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Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography

Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03550768
Enrollment
658
Registered
2018-06-08
Start date
2018-05-07
Completion date
2019-04-30
Last updated
2019-12-26

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

Conditions

Endoscopic Retrograde Cholangiopancreatography, Pancreaticobiilary Diseases

Keywords

ERCP, anatomy of major duodenal papilla

Brief summary

Selective cannulation is an essential step for the success of ERCP. The successful cannulation is influenced by types of disease (such as Sphincter of Oddi Dysfunction and duodenal stricture), the experience of endoscopists and the anatomy of papilla. It is suggested that the size, morphology, orientation and location of major duodenal papilla (MDP), could cause a difficult cannulation (Endoscopy 2016; 48: 657-683). However, the related evidences are limited. The investigators hypothesized that special anatomy of papilla, such as a lanky shape (defined by the higher ratio of length to width) and a deeper location, could increase the difficulty of cannulation. Here the investigators investigated the effects of the anatomy of major duodenal papilla on post-ERCP pancreatitis and the procedure of cannulation in patients undergoing ERCP.

Interventions

OTHERMDP

evaluate the anatomy of each major duodenal papilla before selective cannulation during ERCP

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
CollaboratorOTHER
Huaihe Hospital of Henan University
CollaboratorOTHER
Successful Hospital of Xiamen university
CollaboratorUNKNOWN
Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* age 18-80 * Patients with native papilla who underwent ERCP

Exclusion criteria

* Prior endoscopic sphincterotomy * Minor pancreatic duct as the targeted duct * History of prior upper gastrointestinal surgery, such as Billroth I, II and Roux-en-Y * Fistula of MDP * Papillary carcinoma or adenoma * Duodenal obstruction, type II * Prior stent placement in common bile duct or pancreatic duct * Pregnant or breastfeeding women * Unwilling or inability to provide consent

Design outcomes

Primary

MeasureTime frameDescription
post-ERCP pancreatitis incidence48 hoursfrequency of post-ERCP pancreatitis

Secondary

MeasureTime frameDescription
Rate of difficult cannulation3 hoursdifficult cannulation was defined as when total cannulation time was more than 5minutes, total cannulation attempts more than 5 times or inadvertent pancreatic duct cannulation more than 1 time.
Cannulation attempts3 hoursthe sphincterotome touching the papilla for at least 5 seconds will be considered as one attempt.
Total cannulation time3 hoursthe time from the moment the sphincterotome touch the papilla to the guide wire advance into the target duct.
Unintended pancreatic duct cannulation3 hoursthe guide wire unintentionally entered into the undesired pancreatic duct
Complication rate48 hoursfrequency of any adverse outcome that required hospital admission or prolonged hospital stay necessary for management of the complication, including pancreatitis, bleeding, biliary infection or perforation.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026