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

Lawrence Hookey, Mandip Rai, Robert Bechara, Lawrence Hookey, Mandip Rai, Robert Bechara

Abstract

Background: Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable procedure for the management of pancreaticobiliary diseases. Post-ERCP pancreatitis (PEP) is the most common serious adverse event. One risk factor of PEP is difficulty achieving biliary access. The conventional ERCP technique involves the cannulation of the bile duct via the ampulla of Vater, followed by sphincter incision using electrocautery. Conventionally, if the standard method fails then, precut techniques have been utilized as an alternative means of gaining biliary access. The needle-knife fistulotomy (NKF) technique involves identifying the intra-duodenal segment of the bile duct and uses a needle knife to incise directly into the bile duct. This is done above and away from the natural office, thus minimizing thermal damage which may result in PEP. Our recent prospective study of 50 patients demonstrated the safety and feasibility of the NKF precut technique as a primary means of gaining biliary access. The next step is to conduct a randomized controlled trial to compare the efficacy and safety of initial NKF to the standard cannulation in a non-selective patient population undergoing ERCP.

Methods: A randomized control trial of 538 consecutive, non-selective patients with pancreaticobiliary disease undergoing ERCP at a tertiary care center in Kingston, Ontario, Canada, will be conducted. Patients will be randomized to one of two treatment groups, standard cannulation or NKF. The primary outcome of the study will be the incidence of PEP. Secondary outcomes will include rate of successful cannulation of the common bile duct (CBD), time to successful cannulation, total procedure time, difficulty of cannulation, and incidence of complications.

Discussion: This RCT will yield important answers regarding the efficacy and safety of initial NKF to the standard cannulation in a non-selective patient population undergoing ERCP. The results of our study could alter ERCP practices and outcomes if NKF is shown to reduce PEP risk.

Trial registration: ClinicalTrials.gov NCT04559867 . Registered on September 23, 2020.

Keywords: ERCP; Pancreatitis; Post-ERCP pancreatitis.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Flow of participants

References

    1. Davee T, Garcia J, Baron T. Precut sphincterotomy for selective biliary duct cannulation during endoscopic retrograde cholangiopancreatography. Ann Gastroenterol Q Publ Hell Soc Gastroenterol. 2012;25:291–302.
    1. Robison L, Varadarajulu S, Wilcox C. Safety and success of precut biliary sphincterotomy: is it linked to experience or expertise. World J Gastroenterol WJG. 2007;13(15):2183–2186. doi: 10.3748/wjg.v13.i15.2183.
    1. 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;85(1):32–47. doi: 10.1016/j.gie.2016.06.051.
    1. Andrade-Dávila VF, Chávez-Tostado M, Dávalos-Cobián C, García-Correa J, Montaño-Loza A, Fuentes-Orozco C, Macías-Amezcua MD, García-Rentería J, Rendón-Félix J, Cortés-Lares JA, Ambriz-González G, Cortés-Flores AO, Alvarez-Villaseñor AS, González-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;15(1):85. doi: 10.1186/s12876-015-0314-2.
    1. 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;12(2):303–7.e1. doi: 10.1016/j.cgh.2013.07.026.
    1. 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 Off J Isfahan Univ Med Sci. 2015;20(9):838–843. doi: 10.4103/1735-1995.170597.
    1. 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;335(13):919–923. doi: 10.1056/NEJM199609263351302.
    1. 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;65(7):982–987. doi: 10.1016/j.gie.2007.02.055.
    1. 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;56(4):488–495. doi: 10.1016/S0016-5107(02)70431-8.
    1. 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;2(8):713–718. doi: 10.1016/S1542-3565(04)00295-2.
    1. 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;49(3):388–399. doi: 10.1007/s00535-013-0834-x.
    1. 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. New Engla J Med. 1996;335(13):909–919. doi: 10.1056/NEJM199609263351301.
    1. Freeman ML. Adverse outcomes of ERCP. Gastrointest Endosc. 2002;56(6):S273–SS82. doi: 10.1016/S0016-5107(02)70025-4.
    1. Freeman ML, Guda NM. ERCP cannulation: a review of reported techniques. Gastrointest Endosc. 2005;61(1):112–125. doi: 10.1016/S0016-5107(04)02463-0.
    1. 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;57(12):3286–3292. doi: 10.1007/s10620-012-2271-8.
    1. Ayoubi M, Sansoè G, Leone N, Castellino F. Comparison between needle-knife fistulotomy and standard cannulation in ERCP. World J Gastrointest Endosc. 2012;4(9):398–404. doi: 10.4253/wjge.v4.i9.398.
    1. 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;13(10):1722–9.e2. doi: 10.1016/j.cgh.2015.06.035.
    1. 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;84(5):808–813. doi: 10.1016/j.gie.2016.04.011.
    1. 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;80(4):634–641. doi: 10.1016/j.gie.2014.03.014.
    1. Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991;37(3):383–393. doi: 10.1016/S0016-5107(91)70740-2.
    1. Hnaris K, Taylor C, Hookey L, Bechara R. Fistulotomy-first approach is safe and effective in endoscopic retrograde cholangiography: results of a prospective case series. J Can Assoc Gastroenterol. 2020;4(4):173–178. doi: 10.1093/jcag/gwaa025.
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346(jan08 15):e7586. doi: 10.1136/bmj.e7586.
    1. Rasheed A. Classification of acute pancreatitis—2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013.
    1. Tryliskyy Y, Bryce GJ. Post-ERCP pancreatitis: pathophysiology, early identification and risk stratification. Adv Clin Exp Med. 2018;27(1):149–154. doi: 10.17219/acem/66773.
    1. Jang SI, Kim DU, Cho JH, Jeong S, Park JS, Lee DH, Kwon CI, Koh DH, Park SW, Lee TH, Lee HS. Primary needle-knife fistulotomy versus conventional cannulation method in a high-risk cohort of post-endoscopic retrograde cholangiopancreatography pancreatitis. Am J Gastroenterol. 2020;115(4):616–624. doi: 10.14309/ajg.0000000000000480.
    1. Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft J. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020;52(2):127–149. doi: 10.1055/a-1075-4080.

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren