Anastomosis; ComplicationsGASTROPANNCT04724174
Pancreaticogastrostomy for High-Risk Pancreas
An observational study of Anastomosis; Complications and Pancreatic Fistula, run by Institut Paoli-Calmettes.
Trial summary
In 2013, a double purse-string telescoped pancreaticogastrostomy (PG) technique appeared to significantly reduce the risk of postoperative pancreatic fistula (POPF). This study compared the incidence of clinically relevant POPF in patients with high-risk anastomosis after undergoing PG or pancreaticojejunostomy (PJ)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomosis; Complications, Pancreatic Fistula
- What is being tested?
- pancreaticogastrostomy and pancreaticojejunostomy
- Type of treatment
- Surgery or procedure
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 31 Jan 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient with pancreatic tumor who underwent pancreatoduodenectomy
Who may be able to join
- Pancreatoduodenectomy
- High updated alternative -Fistula Risk Score which was defined > 20%, as the higher-risk category of the alternative-Fistula Risk Score
Who cannot join
- Explorative laparotomy
- Hard pancreatic parenchyma
About this study
Official title: Double Purse-String Telescoped Pancreaticogastrostomy for High Risk Anastomosis: A 6-Year Single Center Case-Controlled Study
In 2013, a double purse-string telescoped pancreaticogastrostomy (PG) technique appeared to significantly reduce the risk of postoperative pancreatic fistula (POPF). This study compared the incidence of clinically relevant POPF in patients with high-risk anastomosis after undergoing PG or pancreaticojejunostomy (PJ) techniques.
Read the detailed description
From 2013 to 2019, consecutive patients with high-risk anastomosis (i.e., updated alternative-Fistula Risk Score (ua-FRS) >20%) underwent pancreatoduodenectomy with either the PJ or PG technique. Optimal mitigation strategy (external stenting and octreotide omission) was applied for all patients. The primary endpoint of the study was the incidence of clinically relevant POPF. Data were entered prospectively into an institutional clinical database (NCT02871336).
- Conditions
- Anastomosis; Complications, Pancreatic Fistula
- Being tested
- pancreaticogastrostomy, pancreaticojejunostomy
- Keywords
- High Risk Pancreatic Anastomosis, Clinically Relevant Pancreatic Fistula, Pancreaticogastrostomy
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreaticogastrostomyProcedure or surgery
Pancreaticogastrostomy technique was performed according to the precise description of Addeo et al.
pancreaticojejunostomyProcedure or surgery
Pancreaticojejunostomy technique was performed using the 5/0 polypropylene interrupted monofilament suture in a one-layered duct-to-mucosa end-to-side anastomosis (Cattell-Warren anastomosis).
| Study group | Role | What they receive |
|---|---|---|
| Pancreaticogastrostomy (PG) group | Patients underwent pancreatoduodenectomy with the PG technique Receives: Procedure: pancreaticogastrostomy | |
| Pancreaticojejunostomy (PJ) group | Patients underwent pancreatoduodenectomy with the PJ technique Receives: Procedure: pancreaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically relevant post operative pancreatic fistula
clinically relevant post operative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery (ISGPS) definition
Measured: at hospital discharge assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Jun 2013
- Primary completion1 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomosis; ComplicationsStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Turrini, PD, Principal investigator, Institut Paoli-Calmettes- (IPC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724174
- Sponsor's protocol ID
- GASTROPAN IPC-2020-029
- Acronym
- GASTROPAN
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Purse-String Telescoped Pancreaticogastrostomy for High Risk Anastomosis: A 6-Year Single Center Case-Controlled Study
- ClinicalTrials.gov ID
- NCT04724174
- Acronym / sponsor ID
- GASTROPAN / GASTROPAN IPC-2020-029
- Conditions
- Anastomosis; Complications, Pancreatic Fistula
- Keywords
- High Risk Pancreatic Anastomosis, Clinically Relevant Pancreatic Fistula, Pancreaticogastrostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 26 Jan 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.
In 2013, a double purse-string telescoped pancreaticogastrostomy (PG) technique appeared to significantly reduce the risk of postoperative pancreatic fistula (POPF). This study compared the incidence of clinically relevant POPF in patients with high-risk anastomosis after undergoing PG or pancreaticojejunostomy (PJ) techniques.
Detailed description
From 2013 to 2019, consecutive patients with high-risk anastomosis (i.e., updated alternative-Fistula Risk Score (ua-FRS) >20%) underwent pancreatoduodenectomy with either the PJ or PG technique. Optimal mitigation strategy (external stenting and octreotide omission) was applied for all patients. The primary endpoint of the study was the incidence of clinically relevant POPF. Data were entered prospectively into an institutional clinical database (NCT02871336).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreaticogastrostomy (PG) group | – | Procedure: pancreaticogastrostomyPatients underwent pancreatoduodenectomy with the PG technique |
| Pancreaticojejunostomy (PJ) group | – | Procedure: pancreaticojejunostomyPatients underwent pancreatoduodenectomy with the PJ technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with pancreatic tumor who underwent pancreatoduodenectomy
Key inclusion criteria (2 listed)
- Pancreatoduodenectomy
- High updated alternative -Fistula Risk Score which was defined > 20%, as the higher-risk category of the alternative-Fistula Risk Score
Key exclusion criteria (2 listed)
- Explorative laparotomy
- Hard pancreatic parenchyma
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 |
|---|---|---|
| pancreaticogastrostomyPancreaticogastrostomy technique was performed according to the precise description of Addeo et al. | Procedure or surgery | Pancreaticogastrostomy (PG) group |
| pancreaticojejunostomyPancreaticojejunostomy technique was performed using the 5/0 polypropylene interrupted monofilament suture in a one-layered duct-to-mucosa end-to-side anastomosis (Cattell-Warren anastomosis). | Procedure or surgery | Pancreaticojejunostomy (PJ) group |
Primary outcome
Incidence of clinically relevant post operative pancreatic fistula
Time frame: at hospital discharge assessed up to 30 days
clinically relevant post operative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery (ISGPS) definition
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 26 Jan 2021.
- 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.
Olivier Turrini, PD principal investigator
Institut Paoli-Calmettes- (IPC)
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomosis; Complications and Pancreatic Fistula, run by Institut Paoli-Calmettes.
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 2 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 26 Jan 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?
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?
Incidence of clinically relevant post operative pancreatic fistula (time frame: at hospital discharge assessed up to 30 days). 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 26 Jan 2021.