TissueLink Versus SEAMGUARD After Distal Pancreatectomy

Distal Pancreatectomy Clinical Trial

— PLATS  

Official title:

A Multicenter Mayo-initiated Randomized Controlled Trial Comparing Pancreatic Leaks After TissueLink vs SEAMGUARD After Distal Pancreatectomy (PLATS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01051856
• Other study ID #: 09-000362
• Status: Terminated
• Phase: Phase 4
• Start date: December 2009
• Est. completion date: March 2015

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: March 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Pancreatectomy

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Massachusettes General Hospital	Boston	Massachusetts
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 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.	90 days from the operation
Secondary	Severity of the Pancreatic Fistula Leaks	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.	90 days post operative