Applying an intraoperative predictive indicator for postoperative pancreatic fistula: randomized preclinical trial

Pausch, Thomas; Mitzscherling, Clara; Aubert, Ophelia; Liu, X; Gesslein, Bodil; Brückner, Thomas; Kommoss, Felix K.F.; Golriz, Mohammad; Mehrabi, Arianeb; Hackert, Thilo

doi:10.1093/bjs/znaa115

Cited by 4 publications

(16 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Next, we tested the pathological consequences of in situ SmartPAN application during pancreatic resection. There were no significant differences in macroscopic or microscopic pathological indicators between pigs treated with SmartPAN or saline, although there were clear signs of pathology due to untreated pancreatic leaks 18 . Similarly, there were no significant differences between groups in the amylase levels of drainage fluid.…”

Section: Discussionmentioning

confidence: 78%

“…The amylase content of drainage fluid was monitored over 7 days of post‐operative follow‐up by retrieving samples in the morning and analysing them at Heidelberg University Hospital's central laboratory 17,18 . Drainage amylase was compared between pigs treated with SmartPAN or saline using Mann–Whitney tests for each day.…”

Section: Methodsmentioning

confidence: 99%

“…The amylase content of drainage fluid was monitored over 7 days of post-operative follow-up by retrieving samples in the morning and analysing them at Heidelberg University Hospital's central laboratory. 17,18 Drainage amylase was compared between pigs treated with SmartPAN or saline using Mann-Whitney tests for each day. Next, biochemical leaks (the initial clinical stage of POPF) were diagnosed according to the criteria of the International Study Group of Pancreatic Fistula, ISGPF.…”

Section: In Vivo Assessment Of Abdominal Damage Following Surgical Sm...mentioning

confidence: 99%

“…Previous studies describe the development of the biomaterial and its efficacy at mitigating POPF-related symptoms in a porcine (Sus scrofa domesticus) model. 17,18 Specifically, SmartPAN can demonstrably detect pancreatic leakage in the immediate area of damaged ducts with high sensitivity and specificity and successfully guide targeted closure to reduce the incidence of POPF-related symptoms.…”

Section: Introductionmentioning

confidence: 99%

“…SmartPAN provides practitioners with an inexpensive tool that can be used during surgery without specialized training or equipment and which can be easily removed by lavage (Figure 1A). Previous studies describe the development of the biomaterial and its efficacy at mitigating POPF‐related symptoms in a porcine ( Sus scrofa domesticus ) model 17,18 . Specifically, SmartPAN can demonstrably detect pancreatic leakage in the immediate area of damaged ducts with high sensitivity and specificity and successfully guide targeted closure to reduce the incidence of POPF‐related symptoms.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

SmartPAN: In vitro and in vivo proof‐of‐safety assessments for an intra‐operative predictive indicator of postoperative pancreatic fistula

Pausch

Bartel

Cui

et al. 2022

Basic Clin Pharma Tox

Self Cite

View full text Add to dashboard Cite

Pancreatic surgery is complicated by untreated fluid leakage, but no tenable techniques exist to detect and close leakage sites during surgery. A novel hydrogel called SmartPAN has been developed to meet this need and is here assessed for safety before trials on human patients. First, resazurin assays were used to test the cytotoxic effects of SmartPAN's active bromothymol blue (BTB) indicator and its solution of phosphate‐buffered saline (PBS) on normal (HPDE: human pancreatic duct epithelial) or carcinomic (FAMPAC) human pancreatic cells. Cells incubated with BTB showed no significant reduction in cell viability below threshold safety levels. However, PBS had a mild cytotoxic effect on FAMPAC cells. Second, SmartPAN's pathological effects were evaluated in vivo by applying 4‐ml SmartPAN to a porcine (Sus scrofa domesticus) model of pancreatic resection. There were no significant differences in macroscopic and microscopic pathologies between pigs treated with SmartPAN or saline. Third, measurements using HPLC‐MS/MS demonstrate that BTB does not cross into the bloodstream and was eliminated from the body within 2 days of surgery. Overall, SmartPAN appears safe in the short term and ready for first‐in‐human trials because its components are either biocompatible or quickly neutralized by dilution and drainage.

show abstract

Section: Discussionmentioning

confidence: 78%

Section: Methodsmentioning

confidence: 99%

Section: In Vivo Assessment Of Abdominal Damage Following Surgical Sm...mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

SmartPAN: In vitro and in vivo proof‐of‐safety assessments for an intra‐operative predictive indicator of postoperative pancreatic fistula

Pausch

Bartel

Cui

et al. 2022

Basic Clin Pharma Tox

Self Cite

View full text Add to dashboard Cite

show abstract

This month on Twitter

Kelly¹

2021

British Journal of Surgery

View full text Add to dashboard Cite

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

Applying an intraoperative predictive indicator for postoperative pancreatic fistula: randomized preclinical trial

Cited by 4 publications

References 19 publications

SmartPAN: In vitro and in vivo proof‐of‐safety assessments for an intra‐operative predictive indicator of postoperative pancreatic fistula

SmartPAN: In vitro and in vivo proof‐of‐safety assessments for an intra‐operative predictive indicator of postoperative pancreatic fistula

This month on Twitter

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

Contact Info

Product

Resources

About