Incidence, Risk Factors and Endoscopic Retrieval of Proximally Migrated Pancreatic Stents

Incidence, Risk Factors and Endoscopic Retrieval of Proximally Migrated Pancreatic Stents: 25 Years of Experience in a Tertiary Center

This study intends to determine the incidence, risk factors and endoscopic treatment of proximally migrated pancreatic stents.

Study Overview

• Status: Completed
• Conditions: Pancreatic Stenting; Pancreatic Stent Displacement
• Intervention / Treatment: Procedure: Analysis of ERCP records

Detailed Description

Endoscopic pancreatic stenting can be used to treat a variety of pancreatic disorders, including chronic pancreatitis-induced pancreatic duct stenosis, pancreatic schizophrenia, pancreatic leakage, pancreatic pseudocyst drainage, and prophylactic pancreatic duct stenting. Postoperative stent migration is one of the complications associated with pancreatic stent placement.

In this retrospective study, more than 9,000 Endoscopic retrograde cholangiopancreatography (ERCP) cases at our center over the past 25 years will be analyzed to determine the incidence, risk factors and endoscopic treatment of proximally migrated pancreatic stents.

• Study Type: Observational
• Enrollment (Actual): 9073

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200433
    • Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with placements of pancreatic stents under ERCP.

Description

Inclusion Criteria:

• Pancreatic stent placement under ERCP;
• Pancreatic stent migration found by ERCP;
• Displaced pancreatic stent removal by ERCP technique.

Exclusion Criteria:

• Incomplete ERCP records (e.g., missing stent size information);
• Immediate removal of pancreatic stent following implantation for a variety of reasons.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-migration group; Cases without migration after pancreatic stenting under ERCP.	Procedure: Analysis of ERCP records; Data will be extracted from ERCP records of stenting, mainly including: 1) Age at the time of ERCP; 2) Gender; 3) Indication; 4) Papilla selection (major or minor); 5) Whether endoscopic sphincterotomy (EST) was performed; 6) Presence of nipple diverticulum; 7) Morphology of the pancreatic duct; 8) Status of pancreatic duct stones; 9) Number, shape, material, diameter and length of the stent; and 10) Operation of the bile duct. Additional data were extracted from the pertinent ERCP records of stent migration: 1) Shape, material, diameter and length of the displaced stent; 2) Type of migration; and 3) Removal tools.
Migration group; Cases with migration after pancreatic stenting under ERCP.	Procedure: Analysis of ERCP records; Data will be extracted from ERCP records of stenting, mainly including: 1) Age at the time of ERCP; 2) Gender; 3) Indication; 4) Papilla selection (major or minor); 5) Whether endoscopic sphincterotomy (EST) was performed; 6) Presence of nipple diverticulum; 7) Morphology of the pancreatic duct; 8) Status of pancreatic duct stones; 9) Number, shape, material, diameter and length of the stent; and 10) Operation of the bile duct. Additional data were extracted from the pertinent ERCP records of stent migration: 1) Shape, material, diameter and length of the displaced stent; 2) Type of migration; and 3) Removal tools.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of proximally migrated pancreatic stents	Within 1 month after data analysis
Success rate of endoscopic removal of migrated pancreatic stents	Within 1 month after data analysis

Collaborators and Investigators

• Sponsor: Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: June 19, 2022
• First Submitted That Met QC Criteria: June 19, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Endoscopic retrograde cholangiopancreatography
• Other Study ID Numbers: IREPS20220611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No