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HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications (HYPAR)

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ClinicalTrials.gov Identifier: NCT02775227
Recruitment Status : Active, not recruiting
First Posted : May 17, 2016
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Ville Sallinen, Helsinki University Central Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreatic Fistula Pancreatic Neoplasms Drug: Hydrocortisone Drug: Pasireotide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: HYPAR Trial - Hydrocortisone vs Pasireotide in Reducing Pancreatic Fistula and Other Complications After Pancreatic Resection - a Prospective, Randomized, Controlled Trial
Actual Study Start Date : May 2016
Actual Primary Completion Date : January 2019
Estimated Study Completion Date : December 2029


Arm Intervention/treatment
Experimental: Hydrocortisone Drug: Hydrocortisone
Active Comparator: Pasireotide Drug: Pasireotide



Primary Outcome Measures :
  1. Comprehensive Complication Index [ Time Frame: 30 days postoperatively ]

Secondary Outcome Measures :
  1. Complications (Clavien-Dindo classification) [ Time Frame: 30 days postoperatively ]
  2. Postoperative pancreatic fistula (ISGPS-classification) [ Time Frame: 30 days postoperatively ]
  3. Postoperative delayed gastric emptying (ISGPS-classification) [ Time Frame: 30 days postoperatively ]
  4. Post-pancreatectomy hemorrhage (ISGPS-classification) [ Time Frame: 30 days postoperatively ]
  5. Length of hospital stay, days [ Time Frame: During hospital stay, on average 7-14 days ]
  6. Readmissions [ Time Frame: 30 days postoperatively ]

Other Outcome Measures:
  1. Number of patients receiving adjuvant therapy [ Time Frame: 6 months postoperatively ]
  2. Overall survival [ Time Frame: 10 years ]
  3. Disease free survival [ Time Frame: 10 years ]
  4. Disease specific survival [ Time Frame: 10 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775227


Locations
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Finland
Helsinki University Central Hospital
Helsinki, Finland
Sponsors and Collaborators
Helsinki University Central Hospital

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Responsible Party: Ville Sallinen, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02775227     History of Changes
Other Study ID Numbers: HYKS-190116
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Pancreatic Neoplasms
Pancreatic Fistula
Fistula
Pathological Conditions, Anatomical
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Digestive System Fistula
Pasireotide
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs