Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04755036 |
| Other study ID # |
HGUA01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
Hospital Miguel Servet |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
