Prospective Snapshot Audit of Distal Pancreatectomy in Spain

NCT ID: NCT04900012

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-10-31

Brief Summary

Distal pancreatectomy is the surgical technique performed to treat many pancreatic diseases located in neck and tail of the pancreas. Laparoscopic approach is the gold standard but in many centres the percentage of laparoscopic approach is still low. This technique has low mortality but 30% morbidity mostly related to pancreatic fistula. Some new devices (linear stapler, energy devices and patches) seem to decrease pancreatic fistula but there is not evidence based medicine that confirm the results published usually in unicentric studies.

Detailed Description

Snapshot observational study including most of the Spanish pancreatic units that perform distal pancreatectomy. One year consecutive cases.

Main objectives.

1. percentage of laparoscopic approach in Spain

2. Morbidity at 90 days measured by CCI and Clavien Dindo

3. Percentage of pancreatic fistula

4. Impact of new device to decrease pancreatic fistula

Conditions

Surgery--Complications; Pancreas Disease; Pancreatic Fistula

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Distal pancreatectomy

All cases operated on performing distal pancreatectomy in involved Units

Distal pancreatectomy

Intervention Type: PROCEDURE

We are going to collect all cases

Interventions

Distal pancreatectomy

We are going to collect all cases

Intervention Type: PROCEDURE

Other Intervention Names

corporocaudal pancreatectomy

Eligibility Criteria

Inclusion Criteria

-All distal pancreatectomies performed in involved Units

Exclusion Criteria

• No sign of informed consent for entering in the study
• Emergency procedures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General Universitario de Alicante

OTHER

Sponsor Role: lead

Responsible Party

Candido Fernando Alcazar-Lopez

MD PHD Senior consultant HPB surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2021/078

Identifier Type: -

Identifier Source: org_study_id