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

Pancreatic Neoplasms Clinical Trial

— HYPAR  

Official title:

HYPAR Trial - Hydrocortisone vs Pasireotide in Reducing Pancreatic Fistula and Other Complications After Pancreatic Resection - a Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02775227
• Other study ID #: HYKS-190116
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 2016
• Est. completion date: December 2029

Study information

• Verified date: August 2020
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: December 2029
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula
• Pancreatic Neoplasms

Intervention

Drug:
• Hydrocortisone

• Pasireotide

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients receiving adjuvant therapy		6 months postoperatively
Other	Overall survival		10 years
Other	Disease free survival		10 years
Other	Disease specific survival		10 years
Primary	Comprehensive Complication Index		30 days postoperatively
Secondary	Complications (Clavien-Dindo classification)		30 days postoperatively
Secondary	Postoperative pancreatic fistula (ISGPS-classification)		30 days postoperatively
Secondary	Postoperative delayed gastric emptying (ISGPS-classification)		30 days postoperatively
Secondary	Post-pancreatectomy hemorrhage (ISGPS-classification)		30 days postoperatively
Secondary	Length of hospital stay, days		During hospital stay, on average 7-14 days
Secondary	Readmissions		30 days postoperatively