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.

 

CIE Annual Report 2016

CIE Annual Report 2015 

CIE Annual Report 2014 

 

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.

Inclusion criteria:

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.

Inclusion criteria:

  • 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.

 Inclusion Criteria: 

  • 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.

 Inclusion Criteria

             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.

Inclusion Criteria 

  • 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.

Inclusion criteria

  • 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. 


Inclusion Criteria 

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 

Procedures

Understanding Endoscopic Ultrasonography

Understanding Endoscopic Mucosal Resection

Understanding Endoscopic Retrograde

Understanding Pancreatic Cysts

 


The EUS App








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