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Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.
Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C).
Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).
Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water-jet POEM | Active Comparator | POEM were performed by the use of Erbe Hybrid knife (WJ group) |
|
| Conventional POEM | Active Comparator | POEM were performed by the conventional technique using injection and triangle tip knife (C group). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water-jet POEM | Procedure | Water-jet assisted POEM procedure was performed |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time in both groups | during POEM procedure |
| Measure | Description | Time Frame |
|---|---|---|
| clinical efficacy and safety | bleeding complications, pneumothorax or pleural effusion requiring intervention | during hospital stay and up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic success | a reduction in the Eckardt score to ≤3 | Every 3 months after innitial intervention via telephone questionnaires during follow-up up to 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping-Hong Zhou, M.D, PhD | Contact | 86-13681971063 | zhou1968@yahoo.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ping-Hong Zhou, M.D., PhD | Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24232052 | Derived | Cai MY, Zhou PH, Yao LQ, Xu MD, Zhong YS, Li QL, Chen WF, Hu JW, Cui Z, Zhu BQ. Peroral endoscopic myotomy for idiopathic achalasia: randomized comparison of water-jet assisted versus conventional dissection technique. Surg Endosc. 2014 Apr;28(4):1158-65. doi: 10.1007/s00464-013-3300-1. |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Conventional POEM |
| Procedure |
POEM were performed by the use of conventional technique using injection and triangle tip knife. |
|
| D004066 | Digestive System Diseases |