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EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm


Phase 1
18 Years
85 Years
Open (Enrolling)
Both
Mucinous Cystic Tumor With Moderate Dysplasia, Mucinous Cystadenoma of Pancreas, Mucinous Cystadenocarcinoma of Pancreas, Benign Neoplasm of Pancreas

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Trial Information

EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm


Inclusion Criteria:



1. Mucinous cystic neoplasm defined by cyst fluid analysis [23, 28]:

- CEA > 192ng/mL

- Amylase < 800 IU/L

- Cytology negative for malignant cells

- No communication of cyst with pancreatic duct on 2 imaging studies (EUS, CT,
MRCP, or ERCP)

2. Cyst size > 15mm but <50mm

3. 3 or fewer cyst compartments

4. Age ≥18 and ≤ 85

Exclusion Criteria:

1. Inability to safely undergo EUS examination with standard conscious sedation

2. Inability for safe FNA needle insertion into the cyst (eg: intervening vessel)

3. Inability to undergo MRI (metal implants/cardiac pacemaker/defibrillator,
claustrophobia)

4. Coagulopathy (INR>1.5 or platelets<50)

5. Active pancreatitis or pancreatic infection

6. Active sepsis/bacteremia

7. Inability to provide informed consent

8. Pregnancy

9. Breastfeeding women

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy: Cyst Resolution

Outcome Description:

Proportion of patients without cysts at 6 months

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Brian M Yan, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Western Ontario, Canada

Authority:

Canada: Health Canada

Study ID:

UWO18494

NCT ID:

NCT01525706

Start Date:

September 2012

Completion Date:

June 2017

Related Keywords:

  • Mucinous Cystic Tumor With Moderate Dysplasia
  • Mucinous Cystadenoma of Pancreas
  • Mucinous Cystadenocarcinoma of Pancreas
  • Benign Neoplasm of Pancreas
  • Endoscopic Ultrasound
  • Pancreatic Mucinous Cystic Neoplasm
  • Fine Needle Injection
  • Ethanol Ablation
  • Paclitaxel Ablation
  • Neoplasms
  • Cystadenocarcinoma
  • Cystadenoma
  • Cystadenoma, Mucinous
  • Pancreatic Neoplasms
  • Brain Neoplasms
  • Cystadenocarcinoma, Mucinous

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