Pancreatic CancerPEARNCT04847297
Preoperative Biliary Drainage in Malignant Biliary Obstruction
An observational study of Pancreatic Cancer, run by University of Pecs.
Trial summary
The first alarming symptom of a malignancy of the pancreas or periampullary tumor can be obstructive jaundice (OJ). Pancreato-duodenectomy (PD) combined with oncological treatment can provide long disease-free survival in resectable cases. The literature regarding the preoperative biliary drainage is controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Preoperative drainage and pancreatoduodenectomy and Pancreatoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 353 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population will be patients diagnosed with malignant biliary obstruction who meet all the inclusion criteria but no exclusion criteria. All patients admitted with malignant biliary obstruction with- or without biliary intervention prior to the surgery in the participating hospitals will be assessed for eligibility
Who may be able to join
- Patients ≥ 18 years
- OJ of malignant origin (pancreatic head or periampullary tumor)
- Total bilirubin level ≥ 40 μmol per liter
- Signed written informed consent
Who cannot join
- Proved metastasis
- Irresectable tumor
- Neo-adjuvant chemotherapy
- Co-existing malignancy
- Pregnancy
- Patients not fit for resection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preoperative Biliary Drainage in Malignant Biliary Obstruction - an Observational Cohort Study
The first alarming symptom of a malignancy of the pancreas or periampullary tumor can be obstructive jaundice (OJ). Pancreato-duodenectomy (PD) combined with oncological treatment can provide long disease-free survival in resectable cases. The literature regarding the preoperative biliary drainage is controversial. The aim of this multicenter, prospective observational cohort study is to investigate the role of preoperative drainage, and to compare it with surgery alone.
- Conditions
- Pancreatic Cancer
- Being tested
- Preoperative drainage and pancreatoduodenectomy, Pancreatoduodenectomy
- Keywords
- pancreatic cancer, biliary drainage, pancreato-duodenectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative drainage and pancreatoduodenectomyProcedure or surgery
Preoperative biliary drainage before surgical removal of the tumor
PancreatoduodenectomyProcedure or surgery
Pancreatic tumor resection without previous preoperative biliary drainage
| Study group | Role | What they receive |
|---|---|---|
| Preoperative biliary drainage and pancreatoduodenectomy | Patients receiving preoperative biliary drainage before the removal of the tumor. Receives: Procedure: Preoperative drainage and pancreatoduodenectomy | |
| Pancreatoduodenectomy only | Patients undergoing only surgical intervention, without preoperative drainage. Receives: Procedure: Pancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of serious complications
rate of serious complications after preoperative biliary drainage and surgery
- Pancreatitis
- New onset of cholecystitis
- Cholangitis
- Perforation
- Hemorrhage after endoscopic retrograde cholangiopancreatography (ERCP)
- Related to stent
- Occlusion
- Need for exchange Related to surgery
- Pancreas anastomosis leakage
Measured: 120 days
rate of serious complications
rate of serious complications after preoperative biliary drainage and surgery defined as:
- Pancreatitis
- New onset of cholecystitis
- Cholangitis
- Perforation
- Hemorrhage after endoscopic retrograde cholangiopancreatography (ERCP)
- Related to stent
- Occlusion
- Need for exchange Related to surgery
- Pancreas anastomosis leakage
Measured: 120 days
Secondary outcomes (3)
Length of hospitalization
Length of hospitalization after biliary drainage and surgery
Measured: 120 days
Mortality
Rate of mortality among groups
Measured: 30 days
Mortality
Rate of mortality among the groups
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 353 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Szűcs, University of Pecs
- Investigators
- Péter Hegyi, Study chair, Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, HungaryÁkos Szűcs, Principal investigator, First Surgical Department of the University of Semmelweis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847297
- Sponsor's protocol ID
- 40393-10/2020/EÜIG
- Acronym
- PEAR
- Status last verified
- Apr 2021
- First submitted
- 20 Dec 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdeldayem H, Ghoneim E, Refaei AA, Abou-Gabal A. Obstructive jaundice promotes intestinal-barrier dysfunction and bacterial translocation: experimental study. Hepatol Int. 2007 Dec;1(4):444-8. doi: 10.1007/s12072-007-9018-1. Epub 2007 Sep 20.
PubMed 19669340Assimakopoulos SF, Scopa CD, Vagianos CE. Pathophysiology of increased intestinal permeability in obstructive jaundice. World J Gastroenterol. 2007 Dec 28;13(48):6458-64. doi: 10.3748/wjg.v13.i48.6458.
PubMed 18161914Kuzu MA, Kale IT, Col C, Tekeli A, Tanik A, Koksoy C. Obstructive jaundice promotes bacterial translocation in humans. Hepatogastroenterology. 1999 Jul-Aug;46(28):2159-64.
PubMed 10521960Ito Y, Bethea NW, Baker GL, McCuskey MK, Urbaschek R, McCuskey RS. Hepatic microcirculatory dysfunction during cholestatic liver injury in rats. Microcirculation. 2003 Oct;10(5):421-32. doi: 10.1038/sj.mn.7800208.
PubMed 14557825Abraham S, Szabo A, Kaszaki J, Varga R, Eder K, Duda E, Lazar G, Tiszlavicz L, Boros M, Lazar G Jr. Kupffer cell blockade improves the endotoxin-induced microcirculatory inflammatory response in obstructive jaundice. Shock. 2008 Jul;30(1):69-74. doi: 10.1097/SHK.0b013e31815dceea.
PubMed 18562926Kennedy JA, Clements WD, Kirk SJ, McCaigue MD, Campbell GR, Erwin PJ, Halliday MI, Rowlands BJ. Characterization of the Kupffer cell response to exogenous endotoxin in a rodent model of obstructive jaundice. Br J Surg. 1999 May;86(5):628-33. doi: 10.1046/j.1365-2168.1999.01114.x.
PubMed 10361183Minter RM, Fan MH, Sun J, Niederbichler A, Ipaktchi K, Arbabi S, Hemmila MR, Remick DG, Wang SC, Su GL. Altered Kupffer cell function in biliary obstruction. Surgery. 2005 Aug;138(2):236-45. doi: 10.1016/j.surg.2005.04.001.
PubMed 16153432Sheen-Chen SM, Chau P, Harris HW. Obstructive jaundice alters Kupffer cell function independent of bacterial translocation. J Surg Res. 1998 Dec;80(2):205-9. doi: 10.1006/jsre.1998.5467.
PubMed 9878315Kloek JJ, Heger M, van der Gaag NA, Beuers U, van Gulik TM, Gouma DJ, Levi M. Effect of preoperative biliary drainage on coagulation and fibrinolysis in severe obstructive cholestasis. J Clin Gastroenterol. 2010 Oct;44(9):646-52. doi: 10.1097/MCG.0b013e3181ce5b36.
PubMed 20142756N Shachiri DK, D Tonev, M Shishenkov. Hemostasiologic Changes during Hepatobiliary Surgery in Patients with Obstructive Jaundice: Pathophysiology and Clinical Considerations. The Internet Journal of Anesthesiology. 2010;28(1).
Betjes MG, Bajema I. The pathology of jaundice-related renal insufficiency: cholemic nephrosis revisited. J Nephrol. 2006 Mar-Apr;19(2):229-33.
PubMed 16736428Uslu A, Tasli FA, Nart A, Postaci H, Aykas A, Bati H, Coskun Y. Human kidney histopathology in acute obstructive jaundice: a prospective study. Eur J Gastroenterol Hepatol. 2010 Dec;22(12):1458-65. doi: 10.1097/MEG.0b013e32833f71f6.
PubMed 20881503Padillo J, Puente J, Gomez M, Dios F, Naranjo A, Vallejo JA, Mino G, Pera C, Sitges-Serra A. Improved cardiac function in patients with obstructive jaundice after internal biliary drainage: hemodynamic and hormonal assessment. Ann Surg. 2001 Nov;234(5):652-6. doi: 10.1097/00000658-200111000-00010.
PubMed 11685028Klinkenbijl JH, Jeekel J, Schmitz PI, Rombout PA, Nix GA, Bruining HA, van Blankenstein M. Carcinoma of the pancreas and periampullary region: palliation versus cure. Br J Surg. 1993 Dec;80(12):1575-8. doi: 10.1002/bjs.1800801227.
PubMed 7507785Trede M, Schwall G. The complications of pancreatectomy. Ann Surg. 1988 Jan;207(1):39-47. doi: 10.1097/00000658-198801000-00009.
PubMed 3276272
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Biliary Drainage in Malignant Biliary Obstruction - an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04847297
- Acronym / sponsor ID
- PEAR / 40393-10/2020/EÜIG
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, biliary drainage, pancreato-duodenectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 353 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Apr 2021 (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 first alarming symptom of a malignancy of the pancreas or periampullary tumor can be obstructive jaundice (OJ). Pancreato-duodenectomy (PD) combined with oncological treatment can provide long disease-free survival in resectable cases. The literature regarding the preoperative biliary drainage is controversial. The aim of this multicenter, prospective observational cohort study is to investigate the role of preoperative drainage, and to compare it with surgery alone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative biliary drainage and pancreatoduodenectomy | – | Procedure: Preoperative drainage and pancreatoduodenectomyPatients receiving preoperative biliary drainage before the removal of the tumor. |
| Pancreatoduodenectomy only | – | Procedure: PancreatoduodenectomyPatients undergoing only surgical intervention, without preoperative drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be patients diagnosed with malignant biliary obstruction who meet all the inclusion criteria but no exclusion criteria. All patients admitted with malignant biliary obstruction with- or without biliary intervention prior to the surgery in the participating hospitals will be assessed for eligibility
Key inclusion criteria (4 listed)
- Patients ≥ 18 years
- OJ of malignant origin (pancreatic head or periampullary tumor)
- Total bilirubin level ≥ 40 μmol per liter
- Signed written informed consent
Key exclusion criteria (6 listed)
- Proved metastasis
- Irresectable tumor
- Neo-adjuvant chemotherapy
- Co-existing malignancy
- Pregnancy
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 drainage and pancreatoduodenectomyPreoperative biliary drainage before surgical removal of the tumor | Procedure or surgery | Preoperative biliary drainage and pancreatoduodenectomy |
| PancreatoduodenectomyPancreatic tumor resection without previous preoperative biliary drainage | Procedure or surgery | Pancreatoduodenectomy only |
Primary outcome
rate of serious complications
Time frame: 120 days
rate of serious complications after preoperative biliary drainage and surgery 1. Pancreatitis 2. New onset of cholecystitis 3. Cholangitis 4. Perforation 5. Hemorrhage after endoscopic retrograde cholangiopancreatography (ERCP) 6. Related to stent 1. Occlusion 2. Need for exchange Related to surgery 7. Pancreas anastomosis leakage
rate of serious complications
Time frame: 120 days
rate of serious complications after preoperative biliary drainage and surgery defined as: 1. Pancreatitis 2. New onset of cholecystitis 3. Cholangitis 4. Perforation 5. Hemorrhage after endoscopic retrograde cholangiopancreatography (ERCP) 6. Related to stent 1. Occlusion 2. Need for exchange Related to surgery 7. Pancreas anastomosis leakage
3 secondary outcomes
Length of hospitalization
Time frame: 120 days
Mortality
Time frame: 30 days
Mortality
Time frame: 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Background: PubMed 19669340Abdeldayem H, Ghoneim E, Refaei AA, Abou-Gabal A. Obstructive jaundice promotes intestinal-barrier dysfunction and bacterial translocation: experimental study. Hepatol Int. 2007 Dec;1(4):444-8. doi: 10.1007/s12072-007-9018-1. Epub 2007 Sep 20.
- Background: PubMed 18161914Assimakopoulos SF, Scopa CD, Vagianos CE. Pathophysiology of increased intestinal permeability in obstructive jaundice. World J Gastroenterol. 2007 Dec 28;13(48):6458-64. doi: 10.3748/wjg.v13.i48.6458.
- Background: PubMed 10521960Kuzu MA, Kale IT, Col C, Tekeli A, Tanik A, Koksoy C. Obstructive jaundice promotes bacterial translocation in humans. Hepatogastroenterology. 1999 Jul-Aug;46(28):2159-64.
- Background: PubMed 14557825Ito Y, Bethea NW, Baker GL, McCuskey MK, Urbaschek R, McCuskey RS. Hepatic microcirculatory dysfunction during cholestatic liver injury in rats. Microcirculation. 2003 Oct;10(5):421-32. doi: 10.1038/sj.mn.7800208.
- Background: PubMed 18562926Abraham S, Szabo A, Kaszaki J, Varga R, Eder K, Duda E, Lazar G, Tiszlavicz L, Boros M, Lazar G Jr. Kupffer cell blockade improves the endotoxin-induced microcirculatory inflammatory response in obstructive jaundice. Shock. 2008 Jul;30(1):69-74. doi: 10.1097/SHK.0b013e31815dceea.
- Background: PubMed 10361183Kennedy JA, Clements WD, Kirk SJ, McCaigue MD, Campbell GR, Erwin PJ, Halliday MI, Rowlands BJ. Characterization of the Kupffer cell response to exogenous endotoxin in a rodent model of obstructive jaundice. Br J Surg. 1999 May;86(5):628-33. doi: 10.1046/j.1365-2168.1999.01114.x.
- Background: PubMed 16153432Minter RM, Fan MH, Sun J, Niederbichler A, Ipaktchi K, Arbabi S, Hemmila MR, Remick DG, Wang SC, Su GL. Altered Kupffer cell function in biliary obstruction. Surgery. 2005 Aug;138(2):236-45. doi: 10.1016/j.surg.2005.04.001.
- Background: PubMed 9878315Sheen-Chen SM, Chau P, Harris HW. Obstructive jaundice alters Kupffer cell function independent of bacterial translocation. J Surg Res. 1998 Dec;80(2):205-9. doi: 10.1006/jsre.1998.5467.
- Background: PubMed 20142756Kloek JJ, Heger M, van der Gaag NA, Beuers U, van Gulik TM, Gouma DJ, Levi M. Effect of preoperative biliary drainage on coagulation and fibrinolysis in severe obstructive cholestasis. J Clin Gastroenterol. 2010 Oct;44(9):646-52. doi: 10.1097/MCG.0b013e3181ce5b36.
- BackgroundN Shachiri DK, D Tonev, M Shishenkov. Hemostasiologic Changes during Hepatobiliary Surgery in Patients with Obstructive Jaundice: Pathophysiology and Clinical Considerations. The Internet Journal of Anesthesiology. 2010;28(1).
- Background: PubMed 16736428Betjes MG, Bajema I. The pathology of jaundice-related renal insufficiency: cholemic nephrosis revisited. J Nephrol. 2006 Mar-Apr;19(2):229-33.
- Background: PubMed 20881503Uslu A, Tasli FA, Nart A, Postaci H, Aykas A, Bati H, Coskun Y. Human kidney histopathology in acute obstructive jaundice: a prospective study. Eur J Gastroenterol Hepatol. 2010 Dec;22(12):1458-65. doi: 10.1097/MEG.0b013e32833f71f6.
- Individual participant dataSharing planned: No
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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.
Péter Hegyi study chair
Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary
Ákos Szűcs principal investigator
First Surgical Department of the University of Semmelweis
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by University of Pecs.
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 6 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: opening soon, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ákos Szűcs (06305359443, szucs.akos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of serious complications (time frame: 120 days). The study lists 2 primary outcomes in all. 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 NCT04847297, which also lists 34 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 19 Apr 2021.