If Different Types of Periampullary Diverticula Affect ERCP Cannulation?

Study Overview
=================
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.

Official Title
-----------------
If Different Types of Periampullary Diverticula Affect ERCP Cannulation?

Conditions
-----------------
Intubation;Difficult

Intervention / Treatment
-----------------
* Other: Routine ERCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-90 years old ERCP patients With native papilla Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intradiverticular papilla (IDP) group<br>Routine ERCP, recording the endoscopic procedures and observing the intra- and post-operative parameters | Other: Routine ERCP<br> <br> |
| Juxtapapillary diverticulum (JPD) group<br>Routine ERCP, recording the endoscopic procedures and observing the intra- and post-operative parameters | Other: Routine ERCP<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulty cannulation | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter of diverticulum | Maximum diameter of PAD observed during ERCP | 1 month | 
| Diameter of common bile duct | Maximum diameter of common bile duct observed during ERCP | 1 month | 
| X-ray exposure time | The total radiography time during ERCP | 1 month | 
| Pancreatic duct insertion times | Times of any accessories goes into the pancreatic duct, no matter how depth | 1 month | 
| Post-ERCP pancreatitis | Upper abdominal pain with serum amylase elevation more than 3 times after the procedure | 1 month | 
| Perforation | CT scan shows retroperitoneal space fluid or gas | 1 month | 
| Acute cholangitis | Intermittent chills and fever after ERCP | 1 month | 
| Operation time | From successful biliary intubation to end of operation | 1 month | 
| Secondary treatment rate | Some patients require secondary treatment, including management of primary diseases and complications | 1 month | 
| Hospital stay | Length of stay in hospital | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, periampullary diverticula, difficulty cannulation, complication, biliary disorder