Pneumodilation versus Per-Oral Endoscopic Myotomy in Achalasia patients with recurrent symptoms after Laparoscopic Heller Myotomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25721

Enrollment

Registered

2014-04-01

Start date

2014-05-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

achalasia Per-oral endoscopic myotomy Relapse Pneumodilation Secondary treatment Laparoscopic Heller Myotomy

Interventions

per-oral endoscopic myotomy (intervention)

Eligibility

Inclusion criteria

Inclusion criteria: 1. Presence of achalasia as shown on oesophageal manometry at least once 2. Previous Heller myotomy 3. Eckardt score > 3 4. Significant stasis (stasis of >2 cm on barium oesophagogram after two minutes) 5. Age between 18-80 years 6. Signed written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous pneumodilations after the Heller myotomy (pneumodilations before the Heller myotomy are allowed) 2. Previous (attempt at) POEM 3. Previous surgery of the stomach or oesophagus, except Heller myotomy 4. Known coagulopathy 5. Presence of liver cirrhosis and/or oesophageal varices 6. Presence of eosinophilic oesophagitis 7. Pregnancy at time of treatment 8. Presence of a stricture of the oesophagus 9. Presence of malignant or premalignant oesophageal lesions 10. Presence of one or more large esophageal diverticuli

Design outcomes

Primary

Measure	Time frame
-Treatment success at one year, defined as: An Eckardt score of 3 or less in the absence of additional retreatment after the allocated treatment (patients in the pneumodilation arm undergo 2 pneumodilations, with 30 and 35 mm and another one or two pneumodilations are allowing up to 40 mm in case of symptom recurrence within 1 year), patients in the POEM arm undergo POEM and no subsequent treatments)	—

Measure

Time frame

-Treatment success at one year, defined as: An Eckardt score of 3 or less in the absence of additional retreatment after the allocated treatment (patients in the pneumodilation arm undergo 2 pneumodilations, with 30 and 35 mm and another one or two pneumodilations are allowing up to 40 mm in case of symptom recurrence within 1 year), patients in the POEM arm undergo POEM and no subsequent treatments)

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Secondary

Measure	Time frame
• Quality of life and achalasia-specific quality of life • Stasis in the oesophagus, measured with a timed barium oesophagogram • Complications of the treatment, defined as any unwanted events that arise following treatment and/or that are secondary to the treatment. Complications are classified as 'severe' when these result in admission > 24 hours or prolongation of an already planned admission of >24 hours, admission to a medium or intensive care unit, additional endoscopic procedures, or blood transfusion or death. Other complications are classified as 'mild'. • Treatment success after two and five years follow up • The use of acid-suppressant drugs and the presence of reflux symptoms using the GerdQ questionnaire • The presence of reflux oesophagitis, as observed during upper endoscopy	—

Measure

Time frame

• Quality of life and achalasia-specific quality of life • Stasis in the oesophagus, measured with a timed barium oesophagogram • Complications of the treatment, defined as any unwanted events that arise following treatment and/or that are secondary to the treatment. Complications are classified as 'severe' when these result in admission > 24 hours or prolongation of an already planned admission of >24 hours, admission to a medium or intensive care unit, additional endoscopic procedures, or blood transfusion or death. Other complications are classified as 'mild'. • Treatment success after two and five years follow up • The use of acid-suppressant drugs and the presence of reflux symptoms using the GerdQ questionnaire • The presence of reflux oesophagitis, as observed during upper endoscopy

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Contacts

Public ContactA.J. Bredenoord

Meibergdreef 9

a.j.bredenoord@amc.nl+31 (0)20 5661745

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)