The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

Pancreaticoduodenectomy Clinical Trial

— PANDEX  

Official title:

The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05567094
• Other study ID #: PANDEX-1
• Status: Completed
• Phase: Phase 4
• Start date: October 8, 2022
• Est. completion date: September 14, 2023

Study information

• Verified date: September 2023
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 14, 2023
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreaticoduodenectomy
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The incidence of major complications (Clavien-Dindo=3)		30 days
Secondary	The incidence of postoperative pancreatic fistula (ISGPS classification)		30 days
Secondary	The incidence of postpancreatectomy acute pancreatitis (ISGPS classification)		30 days
Secondary	The incidence of infection (including wound infection and intra-abdominal abscess)		30 days
Secondary	Postoperative length of stay		1 day of discharge
Secondary	The incidence of relaparotomy		30 days
Secondary	Mortality		30 days
Secondary	Mortality		60 days