If Different Types of Periampullary Diverticula Affect ERCP Cannulation?
- Conditions
- Intubation;Difficult
- Interventions
- Other: Routine ERCP
- Registration Number
- NCT03556072
- Lead Sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Brief Summary
To study the influence of different types of periampullary diverticulum(PAD) on ERCP difficult cannulation and postoperative complications.
- Detailed Description
Periampullary diverticula (PAD) are extraluminal out-pouching of the duodenum mucosa often occurring within a radius of 2-3 cm from the ampulla of Vater or hepatopancreatic ampulla. More PAD cases have been identified over recent years, and it's generally believed that up to 27% of elderly cases may have PAD. Several classifications of PAD have been proposed, and the most commonly used distinguishes intraluminal and extraluminal diverticula. Recent studies suggest that PAD is a risk factor for the development of bile duct diseases, and it may cause endoscopic retrograde cholangiopancreatography (ERCP) procedures to fail, but some other studies have come to the opposite conclusion.
During ERCP procedures, the investigators found that different types of PAD seem to have some differences in the size of the diverticulum, difficulty in intubation, and complications. The investigators plan to this retrospectively study collecting 4 years of cases to evaluate the clinical features of different types of PAD in terms of difficult cannulation and complications.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
- 18-90 years old ERCP patients
- With native papilla
- Unwillingness or inability to consent for the study
- Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count (<50×10^9 / L) or using anti-coagulation drugs
- Previous ERCP
- Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, severe liver disease(such as decompensated liver cirrhosis, liver failure and so on), septic shock
- Biliary-duodenal fistula confirmed during ERCP
- Pregnant women or breastfeeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Juxtapapillary diverticulum (JPD) group Routine ERCP Routine ERCP, recording the endoscopic procedures and observing the intra- and post-operative parameters Intradiverticular papilla (IDP) group Routine ERCP Routine ERCP, recording the endoscopic procedures and observing the intra- and post-operative parameters
- Primary Outcome Measures
Name Time Method Difficulty cannulation 1 month The inability to achieve selective biliary cannulation by the standard ERCP technique within 10 minutes or 5 attempts or failure of access to the major papilla.
- Secondary Outcome Measures
Name Time Method Perforation 1 month CT scan shows retroperitoneal space fluid or gas
Secondary treatment rate 1 month Some patients require secondary treatment, including management of primary diseases and complications
Hospital stay 1 month Length of stay in hospital
Diameter of common bile duct 1 month Maximum diameter of common bile duct observed during ERCP
X-ray exposure time 1 month The total radiography time during ERCP
Acute cholangitis 1 month Intermittent chills and fever after ERCP
Diameter of diverticulum 1 month Maximum diameter of PAD observed during ERCP
Operation time 1 month From successful biliary intubation to end of operation
Pancreatic duct insertion times 1 month Times of any accessories goes into the pancreatic duct, no matter how depth
Post-ERCP pancreatitis 1 month Upper abdominal pain with serum amylase elevation more than 3 times after the procedure
Trial Locations
- Locations (1)
Hepatopancreatobiliary Surgery Institute of Gansu Province
🇨🇳Lanzhou, Gansu, China