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German G-POEM Trial

Organizational Data

DRKS-ID:
DRKS00033295
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2024-01-18
Last update in DRKS:
2024-01-18
Registration type:
Prospective

Acronym/abbreviation of the study

gGPT

URL of the study

No Entry

Brief summary in lay language

No Entry

Brief summary in scientific language

The aim of the gGPT-Trial is to create a valid data basis for European patients with therapy refractory gastroparesis for the first time. According to this it will be possible to conduct an evaluation of safety and success of this relatively new endoscopic G-POEM procedure. Initially we will collect retrospective data of G-POEMs in Germany, Austria and Switzerland performed in the last 5 years. After that we will conduct a prospective trial with a two years follow- up period. The focus will be the long term clinical success of a G-POEM in dependence on the etiology of gastroparesis and its predominant symptom (GCSI-score). Further more the EQ-5D-5L questionnaire will be used to investigate the change in life quality due to endoscopic intervention. With this results it may be possible to draw some conclusion whether there is some correlation between the etiology (diabetic, idiopathic or post-surgical) and clinical success after G-POEM or whether there are some diagnostic predictors (GCSI-Score, GES, Endoflip) that can foresee better results. It may be possible to gain deeper insights of pathophysiological changes in gastroparesis. Last but not least, this trial collects lots of data about technical performance, costs, adverse events frequencies - dependent on yearly conducted interventions - and postinterventional processes to make recommendations of a better planning, performance and follow-up.

Health condition or problem studied

ICD10:
K31.3 - Pylorospasm, not elsewhere classified
ICD10:
K31.8 - Other specified diseases of stomach and duodenum
ICD10:
G99.0 - Autonomic neuropathy in endocrine and metabolic diseases
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
pre-interventional: upper GI-Endoscopy, objective gastric emptying study (C13-Breath-test, Gastric scintigraphy), if available Endo-Flip; EQ-5L-5D Trial begin: gastric peroral endoscopic myotomy post-interventional 3-6 month: GCSI-Score, objective gastric emptying study (C13-Breath-test, Gastric scintigraphy), if available Endo-Flip; EQ-5L-5D post-interventional 12 month: objective gastric emptying study (C13-Breath-test, Gastric scintigraphy), if available Endo-Flip; post-interventional 24 month: objective gastric emptying study (C13-Breath-test, Gastric scintigraphy), if available Endo-Flip; EQ-5L-5D

Endpoints

Primary outcome:
Clinical success- reduction of GSCI-Score about 1 point of total score or reduction of at least 25% of two subscales after 3-6, 12 and 24 month.
Secondary outcome:
absolute and relativ reduction of gastric emptying delay measured with an objective gastric emptying study adverse events frequency technical succress Change of life quality (EQ-5L-SD)

Study Design

Purpose:
Treatment
Retrospective/prospective:
Both
Study type:
Non-interventional
Longitudinal/cross-sectional:
Longitudinal study
Study type non-interventional:
Patient Registry

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Austria
  • Germany
  • Switzerland
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Augsburg 86150

Recruitment period and number of participants

Planned study start date:
2024-04-01
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
300
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
patients with gastroparesis, which is diagnosed with an objective gastric emptying study (C13-breath test, gastric emptying scintigraphy) and GCSI-Score over 0 patient will or have received a G-POEM procedure

Exclusion Criteria

Patient denies follow-up Patient with gastroparesis without symptoms (GCSI Score = 0) Gastric emptying delay due to other circumstances excluding gastroparesis disease Patient unable to consent

Addresses

Primary Sponsor

Universitätsklinikum Augsburg
86156 Augsburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum Augsburg
PD Dr. Alanna Ebigbo
Stenglinstraße 2
86156 Augsburg
Germany
Telephone:
+49821400161893
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsklinikum Augsburg
PD Dr. Alanna Ebigbo
Stenglinstraße 2
86156 Augsburg
Germany
Telephone:
+49821400161893
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinikum Augsburg
PD Dr. Alanna Ebigbo
Stenglinstraße 2
86156 Augsburg
Germany
Telephone:
+49821400161893
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Universitätsklinikum Augsburg
86156 Augsburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Universität Regensburg
Landshuter Straße 4
93047 Regensburg
Germany
Telephone:
+49-941-9435370
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uni-regensburg.de/ethikkommission/startseite/index.html

Vote of leading Ethics Committee

Date of ethics committee application:
2023-06-20
Ethics committee number:
23-3421-101
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-07-26

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED 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:
No Entry
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