Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial

NCT04559867 | Suspended

• 1 other identifier: 6029074
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 1

Brief Summary

Participants in this study will be undergoing a procedure called an endoscopic retrograde cholangiopancreatography (ERCP). This procedure is most commonly performed to help treat conditions affecting specific areas of the digestive system called the pancreas and bile ducts. Patients will consent to allow the study physician to access these areas of the digestive system by either making a cut called a needle-knife fistulotomy or a sphincterotomy.

Conditions

Cholangiopancreatography, Endoscopic Retrograde; Biliary Tract Diseases

Keywords

Needle Knife Fistulotomy; Sphincterotomy; Post-ERCP pancreatitis

Outcome Measures

Primary Outcomes (1)

• Post-ERCP pancreatitis

  The primary objective to be examined is the incidence of post-ERCP pancreatitis.

  Up to 7 days

Secondary Outcomes (7)

• Cannulation Success Rate

  Day 0

• Inspection Time

  Day 0

• Time to successful cannulation

  Day 0

• Total procedure time

  Day 0

• Ampullary morphology

  Day 0

Study Arms (2)

Needle Knife Fistulotomy

ACTIVE COMPARATOR

The study doctor will gain access to the bile ducts using the cutting technique called a needle knife fistulotomy. When using this technique, the study doctor makes a cut directly into the bile duct.

Procedure: Needle knife fistulotomy

Sphincterotomy

ACTIVE COMPARATOR

The study doctor will gain access to the bile ducts using the cutting technique called a sphincterotomy. Using this method, a heated metal wire cuts the opening to the bile duct after a wire has been passed into it.

Procedure: Sphincterotomy

Interventions

Needle knife fistulotomy PROCEDURE

A needle knife fistulotomy uses a tiny knife to cut directly into the ampulla to gain access to the biliary system in patients undergoing ERCP.

Needle Knife Fistulotomy

Sphincterotomy PROCEDURE

A sphincterotomy uses a heated metal wire to cut the opening to the bile duct after a wire has been passed into it.

Sphincterotomy

Eligibility Criteria

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

You may qualify if:

• Patients, greater than, or equal to 18 years of age, with an intact sphincter undergoing ERCP by at Kingston Health Sciences Center for therapeutic purposes who can provide informed consent. This includes patients who have confirmed choledocholithiasis on imaging and those who have a high suspicion of it based on imaging and lab values. Patients with and without a high suspicion for cholangitis will be eligible for the study. Other indications include: other benign biliary duct diseases including strictures, primary sclerosing cholangitis and Mirizzi's syndrome requiring biliary decompression. Furthermore, patients with suspected diagnosis of biliary leak following cholecystectomy will also be considered for enrollment in this study.
• Ability to read and understand the English language,
• Ability to follow-up in a reliable manner.

You may not qualify if:

• Bleeding disorder (Von Willebrand disorder, platelet count \<100 000, or INR \>1.5),
• Therapeutic level anticoagulation with low molecular weight heparin (LMWH), warfarin, or a direct-acting oral anticoagulant (DOAC),
• P2Y12 inhibitors not held for 5 days prior to the procedure,
• Prior biliary sphincterotomy,
• Concurrent pancreatitis (with inability to tolerate oral intake and requiring pain management),
• Altered upper GI tract anatomy (e.g. prior gastric bypass surgery such as Roux-en-Y or Billroth 2 gastrojejunostomy),
• Inability to achieve adequate sedation,
• Evidence of malignant infiltration of the ampulla or peri-ampullary area,
• Pregnancy,
• Operator inability to access and identify intra-duodenal portion of the bile duct,
• Presumptive diagnosis of sphincter of Oddi dysfunction,
• Inability to access intraduodenal segment due to altered anatomy (eg. ampulla within deep diverticulum),
• Requirement for pancreatogram or pancreatic intervention,
• Inability to provide informed consent.

Sponsors & Collaborators

• Lawrence Charles Hookey: lead

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 5G2, Canada

Location

Related Publications (20)

• Davee T, Garcia JA, Baron TH. Precut sphincterotomy for selective biliary duct cannulation during endoscopic retrograde cholangiopancreatography. Ann Gastroenterol. 2012;25(4):291-302.

  PMID: 24714256 BACKGROUND

• Robison LS, Varadarajulu S, Wilcox CM. Safety and success of precut biliary sphincterotomy: Is it linked to experience or expertise? World J Gastroenterol. 2007 Apr 21;13(15):2183-6. doi: 10.3748/wjg.v13.i15.2183.

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• ASGE Standards of Practice Committee; Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, Eloubeidi MA, Fanelli RD, Faulx AL, Gurudu SR, Kothari S, Lightdale JR, Qumseya BJ, Shaukat A, Wang A, Wani SB, Yang J, DeWitt JM. Adverse events associated with ERCP. Gastrointest Endosc. 2017 Jan;85(1):32-47. doi: 10.1016/j.gie.2016.06.051. Epub 2016 Aug 18. No abstract available.

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• Andrade-Davila VF, Chavez-Tostado M, Davalos-Cobian C, Garcia-Correa J, Montano-Loza A, Fuentes-Orozco C, Macias-Amezcua MD, Garcia-Renteria J, Rendon-Felix J, Cortes-Lares JA, Ambriz-Gonzalez G, Cortes-Flores AO, Alvarez-Villasenor Adel S, Gonzalez-Ojeda A. Rectal indomethacin versus placebo to reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography: results of a controlled clinical trial. BMC Gastroenterol. 2015 Jul 21;15:85. doi: 10.1186/s12876-015-0314-2.

  PMID: 26195123 BACKGROUND

• Buxbaum J, Yan A, Yeh K, Lane C, Nguyen N, Laine L. Aggressive hydration with lactated Ringer's solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2014 Feb;12(2):303-7.e1. doi: 10.1016/j.cgh.2013.07.026. Epub 2013 Aug 3.

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• Shaygan-Nejad A, Masjedizadeh AR, Ghavidel A, Ghojazadeh M, Khoshbaten M. Aggressive hydration with Lactated Ringer's solution as the prophylactic intervention for postendoscopic retrograde cholangiopancreatography pancreatitis: A randomized controlled double-blind clinical trial. J Res Med Sci. 2015 Sep;20(9):838-43. doi: 10.4103/1735-1995.170597.

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• Cavallini G, Tittobello A, Frulloni L, Masci E, Mariana A, Di Francesco V. Gabexate for the prevention of pancreatic damage related to endoscopic retrograde cholangiopancreatography. Gabexate in digestive endoscopy--Italian Group. N Engl J Med. 1996 Sep 26;335(13):919-23. doi: 10.1056/NEJM199609263351302.

  PMID: 8786777 BACKGROUND

• Manes G, Ardizzone S, Lombardi G, Uomo G, Pieramico O, Porro GB. Efficacy of postprocedure administration of gabexate mesylate in the prevention of post-ERCP pancreatitis: a randomized, controlled, multicenter study. Gastrointest Endosc. 2007 Jun;65(7):982-7. doi: 10.1016/j.gie.2007.02.055.

  PMID: 17531632 BACKGROUND

• Andriulli A, Clemente R, Solmi L, Terruzzi V, Suriani R, Sigillito A, Leandro G, Leo P, De Maio G, Perri F. Gabexate or somatostatin administration before ERCP in patients at high risk for post-ERCP pancreatitis: a multicenter, placebo-controlled, randomized clinical trial. Gastrointest Endosc. 2002 Oct;56(4):488-95. doi: 10.1067/mge.2002.128130.

  PMID: 12297762 BACKGROUND

• Andriulli A, Solmi L, Loperfido S, Leo P, Festa V, Belmonte A, Spirito F, Silla M, Forte G, Terruzzi V, Marenco G, Ciliberto E, Sabatino A, Monica F, Magnolia MR, Perri F. Prophylaxis of ERCP-related pancreatitis: a randomized, controlled trial of somatostatin and gabexate mesylate. Clin Gastroenterol Hepatol. 2004 Aug;2(8):713-8. doi: 10.1016/s1542-3565(04)00295-2.

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• Yuhara H, Ogawa M, Kawaguchi Y, Igarashi M, Shimosegawa T, Mine T. Pharmacologic prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis: protease inhibitors and NSAIDs in a meta-analysis. J Gastroenterol. 2014 Mar;49(3):388-99. doi: 10.1007/s00535-013-0834-x. Epub 2013 May 30.

  PMID: 23720090 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.

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• Katsinelos P, Gkagkalis S, Chatzimavroudis G, Beltsis A, Terzoudis S, Zavos C, Gatopoulou A, Lazaraki G, Vasiliadis T, Kountouras J. Comparison of three types of precut technique to achieve common bile duct cannulation: a retrospective analysis of 274 cases. Dig Dis Sci. 2012 Dec;57(12):3286-92. doi: 10.1007/s10620-012-2271-8. Epub 2012 Jun 20.

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• Sundaralingam P, Masson P, Bourke MJ. Early Precut Sphincterotomy Does Not Increase Risk During Endoscopic Retrograde Cholangiopancreatography in Patients With Difficult Biliary Access: A Meta-analysis of Randomized Controlled Trials. Clin Gastroenterol Hepatol. 2015 Oct;13(10):1722-1729.e2. doi: 10.1016/j.cgh.2015.06.035. Epub 2015 Jul 2.

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• Ayoubi M, Sansoe G, Leone N, Castellino F. Comparison between needle-knife fistulotomy and standard cannulation in ERCP. World J Gastrointest Endosc. 2012 Sep 16;4(9):398-404. doi: 10.4253/wjge.v4.i9.398.

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• Jin YJ, Jeong S, Lee DH. Utility of needle-knife fistulotomy as an initial method of biliary cannulation to prevent post-ERCP pancreatitis in a highly selected at-risk group: a single-arm prospective feasibility study. Gastrointest Endosc. 2016 Nov;84(5):808-813. doi: 10.1016/j.gie.2016.04.011. Epub 2016 Apr 19.

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• Lopes L, Dinis-Ribeiro M, Rolanda C. Early precut fistulotomy for biliary access: time to change the paradigm of "the later, the better"? Gastrointest Endosc. 2014 Oct;80(4):634-641. doi: 10.1016/j.gie.2014.03.014. Epub 2014 May 6.

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• Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

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• Hookey L, Rai M, Bechara R. Fistulotomy versus standard cannulation as the primary technique for all patients undergoing ERCP with a native papilla: a protocol for a single center randomized controlled trial. Trials. 2022 Feb 16;23(1):153. doi: 10.1186/s13063-022-06084-4.

  PMID: 35172872 DERIVED

MeSH Terms

Conditions

Biliary Tract Diseases

Interventions

Sphincterotomy

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Myotomy; Surgical Procedures, Operative

Study Officials

• Robert Bechara, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Endoscopy

Model Details: During the procedure, the study doctor will evaluate the participant's anatomy to determine if both approaches are possible to safely perform. If both approaches are assessed as safe to perform, then the participant will be randomly assigned (like the toss of a coin) to one approach. If the study doctor is unable to gain access using the approach the patient is initially assigned to, then they will switch approaches and use the other approach.

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 23, 2020
• Study Start: September 10, 2020
• Primary Completion: March 30, 2024
• Study Completion: December 10, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)