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Completed

NCT Number: NCT03556072

If Different Types of Periampullary Diverticula Affect ERCP Cannulation?

To study the influence of different types of periampullary diverticulum(PAD) on ERCP difficult cannulation and postoperative complications.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine ERCP

Other

Primary outcomes

  1. Difficulty cannulation

    Time frame: 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 outcomes

  1. Diameter of diverticulum

    Time frame: 1 month

    Maximum diameter of PAD observed during ERCP

  2. Diameter of common bile duct

    Time frame: 1 month

    Maximum diameter of common bile duct observed during ERCP

  3. X-ray exposure time

    Time frame: 1 month

    The total radiography time during ERCP

  4. Pancreatic duct insertion times

    Time frame: 1 month

    Times of any accessories goes into the pancreatic duct, no matter how depth

  5. Post-ERCP pancreatitis

    Time frame: 1 month

    Upper abdominal pain with serum amylase elevation more than 3 times after the procedure

  6. Perforation

    Time frame: 1 month

    CT scan shows retroperitoneal space fluid or gas

  7. Acute cholangitis

    Time frame: 1 month

    Intermittent chills and fever after ERCP

  8. Operation time

    Time frame: 1 month

    From successful biliary intubation to end of operation

  9. Secondary treatment rate

    Time frame: 1 month

    Some patients require secondary treatment, including management of primary diseases and complications

  10. Hospital stay

    Time frame: 1 month

    Length of stay in hospital

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2018
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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