Clinical trial NCT06661668: Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis
Official title: Laparoscopic Implantation of a Gastric Pacemaker is a Low-complication Alternative for Gastroparesis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastroparesis
Gastroparesis Postoperative
Gastroparesis Nondiabetic
Gastroparesis With Diabetes Mellitus
Keywords: Gastroparesis
Gastric pacemaker
Lead sponsor: Evangelic Hospital Kalk Cologne
Sponsor class: OTHER
Collaborators: name: Enterra Medical, Inc.
First posted: 2024-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes patients with (1) scintigraphically proven gastroparesis, (2) failed conservative therapy, (3) who undergo laparoscopic gastric pacemaker implantation.

Brief summary: Gastroparesis is a burdensome condition that is caused by abnormal motor function of the stomach that results in delayed gastric emptying. It typically manifests with bloating, nausea, vomiting, abdominal pain, and even excessive weight loss and dehydration. The most common causes of gastroparesis are idiopathic, diabetic, medication-induced or iatrogenic (postsurgical) gastroparesis.

Implantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life.

Aim of the investogators' registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.

Detailed description: Gastroparesis is a burdensome condition that is caused by abnormal motor function of the stomach that results in delayed gastric emptying. It typically manifests with bloating, nausea, vomiting, abdominal pain, and even excessive weight loss and dehydration. The most common causes of gastroparesis are idiopathic, diabetic, medication-induced or iatrogenic (postsurgical) gastroparesis.

After ruling out mechanical obstruction as an underlying cause of gastroparesis using endoscopy or computed tomography, further assessment includes gastric emptying studies by scintigraphy to confirm the presence of delayed gastric emptying. Severity of symptoms and impact on health-related quality of life can be assessed using the Gastroparesis Cardinal Symptom Index (GCSI) and Gastrointestinal Quality of Life Index (GIQLI).

Management of gastroparesis includes assessment of nutritional status, correction of fluid, electrolytes and nutritional deficiencies, symptomatic therapy, management of the underlying cause of gastroparesis, and improvement of gastric emptying. Implantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life.

Aim of this registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.

It is hypothesized that implantation of the Enterra systems leads to a significant improvement of symptoms as well as an increase in health-related quality of life in patients with gastroparesis.

Eligibility criteria: Inclusion Criteria:

* Scintigraphically proven gastroparesis
* Failed conservative therapy
* Severe impairment of quality of life
* Written informed consent
* German language

Exclusion Criteria:

* Age \< 18 years
* Prior gastric resection

Primary outcomes:
measure: Symptoms
timeFrame: 5 years
measure: Health-related quality of life
timeFrame: 5 years
Secondary outcomes:
measure: Hospital admission
timeFrame: 5 years
measure: Perioperative complication rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Functional Upper GI Surgery
state: NRW
Study officials:
affiliation: Department of Functional Upper GI Surgery
name: Jessica M Leers, Prof.
role: PRINCIPAL_INVESTIGATOR
References: