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The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy (PANDEX)

Primary Purpose

Pancreaticoduodenectomy

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexamethasone
Saline placebo
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreaticoduodenectomy focused on measuring Pancreaticoduodenectomy, Dexamethasone, Postoperative complications, Double-blind, Pragmatic, Superiority trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexamethasone

Saline placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2022
Last Updated
September 14, 2023
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05567094
Brief Title
The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy
Acronym
PANDEX
Official Title
The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 8, 2022 (Actual)
Primary Completion Date
September 14, 2023 (Actual)
Study Completion Date
September 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreaticoduodenectomy
Keywords
Pancreaticoduodenectomy, Dexamethasone, Postoperative complications, Double-blind, Pragmatic, Superiority trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Arm Title
Saline placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Saline placebo
Intervention Description
Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Primary Outcome Measure Information:
Title
The Comprehensive Complication Index (CCI)
Description
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.
Time Frame
Within 30 days after the operation
Secondary Outcome Measure Information:
Title
The incidence of major complications (Clavien-Dindo≥3)
Time Frame
30 days
Title
The incidence of postoperative pancreatic fistula (ISGPS classification)
Time Frame
30 days
Title
The incidence of postpancreatectomy acute pancreatitis (ISGPS classification)
Time Frame
30 days
Title
The incidence of infection (including wound infection and intra-abdominal abscess)
Time Frame
30 days
Title
Postoperative length of stay
Time Frame
1 day of discharge
Title
The incidence of relaparotomy
Time Frame
30 days
Title
Mortality
Time Frame
30 days
Title
Mortality
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ruijin Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35848748
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.
Results Reference
background
PubMed Identifier
28420629
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.
Results Reference
background
PubMed Identifier
33951362
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.
Results Reference
background
PubMed Identifier
27429037
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.
Results Reference
background
PubMed Identifier
34078591
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.
Results Reference
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The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

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