Pancreatic Duct Stenting to Prevent Postoperative Pancreatic Fistula (POPF) After Distal Pancreatectomy
|ClinicalTrials.gov Identifier: NCT02573389|
Recruitment Status : Suspended (lack of accrual due to competing study)
First Posted : October 9, 2015
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis||Device: Boston Scientific or Cook pancreatic duct stents||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study on the Effect of Transampullary Pancreatic Duct Stenting on Postoperative Pancreatic Fistula Rate After Distal Pancreatectomy|
|Actual Study Start Date :||December 4, 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2020|
No Intervention: Retrospective and prospective "non-stented"
Non-stented patients undergoing distal pancreatectomy retrospectively (2008-2015) and prospectively from 2015 to 2017.
Experimental: Prospective "stented"
Patients who undergo prophylactic pancreatic duct stenting prior to a distal pancreatectomy starting approximately September 2015.
Device: Boston Scientific or Cook pancreatic duct stents
Boston Scientific or Cook straight or pigtail pancreatic stents. Stent size depends on duct size (capacity). Pancreatic plastic stents are made primarily of polyethylene materials. Pancreatic stent sizes range from 2 to 25 cm in length and 3F to 11.5F in.
- Post-operative pancreatic fistula [ Time Frame: At 6 months when enrollment begins ]
Rate of post-operative pancreatic fistula will be evaluated at 6 months when enrollment begins. Early stop is determined under either of below conditions:
- Effect size is smaller than needed to reach statistical difference even if number of enrollment is completed in one year.
- Adverse events occurring from the pancreatic duct stenting itself, which include pseudocyst, delaying surgery, pancreatitis requiring prolonged hospital admission, or death.
- There is statistical significant difference between control and intervention groups.
- Pre-operative: Pancreatitis from pancreatic duct stent [ Time Frame: 1 - 2 weeks prior to distal pancreatectomy ]
- Postoperative: Abscess, hemorrhage, reoperation, pulmonary embolism, mortality [ Time Frame: 3 days post surgery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573389
|Principal Investigator:||Louis A DiFronzo, MD||Kaiser Permanente|