Postoperative ComplicationsNCT04654299
Biliary Externalization After Pancreaticoduodenectomy
An observational study of Postoperative Complications, run by Universidad de Extremadura.
Trial summary
Postoperative pancreatic fistula(POPF) is the most common complication of pancreaticoduodenectomy (PD). Sometimes POPF is associated with biliary fistula(BF), or "mixed" fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- External biliary stent
- Type of treatment
- Surgery or procedure
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Mar 2018
- 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: Patients undergo elective pancreaticoduodenectomy
Who may be able to join
- Provision of informed consent
- Patient age > 18 years old;
- Elective pancreaticoduodenectomy performed for primary pancreatic disease.
Who cannot join
- Pancreaticoduodenectomy with multivisceral resection (organ other than duodenum, pancreas, gallbladder, and bile duct);
- Patients with peritoneal or liver metastases found during surgery.
About this study
Official title: Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy
Postoperative pancreatic fistula(POPF) is the most common complication of pancreaticoduodenectomy (PD). Sometimes POPF is associated with biliary fistula(BF), or "mixed" fistula. The purpose of this study is to assess whether the severity of the fistulae, when present, is decreased with an external biliary stent in place.
Read the detailed description
n this single-center study we analyze patients who underwent elective PD from January_2014 to December_2017. Patients are divided into two groups: standard PD (ST-PD)vs PD with external biliary stent(PD-BS). Demographic, preoperative, intraoperative, and postoperative variables will be analyze, including complications according to the Clavien-Dindo classification, and those specific to pancreatic surgeries, and mortality rates within 90 days of operation.
- Conditions
- Postoperative Complications
- Being tested
- External biliary stent
- Keywords
- Pancreaticoduodenectomy, Pancreatic postoperative fistula
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External biliary stentProcedure or surgery
The biliary stent consisted of a multi-perforated, natural rubber tube, measuring 3.5 mm in diameter, that we placed transanastomotically, with exteriorization sited at 20 cm utilizing the Witzel jejunostomy approach
| Study group | Role | What they receive |
|---|---|---|
| standard PD (ST-PD) | Pancreacoduodenectomy with pancreatic-enteric reconstruction and standard hepaticojejunostomy | |
| PD with external biliary stent(PD-BS) | Pancreacoduodenectomy with pancreatic-enteric reconstruction and hepaticojejunostomy with external biliary stent for externalization of bile fluid Receives: Procedure: External biliary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Any postoperative complications
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jan 2014
- Primary completion31 Dec 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerardo Blanco-Fernández, Universidad de Extremadura
- Investigators
- Gerardo Blanco-Fernández, MD, PhD, Study director, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654299
- Sponsor's protocol ID
- 20201129
- Status last verified
- Jun 2022
- First submitted
- 29 Nov 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blanco-Fernandez G, Jaen-Torrejimeno I, De-Armas-Conde N, Rojas-Holguin A, Naharro JS, Castillo-Tunon JM, Lopez-Guerra D. Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy. J Gastrointest Surg. 2021 Nov;25(11):2881-2888. doi: 10.1007/s11605-021-04983-6. Epub 2021 Mar 25.
PubMed 33768426
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT04654299
- Acronym / sponsor ID
- 20201129
- Conditions
- Postoperative Complications
- Keywords
- Pancreaticoduodenectomy, Pancreatic postoperative fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 4 Dec 2020 (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.
Postoperative pancreatic fistula(POPF) is the most common complication of pancreaticoduodenectomy (PD). Sometimes POPF is associated with biliary fistula(BF), or "mixed" fistula. The purpose of this study is to assess whether the severity of the fistulae, when present, is decreased with an external biliary stent in place.
Detailed description
n this single-center study we analyze patients who underwent elective PD from January_2014 to December_2017. Patients are divided into two groups: standard PD (ST-PD)vs PD with external biliary stent(PD-BS). Demographic, preoperative, intraoperative, and postoperative variables will be analyze, including complications according to the Clavien-Dindo classification, and those specific to pancreatic surgeries, and mortality rates within 90 days of operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard PD (ST-PD) | – | –Pancreacoduodenectomy with pancreatic-enteric reconstruction and standard hepaticojejunostomy |
| PD with external biliary stent(PD-BS) | – | Procedure: External biliary stentPancreacoduodenectomy with pancreatic-enteric reconstruction and hepaticojejunostomy with external biliary stent for externalization of bile fluid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergo elective pancreaticoduodenectomy
Key inclusion criteria (3 listed)
- Provision of informed consent
- Patient age > 18 years old;
- Elective pancreaticoduodenectomy performed for primary pancreatic disease.
Key exclusion criteria (2 listed)
- Pancreaticoduodenectomy with multivisceral resection (organ other than duodenum, pancreas, gallbladder, and bile duct);
- Patients with peritoneal or liver metastases found during surgery.
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 |
|---|---|---|
| External biliary stentThe biliary stent consisted of a multi-perforated, natural rubber tube, measuring 3.5 mm in diameter, that we placed transanastomotically, with exteriorization sited at 20 cm utilizing the Witzel jejunostomy approach | Procedure or surgery | PD with external biliary stent(PD-BS) |
Primary outcome
Postoperative complications
Time frame: 90 days
Any postoperative complications
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 21 Jun 2022.
- Derived from this study: PubMed 33768426Blanco-Fernandez G, Jaen-Torrejimeno I, De-Armas-Conde N, Rojas-Holguin A, Naharro JS, Castillo-Tunon JM, Lopez-Guerra D. Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy. J Gastrointest Surg. 2021 Nov;25(11):2881-2888. doi: 10.1007/s11605-021-04983-6. Epub 2021 Mar 25.
- 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. This study is not recruiting at the moment.
Gerardo Blanco-Fernández, MD, PhD study director
Universidad de Extremadura
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Universidad de Extremadura.
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 3 inclusion and 2 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 21 Jun 2022. 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?
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?
Postoperative complications (time frame: 90 days). 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 NCT04654299, which also lists 1 linked publication.
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 21 Jun 2022.