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If Different Types of Periampullary Diverticula Affect ERCP Cannulation?

If Different Types of Periampullary Diverticula Affect ERCP Cannulation?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03556072
Enrollment
700
Registered
2018-06-14
Start date
2014-01-01
Completion date
2018-10-01
Last updated
2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation;Difficult

Keywords

ERCP, periampullary diverticula, difficulty cannulation, complication, biliary disorder

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.

Interventions

OTHERRoutine ERCP

Sponsors

Hepatopancreatobiliary Surgery Institute of Gansu Province
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difficulty cannulation1 monthThe 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

MeasureTime frameDescription
Diameter of common bile duct1 monthMaximum diameter of common bile duct observed during ERCP
X-ray exposure time1 monthThe total radiography time during ERCP
Pancreatic duct insertion times1 monthTimes of any accessories goes into the pancreatic duct, no matter how depth
Post-ERCP pancreatitis1 monthUpper abdominal pain with serum amylase elevation more than 3 times after the procedure
Diameter of diverticulum1 monthMaximum diameter of PAD observed during ERCP
Acute cholangitis1 monthIntermittent chills and fever after ERCP
Operation time1 monthFrom successful biliary intubation to end of operation
Secondary treatment rate1 monthSome patients require secondary treatment, including management of primary diseases and complications
Hospital stay1 monthLength of stay in hospital
Perforation1 monthCT scan shows retroperitoneal space fluid or gas

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026