If Different Types of Periampullary Diverticula Affect ERCP Cannulation?

NCT ID: NCT03556072

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2018-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Intubation;Difficult

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Intradiverticular papilla (IDP) group

Routine ERCP, recording the endoscopic procedures and observing the intra- and post-operative parameters

Routine ERCP

Intervention Type OTHER

Juxtapapillary diverticulum (JPD) group

Routine ERCP, recording the endoscopic procedures and observing the intra- and post-operative parameters

Routine ERCP

Intervention Type OTHER

Interventions

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Routine ERCP

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role lead

Responsible Party

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Xun Li

professor,head of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xun Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hepatopancreatobiliary Surgery Institute of Gansu Province

Locations

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Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, China

Site Status

Countries

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China

References

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

Reference Type RESULT
PMID: 9849331 (View on PubMed)

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.

Reference Type RESULT
PMID: 25138902 (View on PubMed)

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.

Reference Type RESULT
PMID: 24340257 (View on PubMed)

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.

Reference Type RESULT
PMID: 23924499 (View on PubMed)

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.

Reference Type RESULT
PMID: 18818967 (View on PubMed)

Other Identifiers

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PAD affects ERCP cannulation

Identifier Type: -

Identifier Source: org_study_id

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