Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precut Sphincterotomy Arm | Experimental | Participants undergo biliary cannulation using precut sphincterotomy as the initial rescue cannulation technique during ERCP. |
|
| Double Guidewire Technique Arm | Active Comparator | Participants undergo biliary cannulation using the double guidewire technique, with placement of a guidewire in the pancreatic duct followed by attempted biliary cannulation during ERCP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precut Sphincterotomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safe Success | SUCCESS: Deep cannulation of the Common Bile Duct (CBD) achieved using the randomized technique within 15 minutes.
Post ERCP adverse events include Post ERCP Pancreatitis, Hemorrhage, cholangitis and perforation. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Severity of Post-ERCP Pancreatitis |
Not provided
Inclusion Criteria:
- Age > 18 years.
Exclusion Criteria:
Ampullary mass or tumor preventing standard cannulation view.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DR SHUJAATH ASIF, MD,DM | Contact | 9600037286 | Asif.shujaath@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| DR SHUJAATH ASIF, MD,DM | Asian Institute Of Gastroenterology Private Limited | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Double Guidewire Technique | Procedure | 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. |
|
Severity of post-ERCP pancreatitis classified as mild, moderate, or severe according to the revised Atlanta classification. |
| 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. | 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. | During the ERCP procedure |
| Total Procedure Time | Total ERCP procedure duration, measured from duodenoscope insertion to scope withdrawal. | 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. | 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. | At 24 hours after ERCP |
| Hospital Length of Stay | Duration of hospital stay measured in days from ERCP to hospital discharge | Up to 30 days after ERCP |
| 30-Day All-Cause Readmission | Rate of hospital readmission for any cause after ERCP. | Up to 30 days after ERCP |
| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002769 | Cholelithiasis |
Not provided
Not provided