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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
840
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.
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.
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
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
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
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
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
Total Procedure Time
Total ERCP procedure duration, measured from duodenoscope insertion to scope withdrawal.
Time frame: During the ERCP procedure
Need for Rescue Cannulation Technique
Proportion of patients requiring crossover to an alternative rescue cannulation technique after failure of the initially assigned technique.
Time frame: During the ERCP procedure
Hyperamylasemia Without Clinical Pancreatitis
Incidence of asymptomatic hyperamylasemia, defined as serum amylase or lipase ≥3 times the upper limit of normal without clinical features of pancreatitis.
Time frame: At 24 hours after ERCP
Hospital Length of Stay
Duration of hospital stay measured in days from ERCP to hospital discharge
Time frame: Up to 30 days after ERCP
30-Day All-Cause Readmission
Rate of hospital readmission for any cause after ERCP.
Time frame: Up to 30 days after ERCP
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.