Prospective Snapshot Audit of Distal Pancreatectomy in Spain

NCT04900012 | Unknown

• 1 other identifier: 2021/078
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgery--Complications; Pancreas Disease; Pancreatic Fistula

Outcome Measures

Primary Outcomes (2)

• Morbidity at 90 days

  Morbidity measured with CCI and Clavien at 90 days

  90 days

• Laparoscopic approach

  Laparoscopic or laparotomy approach

  1 year

Secondary Outcomes (1)

• Pancreatic fistula

  90 days

Study Arms (1)

Distal pancreatectomy

All cases operated on performing distal pancreatectomy in involved Units

Procedure: Distal pancreatectomy

Interventions

Distal pancreatectomy PROCEDURE

We are going to collect all cases

Also known as: corporocaudal pancreatectomy

Distal pancreatectomy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All scheduled distal pancreatectomies performed in on year in each Unit.

You may qualify if:

• All distal pancreatectomies performed in involved Units

You may not qualify if:

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

Sponsors & Collaborators

• Hospital General Universitario de Alicante: lead

MeSH Terms

Conditions

Pancreatic Diseases; Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PHD Senior consultant HPB surgeon

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 25, 2021
• Study Start: July 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: October 31, 2022
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share