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

NCT01954602 | Completed

• 1 other identifier: CE 13028 TNT study
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cannulation success rate

  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

  from the intervention until two days

Study Arms (2)

Touch group

ACTIVE COMPARATOR

Sphincterotome assisted guide-wire cannulation

Procedure: Sphincterotome assisted guide-wire cannulation

No touch group

EXPERIMENTAL

Guide-wire cannulation

Procedure: Guide-wire cannulation

Interventions

Guide-wire cannulation PROCEDURE

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

No touch group

Sphincterotome assisted guide-wire cannulation PROCEDURE

Sphincterotome is inserted initially a few millimeters through the papillary orifice

Touch group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Usl di Bologna: lead
• Catania Hospital Gastroenterology: collaborator
• Niguarda Hospital: collaborator

Study Sites (1)

Azienda Unità Sanitaria Locale

Bologna, Bologna, 40100, Italy

Location

Related Publications (6)

• 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. doi: 10.1016/s0016-5107(99)80010-8.

  PMID: 10536317 BACKGROUND

• 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. doi: 10.1016/s0016-5107(91)70740-2.

  PMID: 2070995 BACKGROUND

• 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.

  PMID: 1889699 BACKGROUND

• 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. doi: 10.1056/NEJM199609263351301.

  PMID: 8782497 BACKGROUND

• 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. doi: 10.1016/s0016-5107(98)70121-x.

  PMID: 9684657 BACKGROUND

• Bassi M, Luigiano C, Ghersi S, Fabbri C, Gibiino G, Balzani L, Iabichino G, Tringali A, Manta R, Mutignani M, Cennamo V. A multicenter randomized trial comparing the use of touch versus no-touch guidewire technique for deep biliary cannulation: the TNT study. Gastrointest Endosc. 2018 Jan;87(1):196-201. doi: 10.1016/j.gie.2017.05.008. Epub 2017 May 18.

  PMID: 28527615 DERIVED

MeSH Terms

Conditions

Biliary Tract Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Elio Jovine, MD

  AUSL Bologna

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: October 7, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

IT (1)