Minimally invasive versus open pancreato-duodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): an international multicenter patient-blinded randomized controlled trial

Phase 3

Recruiting

• Conditions: (pre)maligne pancreas- en/of periampullaire tumoren; Pancreatic- and/or periampullary neoplasm/tumors; 10017990; 10017998

• Registration Number: NL-OMON54170
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 290

Inclusion Criteria

• Age at least 18 years;
• Indication for elective pancreatoduodenectomy for a tumor located in the
pancreatic head, distal bile duct, duodenum or ampulla of Vater; in the second
phase of the study (after 288 patients are included) only patients with a
malignant tumor of the pancreatic head or distal bile duct will be eligible for
inclusion
• Both minimally invasive pancreatoduodenectomy and open pancreatoduodenectomy
are technically feasible for radical resection, according to the local
treatment team;
• Pre-operative multiphase CT scan showing no signs of vascular involvement (3D
reconstruction optional).
o In case of (suspected) malignancy: maximum 28 days old CT-scan available.
• Fit to undergo pancreatoduodenectomy according to the surgeon and
anesthesiologist
• Written informed consent

Exclusion Criteria

- A second cancer requiring resection during the same procedure - Chronic
pancreatitis as indication (including Groove pancreatitis) - Any vascular
involvement (portal vein, superior mesenteric vein, superior mesenteric artery,
coeliac artery or hepatic artery) - Pregnancy - Body mass index >35 kg/m2 -
Participation in another study with interference of study outcomes - Not able
or willing to complete the (quality-of-life) questionnaires Hybrid procedures
in which the resection is performed via a laparoscopic approach and the
reconstruction via an open approach are not allowed in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified