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Completed

NCT Number: NCT01954602

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Unità Sanitaria Locale

Bologna, 40100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guide-wire cannulation

Procedure

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

Sphincterotome assisted guide-wire cannulation

Procedure

Sphincterotome is inserted initially a few millimeters through the papillary orifice

Primary outcomes

  1. Cannulation success rate

    Time frame: No more than 5 minutes of biliary cannulation or 5 unintended pancreatic duct cannulation with the guidewire, with both techniques

Secondary outcomes

  1. Incidences of PEP

    Time frame: from the intervention until two days

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Collaborators

  • Catania Hospital Gastroenterology
  • Niguarda Hospital

Registry information

Official study title

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

Acronym: TNT

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 7, 2013
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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