Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
NCT Number: NCT05567094
The primary objective of this clinical trial is evaluate the effect of dexamethasone on postoperative complications after pancreaticoduodenectomy.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 4
Shanghai, Shanghai Municipality, 200025, China
This is a multicentric, prospective, randomized, double-blind, pragmatic, placebo-control study. Patients who are going to receive elective pancreaticoduodenectomy will be randomized to receive 0.2 mg/kg dexamethasone or saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia. The primary outcome is the Comprehensive Complication Index (CCI) score within 30 days after the operation, which will be compared between these two groups .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Time frame: Within 30 days after the operation
The Comprehensive Complication Index (CCI) score within 30 days after the operation.
The CCI takes into account all cumulative complications and receives values between 0 and 100. The weight of complication (wC) of the CCI is based on the established Clavien-Dindo classification.
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 1 day of discharge
Time frame: 30 days
Time frame: 30 days
Time frame: 60 days
Ruijin Hospital
Other
Acronym: PANDEX
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.
Published trials that share one or more normalized conditions with this study.
NCT05042882
Malnutrition, Nutrition Disorders
Paris, France
View Trial DetailsNCT05680623
Digestive System Diseases, Digestive System Fistula
Verona, Italy
View Trial DetailsNCT01950845
Colorectal Surgery, Hepatectomy
Pierre-Bénite, France
View Trial DetailsNCT04171440
Pancreaticoduodenectomy
Baltimore, Maryland, United States
View Trial Details