PANDEX: The Effect of Perioperative of DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05567094

Collaborator

(none)

300

Enrollment

Location

Arms

23.8

Anticipated Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this clinical trial is evaluate the effect of dexamethasone on postoperative complications after pancreaticoduodenectomy.

Condition or Disease	Intervention/Treatment	Phase
Pancreaticoduodenectomy	Drug: Dexamethasone Drug: Saline placebo	Phase 4

Detailed Description

This is a monocentric, prospective, randomized, double-blind, pragmatic, placebo-control, superiority 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 .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients 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.Patients 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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The patients, surgeons, anesthetists, data collectors, and outcome assessors are all blinded. Only the data manager and the specific study coordinator are unblinded to the group allocation.

Primary Purpose:

Prevention

Official Title:

The Effect of Perioperative of DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

Actual Study Start Date :

Oct 8, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia	Drug: Dexamethasone Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Placebo Comparator: Saline placebo Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia	Drug: Saline placebo Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Arm

Intervention/Treatment

Experimental: Dexamethasone

Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Drug: Dexamethasone

Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Placebo Comparator: Saline placebo

Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Drug: Saline placebo

Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Outcome Measures

Primary Outcome Measures

The Comprehensive Complication Index (CCI) [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.

Secondary Outcome Measures

The incidence of major complications (Clavien-Dindo≥3) [30 days]
The incidence of postoperative pancreatic fistula (ISGPS classification) [30 days]
The incidence of postpancreatectomy acute pancreatitis (ISGPS classification) [30 days]
The incidence of infection (including wound infection and intra-abdominal abscess) [30 days]
Postoperative length of stay [1 day of discharge]
The incidence of relaparotomy [30 days]
Mortality [30 days]
Mortality [60 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients ≥18 years of age;
An indication for elective PD surgery;
Patients understand the nature of this trial and are willing to comply;
Patients are able to provide written informed consent;

Exclusion Criteria:

Current or recent (within preceding 1 month) systemic use of glucocorticoids;
Distant metastases including peritoneal carcinomatosis, liver metastases, distant lymph node metastases, and involvement of other organs;
Patients may undergo left, central, or total pancreatectomy other than PD;
Palliative surgery；
Patients with high operative risk, as defined by the American Society of Anesthesiologists (ASA), with a score ≥ 4;
Synchronous malignancy in other organs or second cancer requiring resection during the same procedure;
Pregnant and lactating women.