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

Azienda Usl di Bologna

Status

Completed

Conditions

Biliary Tract Diseases

Treatments

Procedure: Sphincterotome assisted guide-wire cannulation

Procedure: Guide-wire cannulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01954602

CE 13028 TNT study

Details and patient eligibility

About

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.

Full 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.

Enrollment

206 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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