Pancreatic Cyst Ablation With a Monopolar Radiofrequency Ablation Probe

NCT ID: NCT04253249

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2020-12-19

Brief Summary

Pancreatic cysts (A cyst is a thin walled cavity containing fluid) were rarely reported previously, but have been on a rise due to advanced imaging for evaluating pancreatic lesions or other medical reasons has increased detection of pancreatic cysts. Study shows transformation of pancreatic cysts to be 10.8 for every 100,000 women and 13.8 for every 100,000 men.

Pancreatic cysts are divided in two groups; serous and mucinous. Serous cysts are thin walled cysts and are not associated with precancer. On the other hand, mucinous cysts have a tendency to progress to pancreatic cancer.

Radio frequency ablation (RFA) is an alternative method used for patients who could not or decided to not undergo surgical removal of the cyst. This study is a standard of care study and no changes in regards to the procedure scheduled with the physician will be changed.

Detailed Description

Pancreatic cysts were rarely reported previously, however, the increased use of advanced imaging techniques (mainly computerized topography and magnetic resonance imaging), for evaluating suspected pancreatic pathology or for other medical reasons has increased the detection of pancreatic cysts. Prevalence can range from 2.5-38% (1,3). These rates vary by patient's age and modality of imaging used (i.e: CT vs MRI). The rate of a malignant transformation in pancreatic cysts is not well known, however, very low. A study using the SEER data reported this rate to be 10.8 for every 100,000 women, or 13.8 for every 100,000 men with more than 85% of malignancies being detected in patient's age 40-84 years of age. (4) The most common histological type was adenocarcinoma, with mucinous producing tumors making about 4% of all adenocarcinomas detected. Pancreatic cysts are categorized under two major groups; serous and mucinous. Serous cystadenomas are thin walled cysts and are not associated with precancer. Mucinous cysts on the other hand have various diameters and contain viscous fluids which have the tendency to progress to pancreatic cancer. Radiofrequency ablation was recently proposed as an alternative for patients who could not or would not undergo surgical resection. In a recent study under the title "Endoscopic ultrasound guided radiofrequency ablation, for pancreatic cystic neoplasms and neuroendocrine tumors", eight patients with pancreatic cystic lesions were recruited for the study. Six patients had pancreatic cystic neoplasm. Post procedure imaging in 3-6 months showed complete resolutions of the cysts in 2 cases after using EUS RFA. No major complications were observed within 48 hours after the procedure, and two patients had mild abdominal pain which was resolved within 3 days after the surgery. (1) Management of pancreatic cysts includes surgical or non-surgical, or can be observational with repeat imaging. Management type depends on factors including pathologic features of the cyst on imaging (cyst size, enhancing cyst walls, duct size…etc), and the patient's ability to undergo surgery. Older patients with preexisting morbidities may not be eligible for a surgical resection, thus the use of endoscopic ultrasound interventions maybe appropriate. Endoscopic ultrasound guided radio frequency ablation has been used in treating certain pancreatic lesions, with a favorable pancreatic outcome (5)

Conditions

Treatment Related Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

-Adult (18-64 yrs), Geriatric (65+ yrs)

Exclusion Criteria

• Pregnant woman
• Neonates
• Children

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Othman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MOHAMED O. OTHMAN

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

H-38304

Identifier Type: -

Identifier Source: org_study_id