TissueLink Versus SEAMGUARD After Distal Pancreatectomy (PLATS)

This study has been terminated.
(The trial closed early due to poor accrual.)
Information provided by (Responsible Party):
Florencia G. Que, Mayo Clinic
ClinicalTrials.gov Identifier:
First received: January 15, 2010
Last updated: June 18, 2015
Last verified: June 2015

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 Intervention Phase
Distal Pancreatectomy
Device: SEAMGUARD with bioabsorbable staple
Procedure: TissueLink with 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:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Severity of the Pancreatic Fistula Leaks [ Time Frame: 90 days post operative ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 68
Study Start Date: December 2009
Study Completion Date: March 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01051856

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
Principal Investigator: Florencia G Que, M.D. S Mayo Clinic, Rochester, MN
  More Information

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
Results First Received: May 29, 2015
Last Updated: June 18, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 02, 2015