Clinical trial NCT03556072: If Different Types of Periampullary Diverticula Affect ERCP Cannulation?
Official title: If Different Types of Periampullary Diverticula Affect ERCP Cannulation?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation;Difficult
Keywords: ERCP
periampullary diverticula
difficulty cannulation
complication
biliary disorder
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18-90 years old patients with ERCP indications

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.

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

Primary outcomes:
measure: Difficulty cannulation
timeFrame: 1 month
Secondary outcomes:
measure: Diameter of diverticulum
timeFrame: 1 month
measure: Diameter of common bile duct
timeFrame: 1 month
measure: X-ray exposure time
timeFrame: 1 month
measure: Pancreatic duct insertion times
timeFrame: 1 month
measure: Post-ERCP pancreatitis
timeFrame: 1 month
measure: Perforation
timeFrame: 1 month
measure: Acute cholangitis
timeFrame: 1 month
measure: Operation time
timeFrame: 1 month
measure: Secondary treatment rate
timeFrame: 1 month
measure: Hospital stay
timeFrame: 1 month
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
state: Gansu
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Xun Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lobo DN, Balfour TW, Iftikhar SY. Periampullary diverticula: consequences of failed ERCP. Ann R Coll Surg Engl. 1998 Sep;80(5):326-31.
citation: 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: 10.1007/s10620-014-3321-1. Epub 2014 Aug 20. No abstract available.
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. Clin Endosc. 2013 Nov;46(6):637-42. doi: 10.5946/ce.2013.46.6.637. Epub 2013 Nov 19.
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 Int. 2013 Aug;12(4):408-14. doi: 10.1016/s1499-3872(13)60063-6.
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.