Gastroparesis Clinical Trial
Official title:
Respiratory and Hemodynamic Implications of Endoscopic Myotomy of the Esophagus and Stomach (POEM/GPOEM)
The goal of this observational study is to learn about hemodynamic and respiratory repercussions during general anesthesia in patients with achalasia or gastroparesis who underwent an endoscopic treatment such as a peroral endoscopic myotomy (POEM) or gastric (GPOEM). The main questions it aims to answer are: - Are there predictable elements reliable to this study-population for the occurrence of adverse events/complications? - Is there a correlation between the value (percutaneous puncture) of the intra-abdominal pressure and the variations of the patient's respiratory and hemodynamic parameters in the event of a pneumoperitoneum complication? Participants will be treated with the usual standard of care for this procedure and no additional or specific therapy will be planned for this study.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | November 1, 2025 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Completed and signed consent form (consent form attached) - Age = 18 years old - Anesthetic risk classification according to ASA, from 1 to 3 - Patients summoned for POEM or GPOEM type endoscopy treatment Exclusion Criteria: - Inability to follow study procedures, eg. due to language problems, psychological disorders, dementia, etc. of the participant |
Country | Name | City | State |
---|---|---|---|
Switzerland | CHUV | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Vaudois |
Switzerland,
Bang YS, Park C. Anesthetic Consideration for Peroral Endoscopic Myotomy. Clin Endosc. 2019 Nov;52(6):549-555. doi: 10.5946/ce.2019.033. Epub 2019 Jul 10. — View Citation
Darisetty S, Nabi Z, Ramchandani M, Chavan R, Kotla R, Nageshwar Reddy D. Anesthesia in per-oral endoscopic myotomy: A large tertiary care centre experience. Indian J Gastroenterol. 2017 Jul;36(4):305-312. doi: 10.1007/s12664-017-0782-0. Epub 2017 Aug 24. — View Citation
Jayan N, Jacob JS, Mathew M, Mukkada RJ. Anesthesia for peroral endoscopic myotomy: A retrospective case series. J Anaesthesiol Clin Pharmacol. 2016 Jul-Sep;32(3):379-81. doi: 10.4103/0970-9185.188829. — View Citation
Loser B, Werner YB, Punke MA, Saugel B, Haas S, Reuter DA, Mann O, Dupree A, Schachschal G, Rosch T, Petzoldt M. Anesthetic considerations for patients with esophageal achalasia undergoing peroral endoscopic myotomy: a retrospective case series review. Ca — View Citation
Maunder RJ, Pierson DJ, Hudson LD. Subcutaneous and mediastinal emphysema. Pathophysiology, diagnosis, and management. Arch Intern Med. 1984 Jul;144(7):1447-53. — View Citation
Nishihara Y, Yoshida T, Ooi M, Obata N, Izuta S, Mizobuchi S. Anesthetic management and associated complications of peroral endoscopic myotomy: A case series. World J Gastrointest Endosc. 2018 Sep 16;10(9):193-199. doi: 10.4253/wjge.v10.i9.193. — View Citation
Okada T, Izuta S, Mizobuchi S. A case of ventilatory impairment during per-oral endoscopic myotomy under general anesthesia. JA Clin Rep. 2018 Feb 26;4(1):23. doi: 10.1186/s40981-018-0160-7. — View Citation
Podboy A, Hwang JH, Nguyen LA, Garcia P, Zikos TA, Kamal A, Triadafilopoulos G, Clarke JO. Gastric per-oral endoscopic myotomy: Current status and future directions. World J Gastroenterol. 2019 Jun 7;25(21):2581-2590. doi: 10.3748/wjg.v25.i21.2581. — View Citation
Sosa G, Gandham N, Landeras V, Calimag AP, Lerma E. Abdominal compartment syndrome. Dis Mon. 2019 Jan;65(1):5-19. doi: 10.1016/j.disamonth.2018.04.003. Epub 2018 Nov 17. No abstract available. — View Citation
Werner YB, von Renteln D, Noder T, Schachschal G, Denzer UW, Groth S, Nast JF, Kersten JF, Petzoldt M, Adam G, Mann O, Repici A, Hassan C, Rosch T. Early adverse events of per-oral endoscopic myotomy. Gastrointest Endosc. 2017 Apr;85(4):708-718.e2. doi: 1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Describe in detail the profile of operated patients and the various characteristics of the endoscopic procedure, in the presence or absence of adverse events/complications. | 48 hours | ||
Secondary | Verify the presence of predictable elements of adverse events | 48 hours | ||
Secondary | Look for a correlation between the modifications of the respiratory and hemodynamic parameters with the values of intra-abdominal pressure measured, during the exsufflations by stages of the pneumoperitoneums | 48hours |
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