Clinical trial NCT02775227: HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications
Official title: HYPAR Trial - Hydrocortisone vs Pasireotide in Reducing Pancreatic Fistula and Other Complications After Pancreatic Resection - a Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Pancreatic Fistula
Pancreatic Neoplasms
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pancreatic resections carry a high risk for complications, especially pancreatic fistula. Both hydrocortisone and pasireotide have been shown to be effective in reducing complications in earlier RCTs. The aim of this study is to compare the effectiveness and safety of these two drugs in preventing complications of pancreatic surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for pancreatic surgery (pancreaticoduodenectomy, distal pancreatectomy, enucleation, or other type of pancreatic resection)

Exclusion Criteria:

* Preoperative exclusion criteria:
* Atrophic pancreas and/or dilated pancreatic duct at the site of planned pancreatic transsection (applies only to patients undergoing pancreaticoduodenectomy)
* Total pancreatectomy planned
* Allergy or other contraindication for hydrocortisone or pasireotide
* Age \< 18 years
* No informed consent
* Intraoperative exclusion criteria:
* Pancreatic resection cancelled (e.g. disseminated cancer)
* Hard pancreas and/or dilated pancreatic duct discovered during operation (applies only to patients undergoing pancreaticoduodenectomy)
* Total pancreatectomy is performed

Primary outcomes:
measure: Comprehensive Complication Index
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Complications (Clavien-Dindo classification)
timeFrame: 30 days postoperatively
measure: Postoperative pancreatic fistula (ISGPS-classification)
timeFrame: 30 days postoperatively
measure: Postoperative delayed gastric emptying (ISGPS-classification)
timeFrame: 30 days postoperatively
measure: Post-pancreatectomy hemorrhage (ISGPS-classification)
timeFrame: 30 days postoperatively
measure: Length of hospital stay, days
timeFrame: During hospital stay, on average 7-14 days
measure: Readmissions
timeFrame: 30 days postoperatively
Other outcomes:
measure: Number of patients receiving adjuvant therapy
timeFrame: 6 months postoperatively
measure: Overall survival
timeFrame: 10 years
measure: Disease free survival
timeFrame: 10 years
measure: Disease specific survival
timeFrame: 10 years
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
References:
citation: Tarvainen T, Siren J, Kokkola A, Sallinen V. Effect of Hydrocortisone vs Pasireotide on Pancreatic Surgery Complications in Patients With High Risk of Pancreatic Fistula: A Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):291-298. doi: 10.1001/jamasurg.2019.6019.