Evaluation of decentralized artificial intelligence methods in visceral surgery
Organizational Data
- DRKS-ID:
- DRKS00030874
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2022-12-09
- Last update in DRKS:
- 2024-01-05
- Registration type:
- Prospective
Acronym/abbreviation of the study
SURGICAL SWARM
URL of the study
No Entry
Brief summary in lay language
For the use of artificial intelligence (AI) in assistance systems, large amounts of training data are needed to train the systems for their use. In the field of medicine, these data are usually patient data such as age, image data or data on the clinical course. Such data could be used, for example, to train algorithms that identify patients at risk and thus lead to better care. Currently, only a few data sets are publicly available for the development of appropriate AI systems in surgery, and they are also of low diversity. They are also mostly generated in surgical procedures that are not very complex and have few complications. Furthermore, due to data protection regulations, direct exchange of sensitive patient data between centers is difficult. Decentralized AI systems enable collaboration between centers through indirect data transfer: instead of the actual data, only metadata of the AI models trained in a center are exchanged. In order for decentralized systems to make clinically relevant predictions about potential complications and surgical endpoints, these data must be collected from multiple centers. The study aims to investigate how precisely using decentralized AI methods, in particular swarm learning, a prediction of clinically relevant surgical endpoints (including complications) is possible when including multicenter (image) data (including minimally invasive surgery videos).
Brief summary in scientific language
The limited availability and diversity of training data is one of the major challenges in the development of clinically relevant artificial intelligence (AI) applications in medicine. This problem is particularly pronounced in the field of Surgical Data Science1 , where very few open access datasets exist for training and validation of AI models compared to other medical fields such as radiology, histopathology, or dermatology. Existing anonymized open access datasets of intraoperative surgical video data (e.g., the Cholec80 dataset2) are mostly from less complex and low-complication surgical procedures such as cholecystectomy. The amount and diversity of training data required to develop and validate generalizing and thus clinically meaningful AI systems can only be achieved through collaboration between multiple medical institutions, especially for complex and less frequently performed surgeries such as oncology procedures. However, the exchange of patient data between medical institutions is subject to data protection regulations, which in practice results in a variety of legal and logistical hurdles, especially when international cooperation partners are involved. In this project, these challenges will be addressed on a methodological level by applying decentralized machine learning methods. The goal is to predict surgical complications and clinical endpoints after surgical procedures based on categorical and numerical data as well as image data. image data. Methodologically, decentralized learning methods will be used, in particular Swarm Learning. This is a decentralized deep learning method that enables peer-to-peer collaboration between scientific partners without direct data exchange or data centralization. Models trained locally at collaborating institutions (Swarm Nodes), which use exclusively use data from the respective institution, are combined using blockchain-based communication within the Swarm network. Since only metadata is shared within this network, there is no exchange of sensitive patient data and also ensures equal collaboration among participating institutions. Previous studies have demonstrated that Swarm Learning outperforms locally trained models at individual sites in a variety of use cases, such as in the detection and classification of pulmonary nodules from chest radiographs, in the context of predicting spread patterns of COVID-19 or for predicting genetic aberrations in solid tumors based on routine histopathological sections. In the context of this study, it is planned to systematically apply Swarm Learning for the first time to medical (image) data in surgery.
Health condition or problem studied
- Free text:
- minimally invasive appendectomy, minimally invasive oncologic rectal resection with total mesorectal excision
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Patients undergoing minimally invasive appendectomy, minimally invasive oncologic rectum resection with total mesorectal excision or the appropriately defined other minimally invasive surgery.
Endpoints
- Primary outcome:
- The primary objective of this study is to establish and investigate the validity of decentralized AI methods in the context of surgical (image) data analysis for predicting clinically relevant surgical outcome parameters.
- Secondary outcome:
- not applicable
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- Both
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- France
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie Dresden
- University medical center Klinik für Kinderchirurgie Dresden
- Medical center Asklepios-ASB Klinik Radeberg, Klinik für Allgemein- und Viszeralchirurgie Radeberg
- Medical center Städtisches Klinikum Dresden-Friedrichstadt, Klinik für Allgemein- und Viszeralchirurgie Dresden
- Medical center Krankenhaus St- Joseph-Stift Dresden, Klinik für Chirurgie Dresden
- Medical center Diakonissenkrankenhaus Dresden, Klinik für Viszeralchirurgie und Proktologie Dresden
- Medical center Elblandklinikum Meißen, Zentrum für Allgemein- und Viszeralchirurgie Meißen
- Medical center Oberlausitz-Kliniken Krankenhaus Bautzen, Chirurgische Klinik Bautzen
- University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Heidelberg
- Medical center St. Elisabethen-Klinikum Ravensburg, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie Ravensburg
- University medical center Hôpitaux Universitaires de Strasbourg, Hôpital civil – Chirurgie digestive et endocrinienne Straßburg
Recruitment period and number of participants
- Planned study start date:
- 2024-06-01
- Actual study start date:
- No Entry
- Planned study completion date:
- 2028-06-30
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 1000
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Archived video recordings of minimally invasive surgery on the colorectum, upper gastrointestinal tract, hepatopancreatobiliary system, or other minimally invasive surgery on the thorax or abdomen. - Anonymization of video data - Legitimacy of data use in the context of this subproject: Institutional approval of data sharing in anonymized form or public availability of video data (e.g., online or in the context of scientific publications) - Clinical indication for minimally invasive appendectomy (subproject (B)), minimally invasive oncological rectal resection (subproject (C)) with total mesorectal excision, or for the minimally invasive surgery defined accordingly (subproject (D)).
Exclusion Criteria
Conversion of surgery to open surgical technique prior to appendix deposition (subproject (B)) or prior to total mesorectal excision (subproject (C)).
Addresses
Primary Sponsor
- Address:
- Technische Universität Dresden01062 DresdenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Carl Gustav CarusDr. Fiona KolbingerFetscherstr. 7401307 DresdenGermany
- Telephone:
- +493514584098
- Fax:
- +483514587273
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum Carl Gustav CarusProf. Dr. Marius DistlerFetscherstr. 7401307 DresdenGermany
- Telephone:
- +493514584098
- Fax:
- +483514587273
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum Carl Gustav CarusProf. Dr. Marius DistlerFetscherstr. 7401307 DresdenGermany
- Telephone:
- +493514584098
- Fax:
- +483514587273
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Carl Gustav Carus01307 DresdenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission an der TU DresdenFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49-351-4582992
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-07-20
- Ethics committee number:
- BO-EK-332072022
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-08-04
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- Maier-Hein L, Vedula SS, Speidel S, et al. Surgical data science for next-generation interventions. Nat. Biomed. Eng. 2017. DOI:10.1038/s41551-017-0132-7
- Twinanda AP, Shehata S, Mutter D, Marescaux J, de Mathelin M, Padoy N. EndoNet: A Deep Architecture for Recognition Tasks on Laparoscopic Videos. IEEE Trans Med Imaging 2016; 36: 86–97
- Maier-Hein L, Eisenmann M, Sarikaya D, et al. Surgical data science – from concepts toward clinical translation. Med Image Anal 2022; 76: 102306
- Warnat-Herresthal S, Schultze H, Shastry KL, et al. Swarm Learning for decentralized and confidential clinical machine learning. Nature 2021; 594: 265–70
- Saldanha OL, Quirke P, West NP, et al. Swarm learning for decentralized artificial intelligence in cancer histopathology. Nat Med 2022 2022; : 1–8
- A healthy lifestyle - WHO recommendations. https://www.who.int/europe/news- room/fact-sheets/item/a-healthy-lifestyle---who-recommendations
- Andersson REB. Meta-analysis of the clinical and laboratory diagnosis of appendicitis. Br J Surg 2003; 91: 28–37
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry