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Endoscopic Abraxane Injection Into Pancreatic Cysts

This study has been terminated.
(expiration of IRB approval)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01698710
First Posted: October 3, 2012
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
William R. Brugge, MD, Massachusetts General Hospital
Results First Submitted: May 26, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Cysts
Intervention: Drug: Albumin bound paclitaxel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Albumin Bound Paclitaxel

Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.

Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.


Participant Flow:   Overall Study
    Albumin Bound Paclitaxel
STARTED   5 
COMPLETED   5 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Albumin Bound Paclitaxel

Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.

Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.


Baseline Measures
   Albumin Bound Paclitaxel 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      1  20.0% 
>=65 years      4  80.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  40.0% 
Male      3  60.0% 
Region of Enrollment 
[Units: Participants]
 
United States   5 
Cyst diameter [1] 
[Units: Mm]
Mean (Full Range)
 28.4 
 (23 to 35) 
[1] Patients with clinically diagnosed mucinous cysts (premalignant or malignant cysts of the pancreas) including mucinous cystic neoplasms and intraductal papillary mucinous neoplasms were eligible.
Location of cyst [1] 
[Units: Participants]
Count of Participants
 
Head      4  80.0% 
Body      1  20.0% 
[1] Patients with clinically diagnosed mucinous cysts (premalignant or malignant cysts of the pancreas) including mucinous cystic neoplasms and intraductal papillary mucinous neoplasms were eligible.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Frequency of Pancreatitis   [ Time Frame: 3-10 months (median 6 months) after injection therapy ]

2.  Secondary:   Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts   [ Time Frame: immediately after procedure ]

3.  Secondary:   Size of Cystic Lesion   [ Time Frame: 3-10 months (median 6 months) after injection therapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. William Brugge
Organization: Massachusetts General Hospital
phone: 6173083532
e-mail: Brugge.William@mgh.harvard.edu



Responsible Party: William R. Brugge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01698710     History of Changes
Other Study ID Numbers: 12-178
First Submitted: October 1, 2012
First Posted: October 3, 2012
Results First Submitted: May 26, 2017
Results First Posted: June 21, 2017
Last Update Posted: June 21, 2017