Pancreatic- and/or periampullary neoplasm/tumors pancreatic cancer
Conditions
Interventions
Minimally invasive (laparoscopic or robot-assisted) pancreatoduodenectomy
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is CCI® (Comprehensive Complication Index), measuring all complications up to 90 days after surgery, all scored according to the Clavien-Dindo classification: Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutritionare also included. Grade III: Requiring surgical, endoscopic or radiological intervention - IIIa Intervention not under general anesthesia - IIIb Intervention under general anesthesia Grade IV: Life-threatening complication (including CNS complications)* requiring IC/ICU-management - IVa single organ dysfunction (including dialysis) - IVb multiorgandysfunction Grade V Death of a patient. The CCI score is a cumulative representation of all post-operative complications, in a score from 0 (no complications) to 100 (worst outcome = death of patient). For the second study phase (DIPLOMA-2x2) the primary endpoint is the microscopically radical resection margin (R0, distance tumor to pancreatic transection and posterior margin >= 1 mm), which is assessed using a Royal College of Pathologists criteria. This histopathological assessment includes both the transection and posterior margins (surgical margins), but excludes theand the anterior and superior/inferior margins/surface (anatomical margins). In order to ensure uniformity, study coordinators will be present in all centers during surgery of the first patient and subsequent handling of the specimen by the pathologist. Pathologists will be asked to report the individual margins/surfaces. A secondary analysis w | — |
Secondary
| Measure | Time frame |
|---|---|
| The most relevant secondary endpoint is the time to functional recovery in days. Other secondary endpoints are: - Operative parameters (operative time, blood loss, blood transfusion, conversion) - Postoperative parameters (complications, mortality, re-interventions, activity (measured by activity tracker) - Other pathology parameters (tumor size, lymph node resection, number of positive glands, invasion, grading and staging) - Hospitalization parameters (total length of hospital stay, readmission, intensive care admission) - Oncologic parameters (use of (neo-)adjuvant chemotherapy, 3-year survival, disease-free survival) - Quality of life - Cost of care | — |
Countries
Belgium, Germany, Italy, Netherlands, Sweden, United States
Contacts
Public ContactJE Menso
Amsterdam UMC
Outcome results
None listed