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Completed

NCT Number: NCT05567094

The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

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 .

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Dexamethasone

Drug

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

Saline placebo

Drug

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

Primary outcomes

  1. The Comprehensive Complication Index (CCI)

    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.

Secondary outcomes

  1. The incidence of major complications (Clavien-Dindo≥3)

    Time frame: 30 days

  2. The incidence of postoperative pancreatic fistula (ISGPS classification)

    Time frame: 30 days

  3. The incidence of postpancreatectomy acute pancreatitis (ISGPS classification)

    Time frame: 30 days

  4. The incidence of infection (including wound infection and intra-abdominal abscess)

    Time frame: 30 days

  5. Postoperative length of stay

    Time frame: 1 day of discharge

  6. The incidence of relaparotomy

    Time frame: 30 days

  7. Mortality

    Time frame: 30 days

  8. Mortality

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Acronym: PANDEX

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2022
Registry last updated
Sep 18, 2023

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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