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

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02775227
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 163
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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 1, 2016
• Actual Primary Completion Date: Jan 1, 2019
• Anticipated Study Completion Date: Dec 1, 2029

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Comprehensive Complication Index [30 days postoperatively]

Secondary Outcome Measures

1. Complications (Clavien-Dindo classification) [30 days postoperatively]

2. Postoperative pancreatic fistula (ISGPS-classification) [30 days postoperatively]

3. Postoperative delayed gastric emptying (ISGPS-classification) [30 days postoperatively]

4. Post-pancreatectomy hemorrhage (ISGPS-classification) [30 days postoperatively]

5. Length of hospital stay, days [During hospital stay, on average 7-14 days]

6. Readmissions [30 days postoperatively]

Other Outcome Measures

1. Number of patients receiving adjuvant therapy [6 months postoperatively]

2. Overall survival [10 years]

3. Disease free survival [10 years]

4. Disease specific survival [10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University Central Hospital	Helsinki		Finland

Sponsors and Collaborators

• Helsinki University Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ville Sallinen, MD, PhD, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT02775227
• Other Study ID Numbers: HYKS-190116
• First Posted: May 17, 2016
• Last Update Posted: Aug 24, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Pancreatic Neoplasms; Pancreatic Fistula; Fistula; Hydrocortisone; Pasireotide

Study Results

No Results Posted as of Aug 24, 2020