Influence of Vater's Ampulla Morphology on ERCP

NCT04492124 | Unknown

• 1 other identifier: 30/2020
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the influence of the papilla's morphology on the various outcomes of endoscopic retrograde cholangiopancreatography (ERCP), namely on the success of biliary cannulation, on complications, and on the need to use rescue cannulation techniques;

Conditions

Pancreatitis

Keywords

Vater's ampulla; Major Papilla; ERCP; Biliary cannulation; Precut

Outcome Measures

Primary Outcomes (1)

• Correlation between the morphology of the Vater's Ampulla and biliary cannulation difficulty

  Correlation between the morphology of the Papilla de Vater, defined by the Viana classification, and the difficulty of cannulation between experts and other endoscopists (initiates and non-expert specialists)

  1 day

Secondary Outcomes (1)

• Correlation between the morphology of the Vater's Ampulla, and complications, and need/success of advanced cannulation techniques

  up to 30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All individuals referred for CPRE in the Digestive Endoscopy Unit of the Santa Luzia Hospital, Unidade Local de Saúde do Alto Minho, will be invited to participate in the study, in the period between June 1, 2020 to June 1, 2022.

You may qualify if:

• ERCP with indication for biliary access
• Naïve papilla

You may not qualify if:

• Patients unable to 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, Unidade Local de Saúde do Alto Minho

Viana do Castelo, 4904-858, Portugal

RECRUITING

Related Publications (15)

• 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

• Lerch MM, Domschke W. Abraham Vater of the ampulla (papilla) of Vater. Gastroenterology. 2000 Feb;118(2):379. doi: 10.1016/s0016-5085(00)70243-5. No abstract available.

  PMID: 10691372 BACKGROUND

• Vater A. Dissertatio anatomica quo novum bilis dicetilicum circa orifucum ductus choledochi ut et valvulosam colli vesicæ felleæ constructionem ad disceptandum proponit. Wittenberg 1720

  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

• 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

• 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

• Watanabe M, Okuwaki K, Kida M, Imaizumi H, Yamauchi H, Kaneko T, Iwai T, Hasegawa R, Miyata E, Masutani H, Tadehara M, Adachi K, Koizumi W. Transpapillary Biliary Cannulation is Difficult in Cases with Large Oral Protrusion of the Duodenal Papilla. Dig Dis Sci. 2019 Aug;64(8):2291-2299. doi: 10.1007/s10620-019-05510-z. Epub 2019 Feb 12.

  PMID: 30746630 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Luís Lopes, MD, PhD, MBA

CONTACT

+351932841974; luis.m.lopes@me.com

João Pedro Sousa Silva R Fernandes, MD

CONTACT

+351960315790; jotillfernandes@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor University of Minho, School of Medicine

Study Record Dates

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

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)