Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas

The main objective of this study is to determine how physicians make decisions regarding surveillance of Intraductal Papillary Mucinous Neoplasm's (IPMN) of the pancreas.

Study Overview

• Status: Completed
• Conditions: Surgery Risk Assessment

Detailed Description

The study will employ a survey design that poses physicians with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case.

This will be a double-blinded randomized survey study, featuring two arms. Providers will be randomized to either be provided with, or not provided with a risk stratification tool (DART-1) when presented with their clinical case vignettes.

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The Pancreatic Cancer Early Detection (PRECEDE) Consortium is an international, multi-institutional collaborative group of experts to increase survival for pancreatic cancer patients by improving early detection, screening, risk modeling and prevention for those with a heritable risk for pancreatic cancer, through a novel model of collaboration and data sharing.

The PACYFIC group is comprised of Dutch surgeons, gastroenterologists, oncologists, radiologists, radiotherapists, and pathologists. Their common interest is to improve the prognosis of patients with pancreatic cancer, by initiating and performing research, and organizing ongoing training.

Description

Inclusion Criteria:

• Membership in either the PACYFIC or PRECEDE consortiums
• Physician with expertise in the management of IPMN
• Able and willing to complete survey

Exclusion Criteria:

• Not a member of either the PACYFIC or PRECEDE consortiums
• Not a physician with expertise in the management of IPMN

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Vignettes with Risk Stratification Tool; Physicians will be posed with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. Participants in this arm will be provided a risk stratification tool (DART-1) when presented with their clinical case vignettes. The DART-1 is a 5-question tool which calculates the probability (%) of IPMNs without worrisome features or high-risk stigmata at diagnosis.
Vignettes without Risk Stratification Tool; Physicians will be posed with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. Participants in this arm will be not be provided a risk stratification tool when presented with their clinical case vignettes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Decisions to Stop Surveillance Imaging	Day 1
Number of Decisions to Continue Surveillance Imaging	Day 1

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Greg Sacks, MD, MPH, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): July 28, 2023

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms; Pancreatic Neoplasms; Neoplasms, Cystic, Mucinous, and Serous; Pancreatic Intraductal Neoplasms
• Other Study ID Numbers: 22-01227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Greg.Sacks@nyulangone.org. The statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Greg.Sacks@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

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