Clinical trial NCT01051856: TissueLink Versus SEAMGUARD After Distal Pancreatectomy
Official title: A Multicenter Mayo-initiated Randomized Controlled Trial Comparing Pancreatic Leaks After TissueLink vs SEAMGUARD After Distal Pancreatectomy (PLATS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Distal Pancreatectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation
timeFrame: 90 days from the operation
Secondary outcomes:
measure: Severity of the Pancreatic Fistula Leaks
timeFrame: 90 days post operative
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusettes General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Florencia G Que, M.D. S
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
citation: Shubert CR, Ferrone CR, Fernandez-Del Castillo C, Kendrick ML, Farnell MB, Smoot RL, Truty MJ, Que FG. A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856. J Surg Res. 2016 Nov;206(1):32-40. doi: 10.1016/j.jss.2016.06.034. Epub 2016 Jun 17.