## Protocol Section
### Identification Module
**NCT ID:** NCT05267379

**Acronym:** G-PEP

**Brief Title:** An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis

**Official Title:** An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis

#### Organization Study ID Info
**ID:** 108224
#### Organization
**Class:** OTHER
**Full Name:** Radboud University Medical Center
### Status Module
#### Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-11

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2022-03-04
**Type:** ACTUAL
**Study First Submit Date:** 2022-01-24
**Study First Submit QC Date:** 2022-02-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Radboud University Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Endoscopic retrograde cholangiopancreatography (ERCP) comes with a risk for post-ERCP pancreatitis (PEP), which accounts for considerable morbidity, high healthcare expenditure, and death. The pathophysiology of PEP and the underpinnings of the preventive effect of rectal NSAID (RN) is poorly understood. Guidelines advise to take preventive measures with a single dose of 100mg RN, peri-ERCP. While NSAID administration reduces the risk with 40%, PEP still occurs after ERCP. In addition, patients with a PEP history have a higher risk to develop recurrence after a subsequent ERCP. This might suggest that an underlying genetic risk may contribute to increasing the incidence of PEP in some patients.

**Detailed Description:** This study is a hypothesis driven and hypothesis free analyses of PEP risk variants. Integrative analysis of NSAID pharmacokinetics and-genetics in PEP patients.

### Conditions Module

**Conditions:**

- Post-ERCP Acute Pancreatitis

### Design Module

#### Bio Spec

**Description:** Blood samples

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 700

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients who develop PEP

**Intervention Names:**

- Diagnostic Test: Take blood samples

**Label:** PEP patients

#### Arm Group 2

**Description:** Patients who do not develop PEP

**Intervention Names:**

- Diagnostic Test: Take blood samples

**Label:** Control cohort

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control cohort

- PEP patients

**Description:** Blood samples are used to check for polymorphisms in NSAID metabolization genes and to determine the diclofenac levels.

**Name:** Take blood samples

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Analyzing differences in polymorphisms in NSAID metabolization genes between PEP patients and control patients using Taqman assay. DNA will be isolated from blood samples and analyzed for SNP's of biotransformation enzymes such as UDP-Glucuronosyltransferase-2B7 (UGT2B7) and CYP2C9. This will be done using polymerase chain reaction (PCR) with fluorescent probes specific for a SNP (Taqman assay)

**Measure:** Differences in SNP's in NSAID metabolization genes

**Time Frame:** 1 month

#### Secondary Outcomes

**Description:** Detection of diclofenac levels two hours after diclofenac administration. Levels will be measured in blood samples by high-performance liquid chromatography (HPLC).

**Measure:** Diclofenac levels

**Time Frame:** 2 hours

**Description:** To investigate whether there is a correlation between diclofenac levels and NSAID metabolism gene polymorphisms. Using an independent t-test, the investigators will try to find a significant correlation between the diclofenac levels and a difference in single nucleotide polymorphism (SNP).

**Measure:** Correlation diclofenac levels and NSAID metabolization gene polymorphisms

**Time Frame:** 1 month

**Description:** To investigate whether the known genes involved in developing acute pancreatitis also are involved in developing PEP. DNA isolated from the blood samples will be analyzed by Miniseq-technique.

**Measure:** Genes involved in development of PEP

**Time Frame:** 1 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age ≥ 18 years
* written informed consent
* Indication to undergo an ERCP

Exclusion Criteria:

* Pancreatic cancer
* Chronic pancreatitis
* Ongoing acute pancreatitis
* Altered anatomy, defined as anatomical variations in which gall and/or pancreatic juices (in case of pancreatic duct interventions) do not enter the duodenum by way of the ampulla of Vater.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients aged 18 years or older with an indication to undergo an ERCP, without pancreatic cancer, chronic pancreatitis, altered anatomy of the upper digestive tract and an ongoing acute pancreatitis.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mike.dejong@radboudumc.nl

**Name:** Mike de Jong, MD

**Phone:** 0031883207054

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nijmegen

**Contacts:**

***Contact 1:***

- **Email:** mike.dejong@radboudumc.nl

- **Name:** Mike de Jong, MD

- **Phone:** 0031883207054

- **Role:** CONTACT

***Contact 2:***

- **Email:** erwin.vangeenen@radboudumc.nl

- **Name:** Erwin van Geenen, MD, PhD

- **Phone:** 0031243619190

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** RadboudUMC

**State:** Gelderland

**Status:** RECRUITING

**Zip:** 6525 GA

#### Overall Officials

**Official 1:**

**Affiliation:** Radboud University Medical Center

**Name:** Erwin van Geenen, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** The dataset used during this study is available from the corresponding author upon reasonable request.

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13115

- Name: Pancreatitis

- Relevance: HIGH

- As Found: Pancreatitis

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010195

- Term: Pancreatitis

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7197

- Name: Diclofenac

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
