Prospective Snapshot Audit of Distal Pancreatectomy in Spain

Surgery--Complications Clinical Trial

— Spadispan  

Official title:

SPAnish DIStal PANcreatectomy Snapshot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04900012
• Other study ID #: 2021/078
• Status: Not yet recruiting
• Start date: July 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: May 2021
• Source: Hospital General Universitario de Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

-All distal pancreatectomies performed in involved Units

Exclusion Criteria:

• No sign of informed consent for entering in the study

• Emergency procedures

Related Conditions & MeSH terms

• Fistula
• Pancreas Disease
• Pancreatic Diseases
• Pancreatic Fistula
• Surgery--Complications

Intervention

Procedure:
• Distal pancreatectomy
We are going to collect all cases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario de Alicante

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity at 90 days	Morbidity measured with CCI and Clavien at 90 days	90 days
Primary	Laparoscopic approach	Laparoscopic or laparotomy approach	1 year
Secondary	Pancreatic fistula	Percentage of pancreatic fistula	90 days