Clinical trial NCT05567094: The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy
Official title: The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreaticoduodenectomy
Keywords: Pancreaticoduodenectomy
Dexamethasone
Postoperative complications
Double-blind
Pragmatic
Superiority trial
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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

Detailed description: 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 .

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The Comprehensive Complication Index (CCI)
timeFrame: Within 30 days after the operation
Secondary outcomes:
measure: The incidence of major complications (Clavien-Dindo≥3)
timeFrame: 30 days
measure: The incidence of postoperative pancreatic fistula (ISGPS classification)
timeFrame: 30 days
measure: The incidence of postpancreatectomy acute pancreatitis (ISGPS classification)
timeFrame: 30 days
measure: The incidence of infection (including wound infection and intra-abdominal abscess)
timeFrame: 30 days
measure: Postoperative length of stay
timeFrame: 1 day of discharge
measure: The incidence of relaparotomy
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Mortality
timeFrame: 60 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.