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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Precut Sphincterotomy
Procedure/SurgeryPrecut 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/SurgeryThe 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Severity of Post-ERCP Pancreatitis
Severity of post-ERCP pancreatitis classified as mild, moderate, or severe according to the revised Atlanta classification.
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.
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.
Locations
Sponsors and contacts
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