National Survey and Case-vignette Study of Clinical Decisions in Pancreatic Cancer (GECP01)

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.

Study Overview

• Status: Completed
• Conditions: Pancreas Cancer
• Intervention / Treatment: Other: Survey and case vignette

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 Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03016
    • Jose M Ramia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Surgeons responsible of GECP in each center

Description

Inclusion Criteria:

• Resposnible for each center of GECP

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Survey sent in 2020. Time to receive surveys up to 12 weeks

Collaborators and Investigators

• Sponsor: Hospital Miguel Servet
• Collaborators: Hospital General Universitario de Alicante
• Investigators: Principal Investigator: Jose Ramia, PhD, Hospital General Universitario de Alicante

Publications and helpful links

General 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. 2022 Nov 14. doi: 10.1007/s13304-022-01415-1. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: HGUA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No