Clinical Trials/Other Resources
The textbook, Endosonography, edited by Drs. Hawes, Fockens and Varadarajulu, is dedicated to EUS education and is the most widely read textbook on EUS in the world. The book also has an online component in which literature review is posted on a quarterly basis.
Research at The Center for Interventional Endoscopy
Active Clinical Trials
1. Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Symptomatic Walled-Off Pancreatic Necrosis
Primary aim: To identify the optimal interventional approach for treatment of symptomatic or infected walled off pancreatic necrosis with lower incidence of major complications and mortality compared to minimally invasive surgical necrosectomy.
Walled off pancreatic necrosis
- Symptomatic: Pain, gastric outlet, intestinal or biliary obstruction, new-onset or persisting organ failure, or ‘persisting unwellness’.
- Infected (suspected and confirmed): clinical signs of infection (septic, positive blood cultures, febrile), systemic inflammatory response syndrome, gas within the collection on imaging (not iatrogenic), or positive culture of collection contents
- Necrotic collection has developed a wall, typically around 4 weeks post presentation, and is within 15mm of the lumen of the gastrointestinal tract.
- Informed consent obtained from the patient or their LAR.
- > 18 years old
- Medically fit for general anesthesia.
- Collection amenable to both endoscopic or minimally invasive surgical necrosectomy and drainage.
2. Randomized Trial Comparing Suction vs No Suction for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass Lesions Using 22G and 25G Needles
Primary aim: To compare the proportion of diagnostic cell block obtained during EUS-FNA of solid pancreatic mass lesions between 22G and 25G needles with and without suction.
- All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions that require FNA
- Age ≥ 19 years
3. Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
Primary aim: Compare the rates of complications in patients with pancreatic cancer undergoing preoperative biliary decompression using CSEMS or plastic stents.
- Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.
- Patients 19 yrs of age and older
- Serum bilirubin > 2mg/dl
- CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).
4. Comparison of Onsite versus Offsite Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct
Primary aim: To compare the diagnostic accuracy between onsite and offsite assessment of cholangioscopy-guided bile duct tissue acquisition.
All patients referred to Florida Hospital Endoscopy Unit for assessment of bile duct masses that require cholangioscopy-guided biopsies.
5. Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
Primary aim: To evaluate the prophylactic administration of 5 days of Octreotide on reducing the risk of post duodenal EMR or Ampullectomy bleeding in patients with duodenal and ampullary adenomas.
- Duodenal or ampullary adenoma ≥ 10mm
- Duodenal or ampullary adenoma that is suitable for endoscopic mucosal resection.
- Medically fit for anesthesia, endoscopy and EMR
- Able to provide informed consent
- 18 years or older, male and female
6. Reduction in Symptomatic Esophageal Stricture Formation Post-Two Stage Complete Barrett’s Excision for High Grade Dysplasia or Early Adenocarcinoma with Short-Term Steroid Therapy: A Randomized, Double-Blinded, Placebo-Controlled, Multicenter Trial
Primary aim: To compare the rate of symptomatic esophageal strictures in patients receiving placebo versus oral prednisone.
- Histologically confirmed Barretts mucosa with HGD or early EAC (T1a, intramucosal adenocarcinoma).
- Circumferential Barretts mucosa, ≤C3 and ≤M5.
- The general health condition of the patient permits anesthesia for endoscopy.
- Patient is 18 years of age or older.
- Informed consent is obtained
7. Lipidomics, Proteomics, Micro RNAs and Volatile Organic Compounds Biomarkers in Bile and Serum in the Diagnosis of Malignant Biliary Strictures
Primary aim: To identify and evaluate proteomics, lipidomics, micro-RNAs and VOCs changes in blood and bile that may give specific indication of malignant cell metabolism in cancer. By extensive characterization of these tumor-specific changes, we aim to determine their usefulness as biomarkers in the early diagnosis of cancer.
Gender: Male or Female
- Age: ≥18years old
- Treatment: scheduled for clinical reason to undergo:
ERCP (Endoscopic retrograde cholangiopancreatography)
- Timeframe: consent process possible prior to procedural intervention
- Provenance: scheduled to receive treatment at CIE at Orlando
The EUS App
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