Pancreas CancerGECP01NCT04755036
National Survey and Case-vignette Study of Clinical Decisions in Pancreatic Cancer
An observational study of Pancreas Cancer, run by Hospital Miguel Servet at 1 site in Spain.
Trial summary
Very few surveys have been carried out about oncosurgical decisions made in patients with pancreatic cancer (PC), and none have established whether the therapeutic approaches differ between low/medium and high volume centers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Survey and case vignette
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgeons responsible of GECP in each center
Who may be able to join
- Resposnible for each center of GECP
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Very few surveys have been carried out about oncosurgical decisions made in patients with pancreatic cancer (PC), and none have established whether the therapeutic approaches differ between low/medium and high volume centers.
A survey was sent out to centers from Spanish Group of Pancreatic Surgery (GECP) asking about usual pre, intra and postoperative management of PC patients and describing five imaginary cases of PC corresponding to common scenarios that surgeons regularly assess in oncosurgical meetings. Investigators define consensus when 80% of answers were equal.
Read the detailed description
In 2019, the Hepato-Pancreato-Biliary Surgery Section of the Spanish Association of Surgeons and the Spanish Chapter of the IHPBA created the Spanish Group of Pancreatic Surgery (henceforth, GECP). The GECP notified the associates of both societies about the creation of the group by email, and also made announcements on their respective web pages. The GECP comprises a council of eight people. On applying to join, hospitals appoint a contact person who receives information on the work of the group, which is carried out on a multicenter basis. Currently, 72 hospitals are part of the GECP. GECP members perform 78% of PDs throughout Spain.
In January 2020, a survey was sent out to the local surgeon manager of each GECP center, describing decisions in pre, intra, and postoperative management of patients with PC undergoing PD and five imaginary cases of patients with PC in the pancreatic head corresponding to five common scenarios that surgeons regularly assess in multidisciplinary oncological meetings (MDTB). It was explained in the cover letter that respondents' answers should not necessarily be the ones that appear in the textbooks or clinical guidelines but should reflect standard clinical practices at their centers. In the interests of objectivity, it was decided that the responses should be anonymous. The questions about decisions and cases were devised by the first author and sent to the seven other members of the GECP organizing committee who evaluated them and finally agreed on their definitive format. The cases presented were: resectable PC without vascular invasion, resectable PC with venous invasion below 180º, borderline PC with venous invasion above 180º, PC with arterial invasion below 180º and severe venous invasion, and PC with liver metastases.
Investigators classified hospital level divided as follows (level 1: 0-250 beds or area <200,000 inhabitants; level 2: 251-500 beds or area <400,000; level 3: > 500 beds or area> 400,000); whether liver transplantation is performed at the center (to assess whether greater experience in vascular reconstruction affected intraoperative vascular management); the number of hospital beds; the number of pancreaticoduodenectomies (PD), distal pancreatectomies (DP) and total pancreatectomies (TP) performed at each center in 2018; and data on the surgeon who completed the survey including age, gender, position and years of experience in pancreatic surgery. Respondents were given a period of 60 days to submit their replies.
The data were collected through an electronic survey using Google Forms and were analyzed with the R statistical software (https://www.r-project.org/). Categorical variables were expressed as number of cases and percentages. For continuous variables, normality was assessed with the Shapiro-Wilk test. Variables that were normal were expressed by means and standard deviation, while those that deviated from normality were expressed with medians and interquartile range. As contrast tests, the chi-square test with Yates correction was used for categorical variables, and the Student's t test and the Mann-Whitney U test for continuous normal and non-normal variables respectively. We defined the existence of a common national criterion when 80% of the respondents applied the same clinical practice.
- Conditions
- Pancreas Cancer
- Being tested
- Survey and case vignette
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey and case vignetteOther
We sent a survey and case vignette cases to every responsible in each center
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of consensus in therapeutical decisions in pancreatic cancer between low/mid vs high volume hospitals
Percentage of consensus in therapeutical decisions. Difference (p<0.05) (if exists) between high and low volume centers
Measured: Survey sent in 2020. Time to receive surveys up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Jan 2020
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
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 Pancreas 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
- Other
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario de Alicante
- Responsible party
- Principal investigator, Mario Serradilla, MD, FACS, Hospital Miguel Servet
- Investigators
- Jose Ramia, PhD, Principal investigator, Hospital General Universitario de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755036
- Sponsor's protocol ID
- HGUA01
- Acronym
- GECP01
- Status last verified
- Feb 2021
- First submitted
- 15 Jan 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramia JM, Cugat E, De la Plaza R, Gomez-Bravo MA, Martin E, Munoz-Bellvis L, Padillo FJ, Sabater L, Serradilla-Martin M. Clinical decisions in pancreatic cancer surgery: a national survey and case-vignette study. Updates Surg. 2023 Jan;75(1):115-131. doi: 10.1007/s13304-022-01415-1. Epub 2022 Nov 14.
PubMed 36376560
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Survey and Case-vignette Study of Clinical Decisions in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04755036
- Acronym / sponsor ID
- GECP01 / HGUA01
- Conditions
- Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hospital Miguel ServetUniversity, hospital or other
- Collaborators
- Hospital General Universitario de Alicante
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Feb 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.
Very few surveys have been carried out about oncosurgical decisions made in patients with pancreatic cancer (PC), and none have established whether the therapeutic approaches differ between low/medium and high volume centers.
A survey was sent out to centers from Spanish Group of Pancreatic Surgery (GECP) asking about usual pre, intra and postoperative management of PC patients and describing five imaginary cases of PC corresponding to common scenarios that surgeons regularly assess in oncosurgical meetings. Investigators define consensus when 80% of answers were equal.
Detailed description
In 2019, the Hepato-Pancreato-Biliary Surgery Section of the Spanish Association of Surgeons and the Spanish Chapter of the IHPBA created the Spanish Group of Pancreatic Surgery (henceforth, GECP). The GECP notified the associates of both societies about the creation of the group by email, and also made announcements on their respective web pages. The GECP comprises a council of eight people. On applying to join, hospitals appoint a contact person who receives information on the work of the group, which is carried out on a multicenter basis. Currently, 72 hospitals are part of the GECP. GECP members perform 78% of PDs throughout Spain.
In January 2020, a survey was sent out to the local surgeon manager of each GECP center, describing decisions in pre, intra, and postoperative management of patients with PC undergoing PD and five imaginary cases of patients with PC in the pancreatic head corresponding to five common scenarios that surgeons regularly assess in multidisciplinary oncological meetings (MDTB). It was explained in the cover letter that respondents' answers should not necessarily be the ones that appear in the textbooks or clinical guidelines but should reflect standard clinical practices at their centers. In the interests of objectivity, it was decided that the responses should be anonymous. The questions about decisions and cases were devised by the first author and sent to the seven other members of the GECP organizing committee who evaluated them and finally agreed on their definitive format. The cases presented were: resectable PC without vascular invasion, resectable PC with venous invasion below 180º, borderline PC with venous invasion above 180º, PC with arterial invasion below 180º and severe venous invasion, and PC with liver metastases.
Investigators classified hospital level divided as follows (level 1: 0-250 beds or area <200,000 inhabitants; level 2: 251-500 beds or area <400,000; level 3: > 500 beds or area> 400,000); whether liver transplantation is performed at the center (to assess whether greater experience in vascular reconstruction affected intraoperative vascular management); the number of hospital beds; the number of pancreaticoduodenectomies (PD), distal pancreatectomies (DP) and total pancreatectomies (TP) performed at each center in 2018; and data on the surgeon who completed the survey including age, gender, position and years of experience in pancreatic surgery. Respondents were given a period of 60 days to submit their replies.
The data were collected through an electronic survey using Google Forms and were analyzed with the R statistical software (https://www.r-project.org/). Categorical variables were expressed as number of cases and percentages. For continuous variables, normality was assessed with the Shapiro-Wilk test. Variables that were normal were expressed by means and standard deviation, while those that deviated from normality were expressed with medians and interquartile range. As contrast tests, the chi-square test with Yates correction was used for categorical variables, and the Student's t test and the Mann-Whitney U test for continuous normal and non-normal variables respectively. We defined the existence of a common national criterion when 80% of the respondents applied the same clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgeons responsible of GECP in each center
Key inclusion criteria (1 listed)
- Resposnible for each center of GECP
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 |
|---|---|---|
| Survey and case vignetteWe sent a survey and case vignette cases to every responsible in each center | Other | – |
Primary outcome
Measurement of consensus in therapeutical decisions in pancreatic cancer between low/mid vs high volume hospitals
Time frame: Survey sent in 2020. Time to receive surveys up to 12 weeks
Percentage of consensus in therapeutical decisions. Difference (p<0.05) (if exists) between high and low volume centers
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 15 Feb 2021.
- Derived from this study: PubMed 36376560Ramia JM, Cugat E, De la Plaza R, Gomez-Bravo MA, Martin E, Munoz-Bellvis L, Padillo FJ, Sabater L, Serradilla-Martin M. Clinical decisions in pancreatic cancer surgery: a national survey and case-vignette study. Updates Surg. 2023 Jan;75(1):115-131. doi: 10.1007/s13304-022-01415-1. Epub 2022 Nov 14.
- 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.
Jose Ramia, PhD principal investigator
Hospital General Universitario de Alicante
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, run by Hospital Miguel Servet at 1 site in Spain.
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 15 Feb 2021. 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 Spain. 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?
Measurement of consensus in therapeutical decisions in pancreatic cancer between low/mid vs high volume hospitals (time frame: Survey sent in 2020. Time to receive surveys up to 12 weeks). 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 NCT04755036, 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 15 Feb 2021.