 ERCPs. Scand J Gastroenterol. 2014 Jun;49(6):752-8. doi: 10.3109/00365521.2014.894120. Epub 2014 Mar 14.

  PMID: 24628493 BACKGROUND

• Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.

  PMID: 27299638 BACKGROUND

• Haraldsson E, Kylanpaa L, Gronroos J, Saarela A, Toth E, Qvigstad G, Hult M, Lindstrom O, Laine S, Karjula H, Hauge T, Sadik R, Arnelo U. Macroscopic appearance of the major duodenal papilla influences bile duct cannulation: a prospective multicenter study by the Scandinavian Association for Digestive Endoscopy Study Group for ERCP. Gastrointest Endosc. 2019 Dec;90(6):957-963. doi: 10.1016/j.gie.2019.07.014. Epub 2019 Jul 18.

  PMID: 31326385 BACKGROUND

• Haraldsson E, Lundell L, Swahn F, Enochsson L, Lohr JM, Arnelo U; Scandinavian Association for Digestive Endoscopy (SADE) Study Group of Endoscopic Retrograde Cholangio-Pancreaticography. Endoscopic classification of the papilla of Vater. Results of an inter- and intraobserver agreement study. United European Gastroenterol J. 2017 Jun;5(4):504-510. doi: 10.1177/2050640616674837. Epub 2016 Oct 17.

  PMID: 28588881 BACKGROUND

• Levenick JM, Gardner TB, Hussain ZH, Gordon SR. SpyBite-assisted biliary cannulation for intradiverticular papilla during ERCP. Endoscopy. 2014;46 Suppl 1 UCTN:E514. doi: 10.1055/s-0034-1377365. Epub 2014 Nov 19. No abstract available.

  PMID: 25409044 BACKGROUND

• Borahma M, Benelbarhdadi I, Berhili C, Lagdali N, Ajana FZ. Forceps-assisted technique: a new technique for difficult cannulation. Endoscopy. 2020 Jul;52(7):E247-E248. doi: 10.1055/a-1089-7418. Epub 2020 Jan 29. No abstract available.

  PMID: 31995819 BACKGROUND

• Murabayashi T. The forceps-assisted technique for difficult cannulation has been in widespread use since 1996. Endoscopy. 2021 Apr;53(4):457. doi: 10.1055/a-1288-0801. Epub 2021 Mar 29. No abstract available.

  PMID: 33780985 BACKGROUND

• Foster BR, Jensen KK, Bakis G, Shaaban AM, Coakley FV. Revised Atlanta Classification for Acute Pancreatitis: A Pictorial Essay. Radiographics. 2016 May-Jun;36(3):675-87. doi: 10.1148/rg.2016150097.

  PMID: 27163588 BACKGROUND

• Hadley SM Jr, Chevalier JI, Tomasetti GE, Hill JC, Duclos MC, Klibansky DA, Pohl H, Siegel CA, Toor A, Bensen SP, Adler JM, Gordon SR, Gardner TB. The Effectiveness of Forceps-Assisted Cannulation for Difficult Cannulation During Endoscopic Retrograde Cholangiopancreatography: Results of the SOCCER Randomized Controlled Trial. Am J Gastroenterol. 2025 May 14. doi: 10.14309/ajg.0000000000003531. Online ahead of print.

  PMID: 40367484 DERIVED

MeSH Terms

Interventions

Surgical Instruments

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Limitations and Caveats

ERCP procedure and postprocedure decisions were at the discretion of the attending endoscopist based on clinically appropriate guidelines. Another potential limitation is that the study did not account for multiple unintended biliary wire cannulations when the intent was PD wire cannulation. The results may not be as generalizable to endoscopists who are not as skilled with and comfortable using the forceps through the endoscope.

Results Point of Contact

• Title: Dr. Timothy B. Gardner
• Organization: Dartmouth-Hitchcock Medical Center

timothy.b.gardner@hitchcock.org

603-653-9033

Study Officials

• Timothy B Gardner, MD MS

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be unblinded to their treatment on the 5 (+/- 2) day follow-up call.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Staff Physician, Gastroenterology & Hepatology

Model Details: Patients will be randomized to either ERCP with forceps assisted cannulation or ERCP with no forceps.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 20, 2022
• Study Start: May 12, 2022
• Primary Completion: October 15, 2024
• Study Completion: October 21, 2024
• Last Updated: October 30, 2025
• Results First Posted: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)