NCT05602272

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

October 27, 2022

Last Update Submit

February 6, 2023

Conditions

Esophageal AchalasiaGastroparesis

Keywords

AnesthesiaPneumoperitoneumPOEMGPOEM

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Verify the presence of predictable elements of adverse events

    48 hours

  • 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

Interventions

General anesthesia for per-oral endoscopic myotomyPROCEDURE

Intra-abdominal pressure measurement

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with achalasia or gastroparesis who are summoned for POEM or GPOEM type endoscopy treatment at the Lausanne University Hospital.

You may qualify if:

  • 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

You may not qualify if:

  • \- Inability to follow study procedures, eg. due to language problems, psychological disorders, dementia, etc. of the participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (10)

  • 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.

    PMID: 31288505RESULT

  • 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.

    PMID: 28840505RESULT

  • 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.

    PMID: 27625490RESULT

  • 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. Can J Anaesth. 2017 May;64(5):480-488. doi: 10.1007/s12630-017-0820-5. Epub 2017 Jan 23.

    PMID: 28116675RESULT

  • 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.

    PMID: 30283602RESULT

  • 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.

    PMID: 32026954RESULT

  • 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.

    PMID: 31210711RESULT

  • 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.

    PMID: 30454823RESULT

  • 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: 10.1016/j.gie.2016.08.033. Epub 2016 Sep 5.

    PMID: 27609778RESULT

  • Maunder RJ, Pierson DJ, Hudson LD. Subcutaneous and mediastinal emphysema. Pathophysiology, diagnosis, and management. Arch Intern Med. 1984 Jul;144(7):1447-53.

    PMID: 6375617RESULT

MeSH Terms

Conditions

Esophageal AchalasiaGastroparesisPneumoperitoneum

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeritoneal Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Madeleine Chollet-Rivier

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aldo Cavuoto

CONTACT

795565766aldo.cavuoto@chuv.ch

Madeleine Chollet-Rivier, Dr

CONTACT

795567214madeleine.chollet-rivier@chuv.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician of anesthesiology department

Study Record Dates

First Submitted

October 27, 2022

First Posted

November 2, 2022

Study Start

November 1, 2022

Primary Completion

November 1, 2024

Study Completion

November 1, 2025

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)