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

NCT ID: NCT05431517

Last Updated: 2022-09-14

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

9073 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2022-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pancreatic Stenting Pancreatic Stent Displacement

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non-migration group

Cases without migration after pancreatic stenting under ERCP.

Analysis of ERCP records

Intervention Type PROCEDURE

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.

Analysis of ERCP records

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liang-hao Hu, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Changhai Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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IREPS20220611

Identifier Type: -

Identifier Source: org_study_id

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