Biliary Drainage, Biliary Stricture, Biliary Strictures Caused by Malignant Neoplasms, Choledocholithiasis, ERCP
Conditions
Keywords
Selective CBD cannulation, Post ERCP Pancreatitis, Precut Sphincterotomy, Double Guidewire Technique
Brief summary
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.
Interventions
PROCEDUREPrecut Sphincterotomy
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.
PROCEDUREDouble Guidewire Technique
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.
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\- Age \> 18 years. * Valid indication for ERCP (benign or malignant obstruction). * Native papilla (no prior sphincterotomy). * Difficult Biliary Cannulation (DBC) defined by ESGE 5-5-2 criteria: * \> 5 minutes of cannulation attempts. * \> 5 contacts with the papilla. * \> 1 inadvertent pancreatic duct cannulation.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safe Success | 30 Days | 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
| Measure | Time frame | Description |
|---|---|---|
| Need for Rescue Cannulation Technique | During the ERCP procedure | Proportion of patients requiring crossover to an alternative rescue cannulation technique after failure of the initially assigned technique. |
| Incidence of Post-ERCP Pancreatitis | 30 days | 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 | 30 days | Severity of post-ERCP pancreatitis classified as mild, moderate, or severe according to the revised Atlanta classification. |
| Overall ERCP-Related Adverse Events | 30 days | Incidence of ERCP-related adverse events, including bleeding, perforation, cholangitis, and post-ERCP pancreatitis, graded according to the ASGE lexicon. |
| Total Procedure Time | During the ERCP procedure | Total ERCP procedure duration, measured from duodenoscope insertion to scope withdrawal. |
| Hyperamylasemia Without Clinical Pancreatitis | At 24 hours after ERCP | Incidence of asymptomatic hyperamylasemia, defined as serum amylase or lipase ≥3 times the upper limit of normal without clinical features of pancreatitis. |
| Hospital Length of Stay | Up to 30 days after ERCP | Duration of hospital stay measured in days from ERCP to hospital discharge |
| 30-Day All-Cause Readmission | Up to 30 days after ERCP | Rate of hospital readmission for any cause after ERCP. |
| Cannulation Time | During the ERCP procedure | 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. |
Contacts
Primary ContactDR SHUJAATH ASIF, MD,DM
Outcome results
None listed