Pyloric Endoscopic Myotomy as treatment for patients with symptom of gastric outlet obstruction after oesophagectomy with gastric conduit.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22297

Enrollment

Registered

2020-02-03

Start date

2020-04-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed gastric empyting after oesophagectomy with gastric tube reconstruction.

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Previous oesophagectomy with gastric tube reconstruction (>3 months earlier) 2. Age between 18-90 years. 3. Presence of delayed gastric emptying based on symptoms and at least one of the fol-lowing objective parameters indicating delayed gastric emptying: a. Delayed gastric emptying on nuclear scintigraphy, b. Delayed gastric emptying on timed barium swallow, c. Retention of solids in the gastric tube seen during gastroduodenoscopy, and/or d. Good symptomatic response on botulinum toxin injection into the pylorus (re-sponse lasted at least 2 months). 4. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous surgical drainage (pyloroplasty or pyloromyotomy). 2. Previous (attempt at) G-POEM. 3. Uncontrolled coagulopathy. 4. Prognosis qua ad vitam <2 years.

Design outcomes

Primary

Measure	Time frame
1.Efficacy of G-POEM defined as success rate at 3 months, reported as patient reported outcome measurements (PROMS) using a 6 point likert scale, answer-ing the question: “How do you rate your symptoms after the G-POEM procedure as compared to the situation before the procedure?” 1. symptoms fully disap-peared, 2. significant improvement, 3. mild improvement, 4. no change, 5. bit worse, 6. significantly worse. A score of 1 or 2 is considered clinical success. 2.Feasibility of G-POEM defined as technical success of G-POEM procedure (i.e. the ability to perform a complete pyloromyotomy). 3.Safety of G-POEM based on: -Peri-operative G-POEM complications: perforation, bleeding, cardiopulmonary events. -All severe adverse events (SAEs) defined as any unwanted events occurring within 5 days after G-POEM resulting in >72 hours prolonged admission, ad-mission to a medium or intensive care unit, additional unplanned endoscopic procedures, unplanned radiological (e.g. coiling) or surgical interventions, or blood transfusion or death.	—

Measure

Time frame

1.Efficacy of G-POEM defined as success rate at 3 months, reported as patient reported outcome measurements (PROMS) using a 6 point likert scale, answer-ing the question: “How do you rate your symptoms after the G-POEM procedure as compared to the situation before the procedure?” 1. symptoms fully disap-peared, 2. significant improvement, 3. mild improvement, 4. no change, 5. bit worse, 6. significantly worse. A score of 1 or 2 is considered clinical success. 2.Feasibility of G-POEM defined as technical success of G-POEM procedure (i.e. the ability to perform a complete pyloromyotomy). 3.Safety of G-POEM based on: -Peri-operative G-POEM complications: perforation, bleeding, cardiopulmonary events. -All severe adverse events (SAEs) defined as any unwanted events occurring within 5 days after G-POEM resulting in >72 hours prolonged admission, ad-mission to a medium or intensive care unit, additional unplanned endoscopic procedures, unplanned radiological (e.g. coiling) or surgical interventions, or blood transfusion or death.

—

Secondary

Measure	Time frame
8.1.2 Secondary study parameters/endpoints 1. Durability of G-POEM, defined as the clinical success rate at 12 months reported as PROMs (see main study parameter 1). 2. Success rate at 3 and 12 months based on: - Objective parameters: post-G-POEM gastric emptying time on nuclear scintigraphy, post-G-POEM gastric emptying time on barium swallow, post-G-POEM EndoFlip measurement, post-G-POEM gastroduodenoscopy findings. - Subjective parameters: Gastric Cardinal Symptom Index (GCSI), dumping symptom score, regurgitation symptom score. 3. Possible predictors for success or failure of G-POEM, based on: - Objective parameters: pre-G-POEM gastric emptying times on nuclear scintig-raphy, pre-G-POEM gastric emptying on barium swallow, pre-G-POEM EndoFlip, pre-G-POEM gastroduodenoscopy (e.g. retention and/or dilation of gastric tube), previous success on BOTOX injection. - Subjective parameters (patient reported outcomes): Gastric Cardinal Symp-tom Index (GCSI), dumping symptom score, regurgitation symptom score. 4. Adverse events (AEs) defined as any unwanted events that arise following treatment and/or that are secondary to the treatment; events classified as severe adverse events (SAEs) are mentioned as primary endpoint. 5. (changes in) Quality of life, based on SF-36 questionnaire.	—

Measure

Time frame

8.1.2 Secondary study parameters/endpoints 1. Durability of G-POEM, defined as the clinical success rate at 12 months reported as PROMs (see main study parameter 1). 2. Success rate at 3 and 12 months based on: - Objective parameters: post-G-POEM gastric emptying time on nuclear scintigraphy, post-G-POEM gastric emptying time on barium swallow, post-G-POEM EndoFlip measurement, post-G-POEM gastroduodenoscopy findings. - Subjective parameters: Gastric Cardinal Symptom Index (GCSI), dumping symptom score, regurgitation symptom score. 3. Possible predictors for success or failure of G-POEM, based on: - Objective parameters: pre-G-POEM gastric emptying times on nuclear scintig-raphy, pre-G-POEM gastric emptying on barium swallow, pre-G-POEM EndoFlip, pre-G-POEM gastroduodenoscopy (e.g. retention and/or dilation of gastric tube), previous success on BOTOX injection. - Subjective parameters (patient reported outcomes): Gastric Cardinal Symp-tom Index (GCSI), dumping symptom score, regurgitation symptom score. 4. Adverse events (AEs) defined as any unwanted events that arise following treatment and/or that are secondary to the treatment; events classified as severe adverse events (SAEs) are mentioned as primary endpoint. 5. (changes in) Quality of life, based on SF-36 questionnaire.

—

Contacts

Public ContactCaroline Saleh

Universitair Medisch Centrum Utrecht

c.m.g.saleh-2@umcutrecht.nl+3188 7571885

Outcome results