The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

NCT05567094 | Completed Phase 4 DMC

• 1 other identifier: PANDEX-1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreaticoduodenectomy

Keywords

Pancreaticoduodenectomy; Dexamethasone; Postoperative complications; Double-blind; Pragmatic; Superiority trial

Outcome Measures

Primary Outcomes (1)

• The Comprehensive Complication Index (CCI)

  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.

  Within 30 days after the operation

Secondary Outcomes (8)

• 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

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Saline placebo

PLACEBO COMPARATOR

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

Drug: Saline placebo

Interventions

Dexamethasone DRUG

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

Dexamethasone

Saline placebo DRUG

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

Saline placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (6)

• Chen H, Wang C, Shen Z, Wang W, Weng Y, Ying X, Deng X, Shen B. Postpancreatectomy Acute Pancreatitis After Pancreaticoduodenectomy: A Distinct Clinical Entity. Ann Surg. 2023 Aug 1;278(2):e278-e283. doi: 10.1097/SLA.0000000000005605. Epub 2022 Jul 18.

  PMID: 35848748 BACKGROUND

• DREAMS Trial Collaborators and West Midlands Research Collaborative. Dexamethasone versus standard treatment for postoperative nausea and vomiting in gastrointestinal surgery: randomised controlled trial (DREAMS Trial). BMJ. 2017 Apr 18;357:j1455. doi: 10.1136/bmj.j1455.

  PMID: 28420629 BACKGROUND

• Corcoran TB, Myles PS, Forbes AB, Cheng AC, Bach LA, O'Loughlin E, Leslie K, Chan MTV, Story D, Short TG, Martin C, Coutts P, Ho KM; PADDI Investigators; Australian and New Zealand College of Anaesthetists Clinical Trials Network; Australasian Society for Infectious Diseases Clinical Research Network. Dexamethasone and Surgical-Site Infection. N Engl J Med. 2021 May 6;384(18):1731-1741. doi: 10.1056/NEJMoa2028982.

  PMID: 33951362 BACKGROUND

• Laaninen M, Sand J, Nordback I, Vasama K, Laukkarinen J. Perioperative Hydrocortisone Reduces Major Complications After Pancreaticoduodenectomy: A Randomized Controlled Trial. Ann Surg. 2016 Nov;264(5):696-702. doi: 10.1097/SLA.0000000000001883.

  PMID: 27429037 BACKGROUND

• Asehnoune K, Le Moal C, Lebuffe G, Le Penndu M, Josse NC, Boisson M, Lescot T, Faucher M, Jaber S, Godet T, Leone M, Motamed C, David JS, Cinotti R, El Amine Y, Liutkus D, Garot M, Marc A, Le Corre A, Thomasseau A, Jobert A, Flet L, Feuillet F, Pere M, Futier E, Roquilly A; PACMAN study group. Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial. BMJ. 2021 Jun 2;373:n1162. doi: 10.1136/bmj.n1162.

  PMID: 34078591 BACKGROUND

• Chen H, Wang Y, Wang C, Lu X, Li Y, Sun B, Jiang K, Qiu Y, Chen R, Cao L, Chen S, Luo Y, Shen B. The effect of perioperative of dexamethasone on postoperative complications after pancreaticoduodenectomy (PANDEX): a study protocol for a pragmatic multicenter randomized controlled trial. Trials. 2023 Sep 2;24(1):569. doi: 10.1186/s13063-023-07571-y.

  PMID: 37660052 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 5, 2022
• Study Start: October 8, 2022
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)