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TissueLink Versus SeamGuard After Distal Pancreatectomy (PLATS)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Florencia G. Que, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01051856
First received: January 15, 2010
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this research study is to find a lowest leak rate following a distal pancreatectomy (removal of the left side of your pancreas). Distal pancreatectomy is known to have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the pancreas). We are studying two FDA approved devices to treat and prevent leaks at the end of the pancreas. These two methods are Tissuelink and Seamguard. The study may help us understand which treatment will have a lower leak rate.


Condition Intervention Phase
Distal Pancreatectomy
 Device: Seamguard with bioabsorbable staple
Procedure: Tissuelink w/radiofrequency ablation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Multicenter Mayo-initiated Randomized Controlled Trial Comparing Pancreatic Leaks After TissueLink vs SeamGuard After Distal Pancreatectomy (PLATS)

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • The development of a postoperative pancreatic duct leak at the resection margin (pancreatic fistula) within 90 days from the operation. [ Time Frame: 90 days from the operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the severity of the leaks. [ Time Frame: 90 days post operative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: December 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Seamguard with bioabsorbable staple Device: Seamguard with bioabsorbable staple
In the Seamguard group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device
Active Comparator: Tissuelink w/radiofrequency ablation Procedure: Tissuelink w/radiofrequency ablation
After pancreatic transection with the method of choice of the operating surgeon the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm

Detailed Description:

The primary objective of this trial is to compare the effectiveness of Tissuelink closure of pancreatic stump after distal pancreatectomy to Seamguard.

The secondary objective of this trial is to compare the severity of leaks in the two groups using the ISGPF grading system.

Distal pancreatectomy is performed for a broad variety of indications including benign and malignant conditions. Specifically, distal pancreatectomy refers to resection of the portion of pancreas to the left of the superior mesenteric vein/portal vein trunk, excluding the duodenum and distal bile duct. Pancreatic duct leak at the resection margin is one of the most common complications of distal pancreatectomy prolonging inpatient and outpatient care and resulting in clinically important increases in the financial burden of pancreatic surgery.

Thus, a randomized, prospective, human trial comparing Tissuelink vs Seamguard may help us answer the question of which method is best to treat the pancreatic stump.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Age equal or above 18 years
  2. Accepted for elective distal pancreatectomy for any indication

Exclusion from randomization process:

  • Thickness of pancreas on preoperative CT scan images > 2.5 cm at the site of expected transection in anterior-posterior diameter. This will be reviewed by the surgeon the day before the surgeon sees the patient to predetermine the appropriateness of the patient for the study.

General study exclusion criteria:

  1. Current immunosuppressive therapy
  2. Chemotherapy within 2 weeks before operation
  3. Bevacizumab (Avastin™) treatment not completed at least 6 weeks before operation
  4. Radiotherapy before operation
  5. Inability to follow the instructions given by the investigator
  6. Lack of compliance
  7. Persons unable or unwilling to give informed consent to participate in this study
  8. Pregnant women
  9. Prisoners
  10. Institutionalized individuals
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051856

Locations
United States, Massachusetts
Massachusettes General Hospital
Boston, Massachusetts, United States, 02144
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Florencia G Que, M.D. S Mayo Clinic, Rochester, MN
  More Information

No publications provided

Responsible Party: Florencia G. Que, MD S, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01051856     History of Changes
Other Study ID Numbers: 09-000362
Study First Received: January 15, 2010
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013