Utility of EUS-guided Microbiopsies in Pancreatic Cystic Lesions

NCT03578445 | Completed

• 1 other identifier: H-17031060
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine clinical impact of EUS-guided microbiopsy procedure and supplementary molecular analyses compared to standard diagnostic workup of pancreatic cysts. The hypothesis is that a combination of previously mentioned modalities may change the management of some pancreatic cystic lesions, increase the diagnostic accuracy and optimize the discrimination between high- and low-risk pancreatic cysts.

Conditions

Pancreatic Cyst; IPMN; Mucinous Cyst; Pancreatic Adenocarcinoma

Keywords

EUS; EUS-FNA; microbiopsy

Outcome Measures

Primary Outcomes (1)

• Clinical impact of EUS-guided microbiopsies in patients with pancreatic cystic lesions

  All patients are evaluated at a multidisciplinary conference prior to microbiopsy procedure. A primary decision is made based on available imaging modalities and/or cyst fluid analysis (operation, follow-up or discontinuation from follow-up). Subsequently, each patient is once again evaluated at a multidisciplinary conference, and a possible change in management is noted. Clinical impact is defined as a proportion of the patients where a change in clinical management is observed.

  3 weeks

Secondary Outcomes (5)

• Technical success of EUS-guided microbiopsy procedure

  3 weeks

• Adverse events following EUS-guided microbiopsy procedure

  3 weeks

• Diagnostic yield of EUS-guided microbiopsies

  3 weeks

• Diagnostic performance of EUS-guided microbiopsies in the surgical subcohort

  2 years

• Diagnostic values of gene mutations (NGS analyses) in microbiopsy material in the surgical subcohort

  2 years

Study Arms (1)

Patients with a pancreatic cystic lesion

EXPERIMENTAL

Device: EUS-guided microbiopsy; Diagnostic Test: Next Generation Sequencing

Interventions

EUS-guided microbiopsy DEVICE

Use of EUS-guided through-the-needle microbiopsy forceps for obtainment of tissue from the wall of the cystic lesion

Also known as: Moray

Patients with a pancreatic cystic lesion

Next Generation Sequencing DIAGNOSTIC_TEST

Prevalence of genetic mutations in known cancer-associated genes in the microbiopsy tissue examined using the Ion AmpliSeq Cancer Hotspot Panel v2 (Life Technologies, Carlsbad, USA). The multigene panel explores selected regions of 50 cancer-associated genes, among others KRAS, GNAS, CDKN2A and SMAD4 genes.

Also known as: NGS

Patients with a pancreatic cystic lesion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years old or above
• Able to provide informed consent
• Pancreatic cyst with a diameter of 15 mm or above OR pancreatic cyst of any size with any one of either high-risk stigmata or worrisome features (obstructive jaundice in patients with a cyst in the head of the pancreas, solid component/mural nodule, thickened/enhancing cyst wall, main pancreatic duct ≥ 10 mm or abrupt change of main pancreatic duct diameter with distal atrophy)

You may not qualify if:

• Lactating and pregnant females
• Cystic lesions with a predominantly solid component, suspected of malignancy
• Patients with uncorrected coagulopathy (international normalized ratio \> 1.5 or platelet count \< 50 109/L)
• Patients with previous history of pancreatic cancer
• Patients with a history of major stomach surgery (e.g. Billroth 1 and 2, gastrectomy, gastric bypass, esophagectomy, resection of the liver or pancreas)
• Patients with disseminated malignant disease
• Patients unfit for surgery
• Patients where EUS-guided puncture of the lesion is not presumed technically feasible and/or safe
• Patients with systemic immunosuppressive disease or receiving systemic immunosuppressive treatment
• Patients with a history of recent pancreatitis (within 3 months)

Sponsors & Collaborators

• Herlev Hospital: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Gastro Unit, Division of Endoscopy

Herlev, Danmark, 2730, Denmark

Location

Related Publications (1)

• Rift CV, Melchior LC, Kovacevic B, Klausen P, Toxvaerd A, Grossjohann H, Karstensen JG, Brink L, Hassan H, Kalaitzakis E, Storkholm J, Scheie D, Hansen CP, Lund EL, Vilmann P, Hasselby JP. Targeted next-generation sequencing of EUS-guided through-the-needle-biopsy sampling from pancreatic cystic lesions. Gastrointest Endosc. 2023 Jan;97(1):50-58.e4. doi: 10.1016/j.gie.2022.08.008. Epub 2022 Aug 12.

  PMID: 35964683 DERIVED

MeSH Terms

Conditions

Pancreatic Cyst; Mucocele

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: July 6, 2018
• Study Start: February 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)