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

Biliary Tract Diseases Clinical Trial

— TNT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954602
• Other study ID #: CE 13028 TNT study
• Status: Completed
• Phase: N/A
• First received: August 5, 2013
• Last updated: March 24, 2017
• Start date: July 2013
• Est. completion date: April 2015

Study information

• Verified date: March 2017
• Source: Azienda Usl di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Diseases

Intervention

Procedure:
• Guide-wire cannulation
Direct guide-wire hovering a few millimeters through the catheter or sphincterotome
• Sphincterotome assisted guide-wire cannulation
Sphincterotome is inserted initially a few millimeters through the papillary orifice

Locations

Country	Name	City	State
Italy	Azienda Unità Sanitaria Locale	Bologna

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Usl di Bologna	Catania Hospital Gastroenterology, Niguarda Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannulation success rate		No more than 5 minutes of biliary cannulation or 5 unintended pancreatic duct cannulation with the guidewire, with both techniques
Secondary	Incidences of PEP		from the intervention until two days