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Active, Not Recruiting

NCT Number: NCT02775227

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatic Fistula Digestive System Diseases Digestive System Fistula Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fistula Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University Central Hospital

Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocortisone

Drug

Pasireotide

Drug

Primary outcomes

  1. Comprehensive Complication Index

    Time frame: 30 days postoperatively

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Acronym: HYPAR

Important dates

Study start
2016
Primary completion
2019
Study completion
2029
First posted
May 17, 2016
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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