PANDA trial: PAncreatic Neoplasms and Drainage After surgery

Recruiting

• Conditions: pancreas cancer; pancreascarcinoma; 10015674

• Registration Number: NL-OMON39246
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 360

Inclusion Criteria

- Diagnosis of pancreas head tumour
- Elective Pancreaticoduodenectomy
- Age > 18 years
- ASA I / II / III
- Written informed consent

Exclusion Criteria

- Emergency surgery
- ASA IV / V
- Impossibility to obtain informed consent
- Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Endpoints: The primary outcome of interest is the number of (re-)interventions,<br /><br>specifically for pancreaticojenunostomy-, gastrojejunostomy- or<br /><br>hepaticojejunostomy anastomosis leakage, abscess, intra-abdominal fluid<br /><br>collections and postoperative haemorrhage, which are defined as drain related<br /><br>complications. Re-interventions are defined as the administration of<br /><br>antibiotics, endovascular coiling or stenting, ultrasound or CT guided drainage<br /><br>or relaparotomy. Furthermore all complications will be monitored.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes of interest are functional recovery and delay in<br /><br>discharge, readmissions, mortality and total length of hospital stay.</p><br>