Partial removal of the pancreas – a study comparing minimally invasive surgery with open surgery (DISPACT-2)
Résumé de l'étude
The success of a surgery depends not only on the disease but also on the damage from the surgical access. Minimally invasive surgery reduces postoperative pain and leads to improved mobility, fewer pulmonary infections, and faster recovery and better quality of life. The DISPACT 2 study examines differences between open and minimally invasive distal pancreatic resection regarding postoperative complications, further clinical and oncological efficacy, safety, quality of life, and costs. Additionally, patient-relevant outcomes and oncological safety are investigated. In the case of an equal number of postoperative complications and given oncological safety, and with improved quality of life, minimally invasive resection should be offered to patients as the first choice.
(BASEC)
Intervention étudiée
Minimally invasive procedures, namely laparoscopic (classic keyhole technique) and robot-assisted procedures, are compared with classic open surgeries on the pancreas.
The main difference between the procedures lies in the access to the organ in the patient's body. In the first group, the minimally invasive group, small incisions are used and work is done under indirect vision after inserting a camera through the abdominal wall. In the open procedure, the surgeon makes a long transverse or longitudinal incision in the abdominal wall and can directly see and operate on the abdominal organs.
(BASEC)
Maladie en cours d'investigation
The group of patients has in common that surgery on the pancreas is necessary. There is no uniform underlying disease. Both patients with benign and malignant diseases will be included.
(BASEC)
Patient age of at least 18 years Planned removal of the tail of the pancreas with or without spleen removal Ability to understand the nature and individual consequences of the clinical study Written consent of the participants (BASEC)
Critères d'exclusion
In the case of malignant tumors, if there is spread to other organs or large vessels of the abdominal organs or the organs themselves are infiltrated High tumor marker levels in the blood Relevant comorbidities that significantly increase the mortality of such surgery Previous major open abdominal surgery Participation in another study that could interfere with the intervention and the results of this (BASEC)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Informations générales
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
06221-5636337
beat.mueller@clutterclarunis.ch(ICTRP)
Informations scientifiques
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
06221-566986
beat.mueller@clutterclarunis.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
12.07.2023
(BASEC)
Identifiant de l'essai ICTRP
DRKS00014011 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
non disponible
Titre académique
Distal Pancreatectomy – A randomised controlled trial to compare minimal-invasive distal pancreatectomy to open resection (DISPACT-2 Trial) - DISPACT 2 (ICTRP)
Titre public
Distal Pancreatectomy – A randomised controlled trial to compare minimal-invasive distal pancreatectomy to open resection (DISPACT-2 Trial) (ICTRP)
Maladie en cours d'investigation
;C25.1 - Malignant neoplasm: Body of pancreas;C25.2 - Malignant neoplasm: Tail of pancreas;C25.3 - Malignant neoplasm: Pancreatic duct;C25.4 - Malignant neoplasm: Endocrine pancreas;C25.7 - Malignant neoplasm: Other parts of pancreas;K86.0 - Alcohol-induced chronic pancreatitis;K86.1 - Other chronic pancreatitis;D13.6 - Benign neoplasm: Pancreas (ICTRP)
Intervention étudiée
Intervention 1: Minimal-invasive distal pancreatectomy (MIDP) Intervention 2: Open distal pancreatectomy (ODP) (ICTRP)
Type d'essai
interventional (ICTRP)
Plan de l'étude
Allocation: Randomized controlled trial;. Masking: Blinded (assessor). Control: Active control (effective treament of control group). Assignment: Parallel. Study design purpose: Treatment; (ICTRP)
Critères d'inclusion/exclusion
Inclusion criteria: - Planned distal pancreatectomy with or without splenectomy for any indication
- Age = 18 years
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (ICTRP)
Exclusion criteria: - Patients scheduled for a pancreatic resection other than distal pancreatectomy
- Distant organ metastases or tumour infiltration of the superior mesenteric vein, superior mesenteric artery or hepatic artery
- Infiltration of adjacent organs
- CA 19-9 >1000 IU/ml
- ASA >3
- Prior major open abdominal surgery
- Participation in another intervention-trial with interference of intervention and outcome of this study
- Lack of compliance and lack of written informed consent
Critères d'évaluation principaux et secondaires
Postoperative mortality and morbidity assessed as comprehensive complication index (CCI) 3 months after intervention. (ICTRP)
- Operation time
- Intraoperative blood loss
- Conversion rate (minimal-invasive group)
- Days on ICU
- Pain (NRS)
- Mobility
- Length of hospital stay
- Time to functional recovery
- Pancreas-associated morbidity (pancreatic fistula, delayed gastric emptying, postoperative hemorrhage)
- Surgical site infection
- Re-intervention rate
- Time to return to work
- Quality of Life (EORTC QLQ-C30 and PAN 28 (CP))
- Incisional hernia rate
- Survival rate after 12 and 24 months
- R0 / R1 resection rates
- Lymph node count in oncological group
- DRG case cost (ICTRP)
Date d'enregistrement
20.03.2018 (ICTRP)
Inclusion du premier participant
13.08.2020 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
Pascal Probst, pascal.probst@med.uni-heidelberg.de, 06221-5636337, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie (ICTRP)
ID secondaires
U1111-1209-1592, S-693/2017 (ICTRP)
Résultats-Données individuelles des participants
YesAfter publication the data set will be available upon request for further research also to non-participating parties. (ICTRP)
Informations complémentaires sur l'essai
http://www.drks.de/DRKS00014011 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible