Gastrointestinal Complications after Elective Pancreatoduodenectomy Do Not Differ between Perioperative Epidural Analgesia and Patient-Controlled Intravenous Analgesia: The Randomised Controlled PAKMAN Trial

Klotz, Rosa; Larmann, Jan; Klose, Christina; Brückner, Thomas; Benner, Laura; Doerr-Harim, Colette; Tenckhoff, Solveig; Lock, Johan Friso; Brede, Elmar-Marc; Salvia, Roberto; Polati, Enrico; Köninger, Jörg; Schiff, Jan-Henrik; Wittel, Uwe A.; Hötzel, Alexander; Keck, Tobias; Nau, Carla; Amati, Anca-Laura; Koch, Christian; Eberl, Thomas; Zink, Michael; Tomažič, Aleš; Novak-Jankovič, Vesna; Hofer, Stefan; Weigand, Markus A.; Büchler, Markus W.; Knebel, Phillip

doi:10.2139/ssrn.3475584

Cited by 1 publication

(1 citation statement)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Considering that approximately 5 patients will be excluded due to inoperability or the implementation of another type of pancreatectomy, an overall number of 35 patients will be allocated to the trial (figure 2). From previous randomised controlled trials on distal pancreatectomy and partial pancreatectomy and from a review of the literature, there is good evidence that the rate of POPF after distal pancreatectomy is 40%6 13 and 20% after partial pancreatoduodenectomy 5 32. Accordingly, we expect about 10 patients to develop a POPF and SmartPAN-driven closure attempts by the operating surgeon will be described and compared with literature controls as basis for subsequent interventional trials.…”

Section: Methods and Analysismentioning

confidence: 99%

Intraoperative visualisation of pancreatic leakage (ViP): study protocol for an IDEAL Stage I Post Market Clinical Study

et al. 2022

Self Cite

View full text Add to dashboard Cite

IntroductionPancreatic resections are an important field of surgery worldwide to treat a variety of benign and malignant diseases. Postoperative pancreatic fistula (POPF) remains a frequent and critical complication after partial pancreatectomy and affects up to 50% of patients. POPF increases mortality, prolongs the postoperative hospital stay and is associated with a significant economic burden. Despite various scientific approaches and clinical strategies, it has not yet been possible to develop an effective preventive tool. The SmartPAN indicator is the first surgery-ready medical device for direct visualisation of pancreatic leakage already during the operation. Applied to the surface of pancreatic tissue, it detects sites of biochemical leak via colour reaction, thereby guiding effective closure and potentially mitigating POPF development.Methods and analysisThe ViP trial is a prospective single-arm, single-centre first in human study to collect data on usability and confirm safety of SmartPAN. A total of 35 patients with planned partial pancreatectomy will be included in the trial with a follow-up of 30 days after the index surgery. Usability endpoints such as adherence to protocol and evaluation by the operating surgeon as well as safety parameters including major intraoperative and postoperative complications, especially POPF development, will be analysed.Ethics and disseminationFollowing the IDEAL-D (Idea, Development, Exploration, Assessment, and Long term study of Device development and surgical innovation) framework of medical device development preclinical in vitro, porcine in vivo, and human ex vivo studies have proven feasibility, efficacy and safety of SmartPAN. After market approval, the ViP trial is the IDEAL Stage I trial to investigate SmartPAN in a clinical setting. The study has been approved by the local ethics committee as the device is used exclusively within its intended purpose. Results will be published in a peer-reviewed journal. The study will provide a basis for a future randomised controlled interventional trial to confirm clinical efficacy of SmartPAN.Trial registration numberGerman Clinical Trial Register DRKS00027559, registered on 4 March 2022.

show abstract

Section: Methods and Analysismentioning

confidence: 99%