Health TrialsbyHealthPanel

Efficacy of Fistulotomy for Biliary Cannulation

ConditionsCholangiocarcinomaCholedocholithiasis; CholangitisPancreatic CancerPancreatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorCoordinación de Investigación en Salud, Mexico

About this trial

Access to the main bile duct is the first step in order to perform a therapeutic maneuver for biliary diseases. Early precut has been shown to ameliorate cannulation success rate, specially in difficult cannulation cases, when compared to guidewire cannulation (which is considered, for most, the standard technique). We aim to perform a randomized clinical trial comparing fistulotomy (F) precut vs guidewire cannulation (CC), as a primary cannulation technique, and compare outcomes between high experienced endoscopists (\> 200 ERCPs\[Endoscopic Retrograde cholangiopancreatography\]) and low experienced endoscopists (\< 200 ERCPs).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients undergoing ERCP with suspected or confirmed of choledocholithiasis, malignant and benign biliary stenosis.

Disqualifiers

patients with previous ERCP, altered gastro-duodenal anatomy by previous surgery, suspicion or diagnosis of ampullary neoplasm, duodenal cancer, periampullary diverticula types 1 and 2, pregnant women, coagulopathy with INR greater than 1.5.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fistulotomy - High experienced.

    Procedure/Surgery

    We will perform a duodenoscopy, once located next to the papilla, we will perform precut fistulotomy on the papillary infundibulum with a needle knife with EBRE, EndoCut I, Effect 2, until biliary fluid exit is seen or the biliary duct is noted, then we will access to the biliary tree to complete de procedure.

  • Fistulotomy - Low experienced.

    Procedure/Surgery

    We will perform a duodenoscopy, once located next to the papilla, we will perform precut fistulotomy on the papillary infundibulum with a needle knife with EBRE, EndoCut I, Effect 2, until biliary fluid exit is seen or the biliary duct is noted, then we will access to the biliary tree to complete de procedure.

  • Conventional (guidewire) cannulation- High experienced

    Procedure/Surgery

    We will perform a duodenoscopy, once located next to the papilla, we will perform cannulation with sphincterotome and hydrophilic tipped guidewire aided by fluoroscopy, once the guidewire reaches de common bile duct (seen on fluoroscopy) we will continue with the procedure according to the patient's indication.

  • Conventional (guidewire) cannulation - Low experienced

    Procedure/Surgery

    We will perform a duodenoscopy, once located next to the papilla, we will perform cannulation with sphincterotome and hydrophilic tipped guidewire aided by fluoroscopy, once the guidewire reaches de common bile duct (seen on fluoroscopy) we will continue with the procedure according to the patient's indication.

Treatment groups

320 Participants
are divided into 4 treatment groups
Group A: Fistulotomy - High experiencedActive comparator 1 intervention
Group B: Fistulotomy - Low experiencedActive comparator 1 intervention
Group C: Conventional (guidewire) cannulation- High experienceActive comparator 1 intervention
Group D: Conventional (guidewire) cannulation - Low experienced.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cannulation success rate within 5 minutes

Successful access to the main biliary duct and subsequently to the biliary tree

Time frame
8 months

Secondary outcomes

1

Adverse event rate

Post-ERCP pancreatitis, perforation and bleeding rates

Time frame
8 months
2

Technical success

Therapeutic success according to the patient indication

Time frame
8 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Coordinación de Investigación en Salud, Mexico

Lead sponsor

Source ClinicalTrials.gov
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