Gastroparesis Clinical Trial
Official title:
Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.
Gastroparesis is a common chronic condition, disabling the limited therapeutic resources
justifying the exploration of new therapeutic possibilities.
By analogy to the technique of Per Oral Endoscopic Myotomy (POEM), we believe that myotomy
pyloric muscle (POP = Per Oral Pyloromyotomy) endoscopically could become a treatment of
choice in the refractory gastroparesis with drug treatments by attacking the pyloric obstacle
often spastic that counteracts an effective gastric emptying.
Experimental study, prospective, single-center, POP feasibility pilot in the treatment of
refractory gastroparesis.
Patients with gastroparesis (significant prolongation of gastric emptying) unimproved by
prokinetic treatment and meet all the eligibility criteria will be included after a period of
reflection of two weeks minimum.
20 patients will be prospectively included 10 patients with diabetic gastroparesis, 10
patients with non-diabetic gastroparesis (post-surgical, post-Sjogren, idiopathic).
POP will be performed under general anesthesia in intubated-ventilated patients using a
carbon dioxide (CO2) inflator. The published standard technique and learned by our team on
the pig model will be conducted: submucosal tunnel at the anterior surface of the gastric
antrum starting 3-5 cm proximal to the pylorus front section to the fiber by fiber to the
muscular pyloric, then closing the inlet tunnel by hemostatic clips.
An evaluation of symptoms by the Gastroparesis Cardinal Symptom Index (ISCC) of the quality
of life of the patient Assessment of upper gastrointestinal disorders-Quality Of Life
(PAGI-QoL), SF-36 and gastrointestinal Quality of Life Index (GIQLI ) and gastric emptying by
a scintigraphic gastric emptying will be carried out at 3 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03941288 -
Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia
|
Phase 2 | |
| Terminated |
NCT03285308 -
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
|
Phase 3 | |
| Completed |
NCT00733551 -
Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK962040 Administered to Healthy Adult Subjects.
|
Phase 1 | |
| Completed |
NCT01650714 -
Endoscopic Full Thickness Biopsy, Gastric Wall.
|
N/A | |
| Completed |
NCT01452815 -
Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis
|
Phase 2 | |
| Completed |
NCT01039974 -
GSK962040 Drug-drug Interaction Study With Ketoconazole
|
Phase 1 | |
| Terminated |
NCT04844190 -
Use of EndoFLIP and Manometry Prior to G-POEM
|
N/A | |
| Enrolling by invitation |
NCT06215547 -
Medtronic Enterra II Neurostimulator
|
N/A | |
| Completed |
NCT04026997 -
A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
|
Phase 2 | |
| Completed |
NCT00562848 -
A Study to Evaluate Safety, Side Effects, Muscle Activity and Speed of Gastric Emptying of GSK962040
|
Phase 1 | |
| Enrolling by invitation |
NCT04207996 -
Vagus Nerve Response in Gastroparesis Patients
|
||
| Completed |
NCT04607304 -
ABCA2 GIRMS Analytical Validation Clinical Performance Study
|
N/A | |
| Recruiting |
NCT06068114 -
Gastric Pathophysiology in Diabetes
|
||
| Completed |
NCT03259841 -
Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy
|
||
| Active, not recruiting |
NCT04300127 -
Pioglitazone for Idiopathic Gastroparesis
|
Early Phase 1 | |
| Recruiting |
NCT01696734 -
Domperidone in Treating Patients With Gastrointestinal Disorders
|
Phase 3 | |
| Terminated |
NCT04635306 -
13C-Spirulina Nitrogen Content GEBT Study
|
N/A | |
| Withdrawn |
NCT02420925 -
Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis
|
N/A | |
| Recruiting |
NCT00777439 -
Domperidone for Refractory Gastrointestinal Disorders
|
N/A | |
| Terminated |
NCT00760461 -
Domperidone in Refractory Gastroparesis
|
Phase 2 |