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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Biliary Tract Diseases

Intervention / Treatment
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* Procedure: Guide-wire cannulation
* Procedure: Sphincterotome assisted guide-wire cannulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Touch group<br>Sphincterotome assisted guide-wire cannulation | Procedure: Sphincterotome assisted guide-wire cannulation<br>* Sphincterotome is inserted initially a few millimeters through the papillary orifice<br>|
| Experimental: No touch group<br>Guide-wire cannulation | Procedure: Guide-wire cannulation<br>* Direct guide-wire hovering a few millimeters through the catheter or sphincterotome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cannulation success rate |  | No more than 5 minutes of biliary cannulation or 5 unintended pancreatic duct cannulation with the guidewire, with both techniques | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of PEP |  | from the intervention until two days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary cannulation, Endoscopic retrograde cholangiopancreatography, Touch guide-wire techniques, No touch guide-wire techniques