TissueLink Versus SEAMGUARD After Distal Pancreatectomy

Stopped early · Phase 4

Conditions studied: Distal Pancreatectomy

In brief

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.

Key facts

Study ID

NCT01051856

Run by

Mayo Clinic

People needed

68

Starts

2009-12-01

Expected to finish

2015-03-01

Last updated by the study team

2023-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age equal or above 18 years
• 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:
• Current immunosuppressive therapy
• Chemotherapy within 2 weeks before operation
• Bevacizumab (Avastin™) treatment not completed at least 6 weeks before operation
• Radiotherapy before operation
• Inability to follow the instructions given by the investigator
• Lack of compliance
• Persons unable or unwilling to give informed consent to participate in this study
• Pregnant women
• Prisoners
• Institutionalized individuals

Where it is running

• Massachusettes General Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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