If Different Types of Periampullary Diverticula Affect ERCP Cannulation?

Intubation;Difficult Clinical Trial

Official title:

If Different Types of Periampullary Diverticula Affect ERCP Cannulation?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556072
• Other study ID #: PAD affects ERCP cannulation
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: October 1, 2018

Study information

• Verified date: October 2018
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 ?, 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

Related Conditions & MeSH terms

• Diverticulum
• Intubation;Difficult

Intervention

Other:
• Routine ERCP

Locations

Country	Name	City	State
China	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (5)

Cappell MS, Mogrovejo E, Manickam P, Batke M. Endoclips to facilitate cannulation and sphincterotomy during ERCP in a patient with an ampulla within a large duodenal diverticulum: case report and literature review. Dig Dis Sci. 2015 Jan;60(1):168-73. doi: — View Citation

Katsinelos P, Chatzimavroudis G, Tziomalos K, Zavos C, Beltsis A, Lazaraki G, Terzoudis S, Kountouras J. Impact of periampullary diverticula on the outcome and fluoroscopy time in endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis — View Citation

Kim KY, Han J, Kim HG, Kim BS, Jung JT, Kwon JG, Kim EY, Lee CH. Late Complications and Stone Recurrence Rates after Bile Duct Stone Removal by Endoscopic Sphincterotomy and Large Balloon Dilation are Similar to Those after Endoscopic Sphincterotomy Alone — View Citation

Lobo DN, Balfour TW, Iftikhar SY. Periampullary diverticula: consequences of failed ERCP. Ann R Coll Surg Engl. 1998 Sep;80(5):326-31. — View Citation

Tyagi P, Sharma P, Sharma BC, Puri AS. Periampullary diverticula and technical success of endoscopic retrograde cholangiopancreatography. Surg Endosc. 2009 Jun;23(6):1342-5. doi: 10.1007/s00464-008-0167-7. Epub 2008 Sep 26. — View Citation

Outcome

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