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Use of Touch and no Touch Guide-wire Techniques for Deep Biliary Cannulation: the TNT Study

A Multicenter Randomized Trial Comparing the Use of Touch and no Touch Guide-wire Techniques for Deep Biliary Cannulation: the TNT Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01954602
Acronym
TNT
Enrollment
206
Registered
2013-10-07
Start date
2013-07-31
Completion date
2015-04-30
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Diseases

Keywords

Biliary cannulation, Endoscopic retrograde cholangiopancreatography, Touch guide-wire techniques, No touch guide-wire techniques

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.

Interventions

PROCEDUREGuide-wire cannulation

Direct guide-wire hovering a few millimeters through the catheter or sphincterotome

PROCEDURESphincterotome assisted guide-wire cannulation

Sphincterotome is inserted initially a few millimeters through the papillary orifice

Sponsors

Catania Hospital Gastroenterology
CollaboratorUNKNOWN
Niguarda Hospital
CollaboratorOTHER
Azienda Usl di Bologna
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Cannulation success rateNo more than 5 minutes of biliary cannulation or 5 unintended pancreatic duct cannulation with the guidewire, with both techniques

Secondary

MeasureTime frame
Incidences of PEPfrom the intervention until two days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026