Clinical trial NCT01954602: Use of Touch and no Touch Guide-wire Techniques for Deep Biliary Cannulation: the TNT Study
Official title: A Multicenter Randomized Trial Comparing the Use of Touch and no Touch Guide-wire Techniques for Deep Biliary Cannulation: the TNT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Tract Diseases
Keywords: Biliary cannulation
Endoscopic retrograde cholangiopancreatography
Touch guide-wire techniques
No touch guide-wire techniques
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
Collaborators: name: Catania Hospital Gastroenterology
name: Niguarda Hospital
First posted: 2013-10-07
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The specific goal of this study is to compare the deep biliary cannulation rate and complication rates associated with use of touch and no touch guide-wire biliary cannulation techniques.

Detailed description: The most common technique used to achieve primary deep biliary cannulation is the standard contrast-assisted method, in which a catheter or sphincterotome is introduced into the papilla in the direction of the bile duct and a contrast medium injected to confirm that the duct has been cannulated.

The biliary guidewire cannulation technique consists of the introduction of a guide-wire into the bile duct instead of contrast injection as the first maneuver.

The benefit of this technique, compared with classic contrast cannulation, has been demonstrated in several studies which show similar results and have been analyzed in a recent meta-analysis, including 5 studies and 1762 patients, and demonstrating that the use of the guide-wire technique significantly improved the primary cannulation rate from 74.9% to 85.3%. More importantly, significantly reduced the incidence of PEP from 8.6% to 1.6%.

There are several variations of this technique; the tip of the sphincterotome is inserted initially a few millimeters through the papillary orifice and then introduce the guide-wire to the target ("touch technique"). Another variation is direct cannulation with the guide-wire hovering a few millimeters through the catheter or sphincterotome ("no touch technique").

To date, there are no randomized controlled trials comparing the two above described way to access to biliary duct regarding efficacy and rate of complications.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Clinical symptoms, laboratory findings and radiological evidences of biliary disease
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

* Age \<18 yars
* Patients with previous sphincterotomy
* Patients with previous papillary endoscopic balloon dilation
* Presence of a previously placed plastic or metal biliary stent
* Presence of any esophageal or gastro/duodenal stent
* Pancreatic or ampullary cancer, proven by imaging and/or cytology and/or histology, are excluded as PEP is very uncommon in these subgroups and tumour-related anatomical variation may alter cannulation technique (consider substratify results for this subgroup, but exclude if duodenal stenosis precludes an attempt on the papilla)
* Patients with surgically altered anatomy (Bilroth II gastrectomy and Roux en Y anastomosis) are excluded as cannulation technique is fundamentally different from that in normal anatomy
* Presence of a diverticular papilla
* Presence of a duodenal stenosis
* Presence of a pancreas divisum
* Patients with contraindication to endoscopic procedures
* Hemodinynamic instability, any acute illness or exacerbation of chronic illness, acute infections.
* Platelet count less than 50,000/mm3 and INR no greater than 1.5 times upper limit of normal
* Inability or refusal to give informed consent.
* Refusal to provide consent

Primary outcomes:
measure: Cannulation success rate
timeFrame: No more than 5 minutes of biliary cannulation or 5 unintended pancreatic duct cannulation with the guidewire, with both techniques
Secondary outcomes:
measure: Incidences of PEP
timeFrame: from the intervention until two days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Unità Sanitaria Locale
Study officials:
affiliation: AUSL Bologna
name: Elio Jovine, MD
role: STUDY_CHAIR
References:
citation: Rabenstein T, Schneider HT, Nicklas M, Ruppert T, Katalinic A, Hahn EG, Ell C. Impact of skill and experience of the endoscopist on the outcome of endoscopic sphincterotomy techniques. Gastrointest Endosc. 1999 Nov;50(5):628-36. doi: 10.1016/s0016-5107(99)80010-8.
citation: Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
citation: Sherman S, Ruffolo TA, Hawes RH, Lehman GA. Complications of endoscopic sphincterotomy. A prospective series with emphasis on the increased risk associated with sphincter of Oddi dysfunction and nondilated bile ducts. Gastroenterology. 1991 Oct;101(4):1068-75.
citation: 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.
citation: Loperfido S, Angelini G, Benedetti G, Chilovi F, Costan F, De Berardinis F, De Bernardin M, Ederle A, Fina P, Fratton A. Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study. Gastrointest Endosc. 1998 Jul;48(1):1-10. doi: 10.1016/s0016-5107(98)70121-x.
citation: Bassi M, Luigiano C, Ghersi S, Fabbri C, Gibiino G, Balzani L, Iabichino G, Tringali A, Manta R, Mutignani M, Cennamo V. A multicenter randomized trial comparing the use of touch versus no-touch guidewire technique for deep biliary cannulation: the TNT study. Gastrointest Endosc. 2018 Jan;87(1):196-201. doi: 10.1016/j.gie.2017.05.008. Epub 2017 May 18.