Prospective Snapshot Audit of Distal Pancreatectomy in Spain (Spadispan)

SPAnish DIStal PANcreatectomy Snapshot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery--Complications; Pancreatic Fistula; Pancreas Disease
• Intervention / Treatment: Procedure: Distal pancreatectomy

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

• Study Type: Observational
• Enrollment (Anticipated): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

-All distal pancreatectomies performed in involved Units

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Distal pancreatectomy; All cases operated on performing distal pancreatectomy in involved Units	Procedure: Distal pancreatectomy; We are going to collect all cases; Other Names: corporocaudal pancreatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity at 90 days	Morbidity measured with CCI and Clavien at 90 days	90 days
Laparoscopic approach	Laparoscopic or laparotomy approach	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pancreatic fistula	Percentage of pancreatic fistula	90 days

Collaborators and Investigators

• Sponsor: Hospital General Universitario de Alicante

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Digestive System Fistula; Fistula; Pancreatic Fistula; Pancreatic Diseases
• Other Study ID Numbers: 2021/078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: CRD is done. It should be sent to local investigators and fulfilled in a Castor formulary.

Drug and device information, study documents

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