Early Versus Delayed Double-guidewire Technique in Difficult Biliary Cannulation. (DFG)

Catheterization Clinical Trial

— DFG  

Official title:

Study Assessing the Interest of the Double-guidewire Technique for Catheterization of the Common Bile Duct.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582540
• Other study ID #: ID RCB: 2016-A01016-45
• Status: Completed
• Phase: N/A
• Start date: November 2, 2016
• Est. completion date: August 30, 2019

Study information

• Verified date: June 2018
• Source: Société Française d'Endoscopie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomized comparative multicentric study. Briefly, we will analyze the technical success, performance and clinical outcomes of early versus delayed double-guidewire technique (DGT) in difficult biliary cannulation.

Description:

This is a prospective study performed in 20 tertiary medical centers in France. We aim to recruit 150 patients from 2016 to 2020. Patients with a native papilla scheduled for ERCP (endoscopic retrograde cholangiopancreatography) are screened for the study. Patients with a difficult biliary cannulation are included in the study if the guidewire is inserted in the pancreatic duct. At that point, patients are randomized in two arms: early versus delayed DGT. The early arm attempts biliary cannulation using the double-guidewire technique immediately and the delayed arm uses the double-guidewire technique only if 10 more minutes of standard cannulation technique does not allow biliary cannulation. The primary outcome is the biliary cannulation rate success. Secondary outcomes are complications rate and performance of the technique in both arms. Follow-up is 30 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18 years old and more

• Native papilla

• Clinical indications of ERCP

• Difficult biliary cannulation defined by unintentional guidewire insertion into the pancreatic duct before biliary cannulation is successful

• Informed consent completed by the patient

Exclusion Criteria:

• Contraindication to upper gastrointestinal endoscopy

• ERCP with direct biliary cannulation success

• ERCP with inability to cannulate the bile duct nor the pancreatic duct

• Coagulation or hemostasis disorder (TP < 60%, TCA> 40 sec. et plaquettes < 60000/mm3).

• Patient under active antiaggregant or anticoagulant medication other than aspirin

• Endoscopic treatment of chronic pancreatitis

• Pregnancy or breastfeeding

• ERCP performed by another operator than an investigator

• Patient's voluntary withdrawal

• Withdrawal decision by the investigator or sponsor

Related Conditions & MeSH terms

• Biliary Cannulation
• Catheterization
• Cholangiopancreatography
• Difficult Biliary Cannulation
• Double-guidewire Technique
• Endoscopic Retrograde Cholangiography

Intervention

Procedure:
• Double-guidewire cannulation technique
With the DGT, a guidewire is first inserted deep into the PD. The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.

Locations

Country	Name	City	State
France	Clinique de Bercy	Charenton-le-Pont
France	Hôpital Dupuytren	Limoges
France	Hopital Saint Joseph	Marseille
France	Groupe Hospitalier Diaconesses - La Croix Saint-Simon	Paris
France	Hôpital Haut Lévêque	Pessac
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	Centre Hospitalier de Bigorre	Tarbes
France	Centre Hospitalier de Vichy	Vichy

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Country where clinical trial is conducted

France, 

References & Publications (23)

Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP — View Citation

Angsuwatcharakon P, Rerknimitr R, Ridtitid W, Ponauthai Y, Kullavanijaya P. Success rate and cannulation time between precut sphincterotomy and double-guidewire technique in truly difficult biliary cannulation. J Gastroenterol Hepatol. 2012 Feb;27(2):356- — View Citation

Artifon EL, Sakai P, Cunha JE, Halwan B, Ishioka S, Kumar A. Guidewire cannulation reduces risk of post-ERCP pancreatitis and facilitates bile duct cannulation. Am J Gastroenterol. 2007 Oct;102(10):2147-53. Epub 2007 Jun 20. — View Citation

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Cennamo V, Fuccio L, Repici A, Fabbri C, Grilli D, Conio M, D'Imperio N, Bazzoli F. Timing of precut procedure does not influence success rate and complications of ERCP procedure: a prospective randomized comparative study. Gastrointest Endosc. 2009 Mar;6 — View Citation

Cennamo V, Fuccio L, Zagari RM, Eusebi LH, Ceroni L, Laterza L, Fabbri C, Bazzoli F. Can early precut implementation reduce endoscopic retrograde cholangiopancreatography-related complication risk? Meta-analysis of randomized controlled trials. Endoscopy. — View Citation

Coté GA, Mullady DK, Jonnalagadda SS, Keswani RN, Wani SB, Hovis CE, Ammar T, Al-Lehibi A, Edmundowicz SA, Komanduri S, Azar RR. Use of a pancreatic duct stent or guidewire facilitates bile duct access with low rates of precut sphincterotomy: a randomized — View Citation

Dumonceau JM, Devière J, Cremer M. A new method of achieving deep cannulation of the common bile duct during endoscopic retrograde cholangiopancreatography. Endoscopy. 1998 Sep;30(7):S80. — View Citation

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Freeman ML, Guda NM. ERCP cannulation: a review of reported techniques. Gastrointest Endosc. 2005 Jan;61(1):112-25. Review. — View Citation

Goff JS. Long-term experience with the transpancreatic sphincter pre-cut approach to biliary sphincterotomy. Gastrointest Endosc. 1999 Nov;50(5):642-5. — View Citation

Gotoh Y, Tamada K, Tomiyama T, Wada S, Ohashi A, Satoh Y, Higashizawa T, Miyata T, Ido K, Sugano K. A new method for deep cannulation of the bile duct by straightening the pancreatic duct. Gastrointest Endosc. 2001 Jun;53(7):820-2. — View Citation

Herreros de Tejada A, Calleja JL, Díaz G, Pertejo V, Espinel J, Cacho G, Jiménez J, Millán I, García F, Abreu L; UDOGUIA-04 Group. Double-guidewire technique for difficult bile duct cannulation: a multicenter randomized, controlled trial. Gastrointest End — View Citation

Hisa T, Matsumoto R, Takamatsu M, Furutake M. Impact of changing our cannulation method on the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis after pancreatic guidewire placement. World J Gastroenterol. 2011 Dec 28;17(48):52 — View Citation

Lee TH, Hwang SO, Choi HJ, Jung Y, Cha SW, Chung IK, Moon JH, Cho YD, Park SH, Kim SJ. Sequential algorithm analysis to facilitate selective biliary access for difficult biliary cannulation in ERCP: a prospective clinical study. BMC Gastroenterol. 2014 Fe — View Citation

Osnes M, Kahrs T. Endoscopic choledochoduodenostomy for choledocholithiasis through choledochoduodenal fistula. Endoscopy. 1977 Aug;9(3):162-5. — View Citation

Parlak E, Cicek B, Disibeyaz S, Kuran S, Sahin B. Early decision for precut sphincterotomy: is it a risky preference? Dig Dis Sci. 2007 Mar;52(3):845-51. — View Citation

Siegel JH. Precut papillotomy: a method to improve success of ERCP and papillotomy. Endoscopy. 1980 May;12(3):130-3. — View Citation

Slivka A. A new technique to assist in bile duct cannulation. Gastrointest Endosc. 1996 Nov;44(5):636. — View Citation

Tang SJ, Haber GB, Kortan P, Zanati S, Cirocco M, Ennis M, Elfant A, Scheider D, Ter H, Dorais J. Precut papillotomy versus persistence in difficult biliary cannulation: a prospective randomized trial. Endoscopy. 2005 Jan;37(1):58-65. — View Citation

Vandervoort J, Soetikno RM, Tham TC, Wong RC, Ferrari AP Jr, Montes H, Roston AD, Slivka A, Lichtenstein DR, Ruymann FW, Van Dam J, Hughes M, Carr-Locke DL. Risk factors for complications after performance of ERCP. Gastrointest Endosc. 2002 Nov;56(5):652- — View Citation

Xinopoulos D, Bassioukas SP, Kypreos D, Korkolis D, Scorilas A, Mavridis K, Dimitroulopoulos D, Paraskevas E. Pancreatic duct guidewire placement for biliary cannulation in a single-session therapeutic ERCP. World J Gastroenterol. 2011 Apr 21;17(15):1989- — View Citation

Yoo YW, Cha SW, Lee WC, Kim SH, Kim A, Cho YD. Double guidewire technique vs transpancreatic precut sphincterotomy in difficult biliary cannulation. World J Gastroenterol. 2013 Jan 7;19(1):108-14. doi: 10.3748/wjg.v19.i1.108. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biliary cannulation success rate	The percentage of biliary cannulation success in both arms.	During the ERCP procedure
Secondary	Immediate morbidity	Any complications (procedure related, clinical or anesthesiological) occurring during the procedure or during the immediate post-intervention period.	From the start, until 30 minutes after completion of ERCP
Secondary	Delayed morbidity	Morbidities occurring more than 30 minutes and up to 1 month after ERCP completion. Special attention will be taken for bowel perforation, gastrointestinal bleeding and acute pancreatitis	30 minutes after ERCP completion and up to 30 days
Secondary	procedural time	The time taken in minutes between patient randomization (at the first guidewire insertion into the pancreatic duct) and successful biliary cannulation.	time from the first guidewire insertion into the pancreatic duct up to the end of cannulation.