EICHORCondition: Distal Pancreatectomy · Sponsor: Mayo Clinic
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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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Massachusettes General Hospital | Boston, Massachusetts, United States | — |
| Mayo Clinic | Rochester, Minnesota, United States | — |
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Source record: clinicaltrials.gov/study/NCT01051856