Working... Menu

TissueLink Versus SEAMGUARD After Distal Pancreatectomy (PLATS)

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. Identifier: NCT01051856
Recruitment Status : Terminated (The trial closed early due to poor accrual.)
First Posted : January 20, 2010
Results First Posted : June 12, 2015
Last Update Posted : July 15, 2015
Information provided by (Responsible Party):
Florencia G. Que, Mayo Clinic

Brief Summary:
The purpose of this research study is to find a lowest leak rate following a distal pancreatectomy (removal of the left side of the pancreas). Distal pancreatectomy is known to have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the pancreas). Two FDA cleared devices (TissueLink and SEAMGUARD) will be studied to treat and prevent leaks at the end of the pancreas.

Condition or disease Intervention/treatment Phase
Distal Pancreatectomy Device: SEAMGUARD with bioabsorbable staple Procedure: TissueLink with radiofrequency ablation Phase 4

Detailed Description:

The objective of this trial is to compare the effectiveness of TissueLink closure of pancreatic stump after distal pancreatectomy to that of SEAMGUARD reinforced stapler closure.

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. This complication prolongs in-patient and outpatient care and resulting in significant detriments to the patient's operative experience and increases in the financial burden of pancreatic surgery.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 2009
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Active Comparator: SEAMGUARD with bioabsorbable staple
In this arm pancreatic transection will be executed using an endoscopic linear stapling device. The individual staple depth can be chosen by the operating surgeon. Bioabsorbable Mesh sleeves specifically manufactured for the chosen staple depth and cartridge length will be placed over the stapler before firing.
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 with radiofrequency ablation
After pancreatic transection, with any method chosen by the operating surgeon, the pancreatic remnant will be treated with TissueLink alone for an ablation depth (thickness) of approximately 7 mm using electrosurgical generator settings of 100 W and a saline drip rate of 1-2 drops per second.
Procedure: TissueLink with 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.

Primary Outcome Measures :
  1. Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation [ Time Frame: 90 days from the operation ]
    Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection.

Secondary Outcome Measures :
  1. Severity of the Pancreatic Fistula Leaks [ Time Frame: 90 days post operative ]
    Grading of the clinical severity of the leak was done according to the International Study Group on Pancreatic Fistula criteria. Severity of fistula was reported as clinically significant (Grades B and C) or not (Grade A). Grade C indicates the most severe clinical outcome.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01051856

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Florencia G Que, M.D. S Mayo Clinic, Rochester, MN