This trial is active, not recruiting.

Condition distal pancreatectomy
Treatments seamguard with bioabsorbable staple, tissuelink w/radiofrequency ablation
Phase phase 4
Sponsor Mayo Clinic
Start date December 2009
End date July 2014
Trial size 400 participants
Trial identifier NCT01051856, 09-000362


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
(Active Comparator)
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
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 Outcomes

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

Secondary Outcomes

Assessment of the severity of the leaks.
time frame: 90 days post operative

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Multicenter Mayo-initiated Randomized Controlled Trial Comparing Pancreatic Leaks After TissueLink vs SeamGuard After Distal Pancreatectomy (PLATS)
Principal investigator Florencia G Que, M.D. S
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Mayo Clinic.