PancreaticoduodenectomyPhase 4PANDEXNCT05567094
The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy
A Phase 4 study testing Dexamethasone in people with Pancreaticoduodenectomy, run by Ruijin Hospital at 1 site in China.
Trial summary
The primary objective of this clinical trial is evaluate the effect of dexamethasone on postoperative complications after pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreaticoduodenectomy
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2022to 14 Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
The primary objective of this clinical trial is evaluate the effect of dexamethasone on postoperative complications after pancreaticoduodenectomy.
Read the 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 .
- Conditions
- Pancreaticoduodenectomy
- Being tested
- Dexamethasone, Saline placebo
- Keywords
- Pancreaticoduodenectomy, Dexamethasone, Postoperative complications, Double-blind, Pragmatic, Superiority trial
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Saline placeboDrug
Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia Receives: Drug: Dexamethasone |
| Saline placebo | Placebo comparator | Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia Receives: Drug: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days after the operation
Secondary outcomes (8)
The incidence of major complications (Clavien-Dindo≥3)
Measured: 30 days
The incidence of postoperative pancreatic fistula (ISGPS classification)
Measured: 30 days
The incidence of postpancreatectomy acute pancreatitis (ISGPS classification)
Measured: 30 days
The incidence of infection (including wound infection and intra-abdominal abscess)
Measured: 30 days
Postoperative length of stay
Measured: 1 day of discharge
The incidence of relaparotomy
Measured: 30 days
Mortality
Measured: 30 days
Mortality
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start8 Oct 2022
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BAIYONG SHEN, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567094
- Sponsor's protocol ID
- PANDEX-1
- Acronym
- PANDEX
- Status last verified
- Sep 2023
- First submitted
- 30 Sep 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35848748DREAMS 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.
PubMed 28420629Corcoran 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.
PubMed 33951362Laaninen 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.
PubMed 27429037Asehnoune 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.
PubMed 34078591Chen 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.
PubMed 37660052
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT05567094
- Acronym / sponsor ID
- PANDEX / PANDEX-1
- Conditions
- Pancreaticoduodenectomy
- Keywords
- Pancreaticoduodenectomy, Dexamethasone, Postoperative complications, Double-blind, Pragmatic, Superiority trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasonePatients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia |
| Saline placebo | Placebo comparator | Drug: Saline placeboPatients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasonePatients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia | Drug | Dexamethasone |
| Saline placeboPatients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia | Drug | Saline placebo |
Primary outcome
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.
8 secondary outcomes
The incidence of major complications (Clavien-Dindo≥3)
Time frame: 30 days
The incidence of postoperative pancreatic fistula (ISGPS classification)
Time frame: 30 days
The incidence of postpancreatectomy acute pancreatitis (ISGPS classification)
Time frame: 30 days
The incidence of infection (including wound infection and intra-abdominal abscess)
Time frame: 30 days
Postoperative length of stay
Time frame: 1 day of discharge
The incidence of relaparotomy
Time frame: 30 days
Mortality
Time frame: 30 days
Mortality
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Background: PubMed 35848748Chen 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.
- Background: PubMed 28420629DREAMS 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.
- Background: PubMed 33951362Corcoran 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.
- Background: PubMed 27429037Laaninen 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.
- Background: PubMed 34078591Asehnoune 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.
- Derived from this study: PubMed 37660052Chen 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.
- Individual participant dataSharing planned: No
Related trials for Pancreaticoduodenectomy
Not yet recruitingObservational study
Endoscopic Papillectomy Versus Surgery for Ampullary Tumors: A Prospective Multicenter Cohort Study
Ampullary Neoplasm, Ampullary Adenoma
Recruiting
Stereotactic Body Radiotherapy (SBRT) Induced Pancreatic Atrophy for Prevention of Post Operative Pancreatic Fistulae (POPF) After Pancreatoduodenectomy in Very High-Risk Patients (STEREOPANC)
Pancreatic Surgery, Prophylactic SBRT
Not yet recruitingObservational study
Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy
Pancreaticoduodenectomy
Recruiting
Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
Pancreatic Cancer, Periampullary Cancer
RecruitingPhase 3
Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer
Pancreas Cancer, Periampullary Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Pancreaticoduodenectomy, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Comprehensive Complication Index (CCI) (time frame: Within 30 days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05567094, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.