Pancreas CancerNCT05434520
Relieving the Bile Ducts Prior to Pancreatoduodenectomy
An observational study of Pancreas Cancer and Surgery-Complications, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy. A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Surgery-Complications, Biliary Fistula
- What is being tested?
- Preoperative biliary drainage (ERC og PTC-aided)
- Type of treatment
- Surgery or procedure
- How many people
- 722 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 1 Mar 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: All patients who had undergone pancreatoduodenectomy from January 1st, 2015 to September 31, 2021
Who may be able to join
- All patients who had undergone pancreatoduodenectomy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy.
A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021. Patients who had preoperative bile duct drainage were compared to patients without intervention. Type of interventions, complications and outcome after surgery were compared using univariate and multivariate analysis.
Read the detailed description
Obstructive jaundice is a common problem in pancreatic and periampullary tumors, but preoperative biliary drainage in patients with hyperbilirubinemia is still controversial. The aim of this retrospective cohort study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy.
A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021.
- Conditions
- Pancreas Cancer, Surgery-Complications, Biliary Fistula
- Being tested
- Preoperative biliary drainage (ERC og PTC-aided)
- Keywords
- pancreatoduodenectomy, complications, percutaneous transhepatic biliary drainage
- Medical subject headings
- Pancreatic Neoplasms, Biliary Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative biliary drainage (ERC og PTC-aided)Procedure or surgery
Placement of biliary stent (plastic, covered SEMS, uncovered SEMS) endoscopic by ERC or placement of plastic catheter by PTC
| Study group | Role | What they receive |
|---|---|---|
| Preoperative biliary drainage | Patients who had undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy Receives: Procedure: Preoperative biliary drainage (ERC og PTC-aided) | |
| No preoperative biliary drainage | Patients who had not undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complication score (Clavien-Dindo)
The prevalence of complications graded according to Clavien-Dindo score after pancreatoduodenectomy. Clavien-Dindo 0 is no complications, Clavien-Dindo 5 means complications resulting in mortality.
Measured: During hospital admission, median time 13 days, up to 390 days.
30-day Mortality
30-day mortality rate post-pancreatoduodenectomy
Measured: up to 30 days
90-day Mortality
90-day mortality rate post-pancreatoduodenectomy
Measured: up to 90 days
Length of Hospital Stay
Accumulated length of hospital stay from the admission day prior to pancreatoduodenectomy, till the day of discharge.
Measured: Days from admission until discharge, up to 390 days, median time 13 days
30-day Readmission
Prevalence of readmission within 30-days after discharge following pancreatoduodenectomy.
Measured: up to 30-days from hospital discharge
Secondary outcomes (3)
Complications following preoperative bile duct drainage
Prevalence of cholangitis, pancreatitis, iatrogenic perforation, post-procedural bleeding and post-procedural thrombosis
Measured: up to 7 days after bile duct drainage
Time from Bile Duct Drainage to Pancreatoduodenectomy
Time from Bile Duct Decompression to pancreatoduodenectomy.
Measured: Days from bile duct decompression to pancreatoduodenectomy, median time 32 days, up to 534 days
Histological Specimen
Histological diagnosis of the resection specimens divided in malignant (ductal adenocarcinoma, cholangiocarcinoma, papillary carcinoma, duodenal adenocarcinoma, neuroendocrine tumor, other pancreatic carcinoma, other malignancy in the pancreas) and benign (IPMN, other benign diseases).
Measured: Obtained within 21 days after resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Mar 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waqas Farooqui, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434520
- Sponsor's protocol ID
- PDPTC1
- Status last verified
- Jun 2022
- First submitted
- 28 May 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated and/or analyzed during the current study are not publicly available due to a restriction agreement with the Danish Data Protection Agency but are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relieving the Bile Ducts Prior to Pancreatoduodenectomy
- ClinicalTrials.gov ID
- NCT05434520
- Acronym / sponsor ID
- PDPTC1
- Conditions
- Pancreas Cancer, Surgery-Complications, Biliary Fistula
- Keywords
- pancreatoduodenectomy, complications, percutaneous transhepatic biliary drainage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 28 Jun 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 aim of this study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy.
A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021. Patients who had preoperative bile duct drainage were compared to patients without intervention. Type of interventions, complications and outcome after surgery were compared using univariate and multivariate analysis.
Detailed description
Obstructive jaundice is a common problem in pancreatic and periampullary tumors, but preoperative biliary drainage in patients with hyperbilirubinemia is still controversial. The aim of this retrospective cohort study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy.
A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative biliary drainage | – | Procedure: Preoperative biliary drainage (ERC og PTC-aided)Patients who had undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy |
| No preoperative biliary drainage | – | –Patients who had not undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients who had undergone pancreatoduodenectomy from January 1st, 2015 to September 31, 2021
Key inclusion criteria (1 listed)
- All patients who had undergone pancreatoduodenectomy
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Preoperative biliary drainage (ERC og PTC-aided)Placement of biliary stent (plastic, covered SEMS, uncovered SEMS) endoscopic by ERC or placement of plastic catheter by PTC | Procedure or surgery | Preoperative biliary drainage |
Primary outcome
Post-operative complication score (Clavien-Dindo)
Time frame: During hospital admission, median time 13 days, up to 390 days.
The prevalence of complications graded according to Clavien-Dindo score after pancreatoduodenectomy. Clavien-Dindo 0 is no complications, Clavien-Dindo 5 means complications resulting in mortality.
30-day Mortality
Time frame: up to 30 days
30-day mortality rate post-pancreatoduodenectomy
90-day Mortality
Time frame: up to 90 days
90-day mortality rate post-pancreatoduodenectomy
Length of Hospital Stay
Time frame: Days from admission until discharge, up to 390 days, median time 13 days
Accumulated length of hospital stay from the admission day prior to pancreatoduodenectomy, till the day of discharge.
30-day Readmission
Time frame: up to 30-days from hospital discharge
Prevalence of readmission within 30-days after discharge following pancreatoduodenectomy.
3 secondary outcomes
Complications following preoperative bile duct drainage
Time frame: up to 7 days after bile duct drainage
Time from Bile Duct Drainage to Pancreatoduodenectomy
Time frame: Days from bile duct decompression to pancreatoduodenectomy, median time 32 days, up to 534 days
Histological Specimen
Time frame: Obtained within 21 days after resection
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 28 Jun 2022.
- Individual participant dataSharing planned: Undecided. The datasets generated and/or analyzed during the current study are not publicly available due to a restriction agreement with the Danish Data Protection Agency but are available from the corresponding author on reasonable request.
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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?
An observational study of Pancreas Cancer and Surgery-Complications, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 1 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 28 Jun 2022. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Post-operative complication score (Clavien-Dindo) (time frame: During hospital admission, median time 13 days, up to 390 days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2022.