Prospective Comparison Between Ultra Early NKF Versus Standard Cannulation Alone

NCT04492137 | Unknown

• 1 other identifier: 32/2020
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the ultra early fistulotomy strategy with standard cannulation methods for accessing the bile duct during endoscopic retrograde cholangiopancreatography (ERCP)

Conditions

Pancreatitis

Keywords

ERCP; Biliary cannulation; Needle-knife fistulotomy; Standard cannulation methods

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Comparison of adverse event rate between the two strategies

  30 days from the procedure

• Technical success

  Comparison of technical success between the two strategies

  1 day (same day of the procedure)

Secondary Outcomes (2)

• Adverse event rate among sub groups

  30 days from the procedure

• Technical success among sub groups

  1 day (same day of the procedure)

Study Arms (2)

Ultra Early NKF group

EXPERIMENTAL

Patients submitted to Ultra early NKF in a consecutive fashion by an expert endoscopist

Procedure: Cannulation technique

Standard cannulation techniques group (including double-guidewire-assisted cannulation)

NO INTERVENTION

Patients submitted to standard cannulation techniques (including double-guidewire-assisted cannulation) in a consecutive fashion by an expert endoscopist

Interventions

Cannulation technique PROCEDURE

Participants in the ultra early NKF group will be submitted to 2 standard cannulation attempts (2 contacts with the papilla) before starting NKF. If any of these 2 attemps is successful, NKF won't take place. If NKF is indeed performed and cannulation is not achieved within 8 minutes, the endoscopist is free to perform techniques other than NKF. On the other hand, participants in the standard cannulation group in which cannulation is not achieved within 8 minutes can cross-over to other advanced cannulation techniques (e.g. NKF). For ethical reasons we choose to exclude flat and intradiverticular/diverticular border papillas. During ERCP all participants will be submitted to PEP prophylaxis with rectal indomethacin. A pancreatic stent will be placed whenever there is cannulation or opacification of the Wirsung duct. For the purposes of the study, a dedicated form (attached) will be created with the various variables to be analyzed

Ultra Early NKF group

Eligibility Criteria

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

You may qualify if:

• ERCP with indication for biliary access
• Naïve papilla

You may not qualify if:

• Flat papillas
• Intradiverticular / Diverticular border papillas
• Patients unable to sign or understand the informed consent
• Patients with surgically altered anatomy
• Patients with tumors of the papilla
• Previous sphincterotomy
• Spontaneous papillary fistula
• Papilla not visualized

Sponsors & Collaborators

• University of Minho: lead
• Unidade Local de Saúde do Alto Minho: collaborator

Study Sites (1)

Santa Luzia Hospital, ULS Alto Minho

Viana do Castelo, 4904-858, Portugal

RECRUITING

Related Publications (20)

• Canena J, Liberato M, Coutinho AP, Marques I, Romao C, Veiga PM, Neves BC. Predictive value of cholangioscopy after endoscopic management of early postcholecystectomy bile duct strictures with an increasing number of plastic stents: a prospective study (with videos). Gastrointest Endosc. 2014 Feb;79(2):279-88. doi: 10.1016/j.gie.2013.07.022. Epub 2013 Sep 5.

  PMID: 24012251 BACKGROUND

• Canena J, Coimbra J, Carvalho D, Rodrigues C, Silva M, Costa M, Horta D, Mateus Dias A, Seves I, Ramos G, Ricardo L, Coutinho AP, Romao C, Veiga PM. Endoscopic bilio-duodenal bypass: outcomes of primary and revision efficacy of combined metallic stents in malignant duodenal and biliary obstructions. Dig Dis Sci. 2014 Nov;59(11):2779-89. doi: 10.1007/s10620-014-3199-y. Epub 2014 May 13.

  PMID: 24821464 BACKGROUND

• Canena J, Liberato M, Meireles L, Marques I, Romao C, Coutinho AP, Neves BC, Veiga PM. A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos). Gastrointest Endosc. 2015 Jul;82(1):70-8. doi: 10.1016/j.gie.2014.11.038. Epub 2015 Mar 11.

  PMID: 25771064 BACKGROUND

• Canena J. Once upon a Time a Guideline Was Used for the Evaluation of Suspected Choledocholithiasis: A Fairy Tale or a Nightmare? GE Port J Gastroenterol. 2018 Jan;25(1):6-9. doi: 10.1159/000481688. Epub 2017 Nov 8. No abstract available.

  PMID: 29457044 BACKGROUND

• Canena J, Lopes L, Fernandes J, Alexandrino G, Lourenco L, Libanio D, Horta D, Giestas S, Reis J. Outcomes of Single-Operator Cholangioscopy-Guided Lithotripsy in Patients with Difficult Biliary and Pancreatic Stones. GE Port J Gastroenterol. 2019 Mar;26(2):105-113. doi: 10.1159/000488508. Epub 2018 May 16.

  PMID: 30976615 BACKGROUND

• Lopes L, Dinis-Ribeiro M, Rolanda C. Safety and efficacy of precut needle-knife fistulotomy. Scand J Gastroenterol. 2014 Jun;49(6):759-65. doi: 10.3109/00365521.2014.898085. Epub 2014 Mar 18.

  PMID: 24641260 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

• Testoni PA, Testoni S, Giussani A. Difficult biliary cannulation during ERCP: how to facilitate biliary access and minimize the risk of post-ERCP pancreatitis. Dig Liver Dis. 2011 Aug;43(8):596-603. doi: 10.1016/j.dld.2011.01.019. Epub 2011 Mar 4.

  PMID: 21377432 BACKGROUND

• 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.

  PMID: 24814775 BACKGROUND

• 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.

  PMID: 27102829 BACKGROUND

• 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 Apr;115(4):616-624. doi: 10.14309/ajg.0000000000000480.

  PMID: 31913191 BACKGROUND

• Mavrogiannis C, Liatsos C, Romanos A, Petoumenos C, Nakos A, Karvountzis G. Needle-knife fistulotomy versus needle-knife precut papillotomy for the treatment of common bile duct stones. Gastrointest Endosc. 1999 Sep;50(3):334-9. doi: 10.1053/ge.1999.v50.98593.

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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.

  PMID: 22714730 BACKGROUND

• Abu-Hamda EM, Baron TH, Simmons DT, Petersen BT. A retrospective comparison of outcomes using three different precut needle knife techniques for biliary cannulation. J Clin Gastroenterol. 2005 Sep;39(8):717-21. doi: 10.1097/01.mcg.0000173928.82986.56.

  PMID: 16082283 BACKGROUND

• Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N. Effect of precut sphincterotomy on biliary cannulation based on the characteristics of the major duodenal papilla. Clin Gastroenterol Hepatol. 2007 Sep;5(9):1113-8. doi: 10.1016/j.cgh.2007.05.014. Epub 2007 Aug 6.

  PMID: 17689295 BACKGROUND

• Lee TH, Bang BW, Park SH, Jeong S, Lee DH, Kim SJ. Precut fistulotomy for difficult biliary cannulation: is it a risky preference in relation to the experience of an endoscopist? Dig Dis Sci. 2011 Jun;56(6):1896-903. doi: 10.1007/s10620-010-1483-z. Epub 2010 Nov 17.

  PMID: 21082346 BACKGROUND

• Harewood GC, Baron TH. An assessment of the learning curve for precut biliary sphincterotomy. Am J Gastroenterol. 2002 Jul;97(7):1708-12. doi: 10.1111/j.1572-0241.2002.05829.x.

  PMID: 12135022 BACKGROUND

• Donnellan F, Zeb F, Courtney G, Aftab AR. Suprapapillary needleknife fistulotomy: a safe and effective method for accessing the biliary system. Surg Endosc. 2010 Aug;24(8):1937-40. doi: 10.1007/s00464-010-0881-9. Epub 2010 Feb 5.

  PMID: 20135176 BACKGROUND

• Chen DD, Keswani RN. Is Needle Knife Fistulotomy a Shortcut to Preventing Postendoscopic Retrograde Pancreatitis? Am J Gastroenterol. 2020 Apr;115(4):535-536. doi: 10.14309/ajg.0000000000000553.

  PMID: 32049681 BACKGROUND

• Khatibian M, Sotoudehmanesh R, Ali-Asgari A, Movahedi Z, Kolahdoozan S. Needle-knife fistulotomy versus standard method for cannulation of common bile duct: a randomized controlled trial. Arch Iran Med. 2008 Jan;11(1):16-20.

  PMID: 18154417 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Luís Lopes, MD, PhD, MBA

CONTACT

00351932841974; luis.m.lopes@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (MD, PhD, MBA)

Model Details: We will conduct a prospective randomized study. Participants will be randomized by computer into two groups at a 1:1 ratio 1. participants submitted to ultra early NKF 2. participants submitted to standard cannulation techniques (including double-guidewire-assisted cannulation)

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 30, 2020
• Study Start: June 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)