Minimally invasive versus open pancreatoduodenectomy

Completed

• Conditions: peri-ampullaire aandoeningen/tumoren/cysten; cancer; tumor; 10017990; 10017998

• Registration Number: NL-OMON44749
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 136

Inclusion Criteria

• Age equal or above 18 years
• Indication for elective pancreatoduodenectomy because of a malignant, pre-malignant or symptomatic benign disease located in the pancreatic head, distal bile duct, duodenum or ampulla of Vater
• The procedure can be performed both laparoscopically and open according to the local surgeon
• Fit to undergo pancreatoduodenectomy according to the surgeon and anaesthetist

Exclusion Criteria

• A second cancer requiring resection during the same procedure
• Administration of neo-adjuvant radiotherapy
• Vascular involvement (portal vein, superior mesenteric vein, superior mesenteric artery or hepatic artery)
• Pregnancy
• Body mass index >35 kg/m2
• Participation in another study with interference of study outcomes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase 2:<br /><br>- IL-6 serum levels<br /><br><br /><br>Phase 3:<br /><br>- Time to functional recovery, defined as: independently mobile (or as mobile<br /><br>as preoperatively), adequate pain control with only oral analgesia, the ability<br /><br>to maintain at least 50% of daily required caloric intake, no intravenous fluid<br /><br>administration, no signs of active infection.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Clavien-Dindo III or higher complications<br /><br>- Individual complications<br /><br>- Mortality<br /><br>- Quality of life<br /><br>- Costs<br /><br>- Other operative outcomes<br /><br>- Other postoperative outcomes</p><br>