Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAsian Institute of Gastroenterology, India

About this trial

Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. The procedure has revolutionized the management of these conditions, often obviating the need for surgery.Precut papillotomy and Double Guidewire Technique (DGT) are both salvage techniques used in ERCP when standard biliary cannulation fails.

Precut (Needle-Knife Precut): An endoscopic incision made into the papilla to gain access to the bile duct when conventional methods fail.

Intentional Double Guidewire Technique (DGT): A technique where a guidewire is intentionally placed into the pancreatic duct to act as a "guide" or anchor, straightening the biliary axis and allowing a second guidewire to be inserted into the bile duct.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Valid indication for ERCP (benign or malignant obstruction).

Native papilla (no prior sphincterotomy).

> 5 minutes of cannulation attempts.

> 5 contacts with the papilla.

Disqualifiers

Ampullary mass or tumor preventing standard cannulation view.

Surgically altered anatomy (e.g., Billroth II, Roux-en-Y).

Uncorrectable coagulopathy (INR > 1.5 or Platelets < 50,000).

Acute pancreatitis present prior to ERCP.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Precut Sphincterotomy

    Procedure/Surgery

    Precut sphincterotomy is an endoscopic rescue cannulation technique in which a needle-knife or similar cutting instrument is used to incise the papillary or periampullary tissue to facilitate access to the bile duct during ERCP.

  • Double Guidewire Technique

    Procedure/Surgery

    The double guidewire technique is an endoscopic rescue cannulation method in which a guidewire is placed into the pancreatic duct to stabilize the papilla, followed by attempted biliary cannulation alongside the pancreatic duct guidewire during ERCP.

Treatment groups

840 Participants
are divided into 2 treatment groups
Group A: Precut Sphincterotomy ArmExperimental treatment 1 intervention
Group B: Double Guidewire Technique ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safe Success

SUCCESS: Deep cannulation of the Common Bile Duct (CBD) achieved using the randomized technique within 15 minutes. * AND ABSENCE OF Post ERCP adverse events. Post ERCP adverse events include Post ERCP Pancreatitis, Hemorrhage, cholangitis and perforation.

Time frame
30 Days

Secondary outcomes

1

Incidence of Post-ERCP Pancreatitis

Incidence of post-ERCP pancreatitis, defined as new or worsened abdominal pain with serum amylase or lipase ≥3 times the upper limit of normal at ≥24 hours after ERCP, requiring hospitalization or prolongation of planned admission.

Time frame
30 days
2

Severity of Post-ERCP Pancreatitis

Severity of post-ERCP pancreatitis classified as mild, moderate, or severe according to the revised Atlanta classification.

Time frame
30 days
3

Overall ERCP-Related Adverse Events

Incidence of ERCP-related adverse events, including bleeding, perforation, cholangitis, and post-ERCP pancreatitis, graded according to the ASGE lexicon.

Time frame
30 days
4

Cannulation Time

Time required to achieve deep biliary cannulation, measured from insertion of the duodenoscope into the second part of the duodenum to successful deep bile duct cannulation.

Time frame
During the ERCP procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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