NCT03492151: CLIMB

Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions

Recruiting now Last updated 22 August 2025

What this trial tests

trial in Pancreatic Cyst in 500 participants. Currently enrolling.

Timeline

1 October 2018

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Ohio State University Comprehensive Cancer Center
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	500
Start date	1 October 2018
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	10 locations across United States

Conditions studied

• Pancreatic Cyst — all drugs for Pancreatic Cyst →

Sponsor

Ohio State University Comprehensive Cancer Center

Who can join

18 and older, any sex, with Pancreatic Cyst. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold standard" for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Accuracy and agreement of a large panel of endosonographers for endomicroscopy-guided virtual biopsy of pancreatic cystic lesions.
   Machicado JD, Napoleon B, Lennon AM, El-Dika S, et al · · 2022 · cited 22× · PMID 36089484 · DOI 10.1016/j.pan.2022.08.012
2. Structured training program on confocal laser endomicroscopy for pancreatic cystic lesions: a multicenter prospective study among early-career endosonographers (with video).
   Machicado JD, Napoleon B, Akshintala V, Bazarbashi AN, et al · · 2023 · cited 6× · PMID 37473969 · DOI 10.1016/j.gie.2023.07.019
3. Towards automating risk stratification of intraductal papillary mucinous Neoplasms: Artificial intelligence advances beyond human expertise with confocal laser endomicroscopy.
   Krishna SG, Abdelbaki A, Li Z, Culp S, et al · · 2025 · cited 4× · PMID 40447463 · DOI 10.1016/j.pan.2025.05.011
4. Interobserver agreement in dysplasia grading of intraductal papillary mucinous neoplasms: performance of Kyoto guidelines and optimization of endomicroscopy biomarkers through pathology reclassification.
   Leupold M, Chen W, Esnakula AK, Frankel WL, et al · · 2025 · cited 4× · PMID 39557199 · DOI 10.1016/j.gie.2024.11.023
5. Artificial Intelligence Advances Digital Pathomics for Confocal Endomicroscopy Diagnosis of Pancreatic Cysts.
   Abdelbaki A, Li Z, Pan TY, Lee J, et al · · 2025 · cited 1× · PMID 41312297 · DOI 10.1016/j.tige.2025.250924
6. Endoscopic ultrasound-guided confocal endomicroscopy requires high-quality imaging and interpretation for diagnostic evaluation of pancreatic cystic lesions.
   Krishna SG. · · 2020 · cited 1× · PMID 32118104 · DOI 10.1055/a-1067-4595