This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

This study has been terminated.
(The 3rd interim analysis found superiority in the mesh reinforcement arm)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01359410
First received: May 20, 2011
Last updated: March 29, 2017
Last verified: March 2017
Results First Received: March 29, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Pancreatic Neoplasms
Interventions: Device: Mesh reinforced staple line (SEAMGUARD)
Device: Stapled without mesh reinforcement (PER-STRIPS DRY)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened to participant enrollment on 06/28/2007 and closed to participant enrollment on 10/28/2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
112 participants were enrolled to the study but 12 participants (1 participant declined to be in the study and 11 participants were found to be ineligible) were excluded from the study before randomization to the arms.

Reporting Groups
  Description
Stapled Transection With Mesh Reinforcement Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
Stapled Transection Without Mesh Reinforcement No text entered.

Participant Flow:   Overall Study
    Stapled Transection With Mesh Reinforcement   Stapled Transection Without Mesh Reinforcement
STARTED   54   46 
COMPLETED   54   46 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Stapled Transection With Mesh Reinforcement Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
Stapled Transection Without Mesh Reinforcement No text entered.
Total Total of all reporting groups

Baseline Measures
   Stapled Transection With Mesh Reinforcement   Stapled Transection Without Mesh Reinforcement   Total 
Overall Participants Analyzed 
[Units: Participants]
 54   46   100 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.5  (15.6)   58.6  (13.4)   58.0  (14.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      34  63.0%      21  45.7%      55  55.0% 
Male      20  37.0%      25  54.3%      45  45.0% 
Region of Enrollment 
[Units: Participants]
     
United States   54   46   100 
Indication for operation 
[Units: Participants]
Count of Participants
     
Adenocarcinoma      8  14.8%      10  21.7%      18  18.0% 
Neuroendocrine tumor      12  22.2%      14  30.4%      26  26.0% 
Metastatic tumor to pancreas      3   5.6%      3   6.5%      6   6.0% 
Benign pancreatic tumor      24  44.4%      13  28.3%      37  37.0% 
Chronic pancreatitis      3   5.6%      4   8.7%      7   7.0% 
Normal pancreas      4   7.4%      2   4.3%      6   6.0% 
Smoking history 
[Units: Participants]
Count of Participants
     
Nonsmoker      34  63.0%      26  56.5%      60  60.0% 
Smoker      20  37.0%      20  43.5%      40  40.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System   [ Time Frame: 100 days or removal of drain ]

2.  Secondary:   Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System   [ Time Frame: 100 days or removal of drain ]

3.  Secondary:   Time to Drain Removal   [ Time Frame: 100 days or removal of drain ]

4.  Secondary:   Number of Non-pancreatic Adverse Events   [ Time Frame: 100 days or removal of drain ]

5.  Post-Hoc:   Intraoperative Complications Incurred by Participants   [ Time Frame: 100 days or removal of drain ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
The investigators were unable to identify any complications directly due to the mesh materials. It is possible these complications are very rare and that the study did not include enough participants to potentially identify these potential harms.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: William Hawkins, M.D.
Organization: Washington University School of Medicine
phone: 314-362-7046
e-mail: hawkinsw@wustl.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01359410     History of Changes
Other Study ID Numbers: 06-1192
Study First Received: May 20, 2011
Results First Received: March 29, 2017
Last Updated: March 29, 2017