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The aims of this study is to compare the efficacy and safety of conventional myotomy (circular myotomy) and modified myotomy (full-thickness myotomy) in the treatment of achalasia patients.
Peroral endoscopic myotomy (POEM) is a novel clinical technique used to treat achalasia. The conventional POEM myotomy length averages 8 to 10 cm (4-6 cm in the esophagus, 2-4cm in the LES, 2cm in the cardia & 6-8 cm above and 2 cm below the gastroesophageal junction [GEJ]) for typical achalasia (Chicago classification I, II), with only the inner circular muscle layer incised.
There is still no conclusion on the thickness of muscle bundle dissection recommended during POEM. Selective circular muscle myotomy is designed to avoid gastroesophageal reflux (GER) postoperatively and decrease morbidity during POEM. But one meta-analysis showed that Heller's surgery could keep patients in long-time remission, mainly because of its full-thickness muscle bundle dissection to make sure of persist relaxation of LES. A retrospective study comparing the outcomes of full-thickness and circular muscle myotomy showed no differences in efficacy, GER or adverse events, although the procedural time was shorter in the full thickness myotomy group.
Further randomized controlled trials are warranted to assess the efficacy and safety of different modified myotomy approaches in POEM for patients with achalasia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional myotomy | Active Comparator | conventional myotomy for achalasia type I or II |
|
| full-thickness myotomy | Experimental | modified myotomy (full-thickness myotomy) for achalasia type I or II |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional myotomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic success of short term | Clinical severity was assessed using the Eckardt score. This score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of <5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of >10 kg). The total score ranges from 0 to 12, with higher scores indicating more severe disease symptomatology. (Eckardt, V. Gastroenterology, 1992. 103(6): 1732-8. | 6 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | The duration of the endoscopic procedures for each patients will be calculated, in minutes, since the mucosal incision until the endoscopic closure of the mucosal entry with the last endoscopic clip. | During the endoscopic procedure |
| Pressure changes by high-resolution manometry (HRM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Guo, MD | Contact | 8610-69155017 | guoqiong990@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Tao Guo, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25469569 | Background | Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJ, Pandolfino JE; International High Resolution Manometry Working Group. The Chicago Classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil. 2015 Feb;27(2):160-74. doi: 10.1111/nmo.12477. Epub 2014 Dec 3. | |
| 31559513 | Background |
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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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|
|
| full-thickness myotomy | Procedure |
|
|
|
Basal lower esophageal sphincter (LES) pressure, Distal contractile integral (DCI) and integrated relaxation pressure (IRP) |
| 6 month after the procedure |
| barium esophagogram | Barium swallow studies will be done to evaluate the oesophageal emptying at 5 minutes and esophageal distortion | 6 month after the procedure |
| Rate of intra-procedure complications | Complications encountered during the procedure will be noted. (perforation, delayed bleeding, pneumothorax, subcutaneous emphysema, anastomotic leak etc.) | During the endoscopic procedure |
| the rate and severity of oesophagitis | oesphagitis was identified under esophagogastroduodenoscopy, and was classified according to the Los Angeles Classification | 6 months after the procedure |
| (4) Esophagogastroduodenoscopy (EGD) with the novel Endoscopic Scoring for Achalasia (CARS) | Endoscopic evaluation was performed using the Contents, Anatomy, Resistance, and Stasis (CARS) score. This scoring system was developed and validated through video-based reliability assessments and initially demonstrated strong clinical utility for predicting achalasia. The score assigns 0 to 2 points each for Contents, Anatomy, and Resistance at the lower esophageal sphincter, and 1 point for each component of Stasis. The total score ranges from 0 to 8, with higher scores indicating a worse endoscopic outcome. | 6-month after the procedure |
| POEM difficulty evaluation | ① Peroral Endoscopic Myotomy (POEM) difficulty score (PDS). The score consists of five variables: Fibrosis, Oozing, Orientation, Distension of tunnel, and Spastic contractions ("FOODS"). Each variable was arbitrarily weighted equally and assigned values ranging from 0 to 2. The PDS was completed immediately post-procedure in the operating room. The total score ranges from 0 to 10, with higher scores indicating greater technical difficulty. ② bleeding episodes, classified into (1) none to minimal (2) moderate to diffuse | During the endoscopic procedure |
| perioperative hospitalization | perioperative hospitalization length | perioperative period |
| post-POEM persistent pain | Post-POEM persistent pain was defined as pain requiring level 2 or 3 analgesics. | postoperative period |
| Inoue H, Shiwaku H, Kobayashi Y, Chiu PWY, Hawes RH, Neuhaus H, Costamagna G, Stavropoulos SN, Fukami N, Seewald S, Onimaru M, Minami H, Tanaka S, Shimamura Y, Santi EG, Grimes K, Tajiri H. Statement for gastroesophageal reflux disease after peroral endoscopic myotomy from an international multicenter experience. Esophagus. 2020 Jan;17(1):3-10. doi: 10.1007/s10388-019-00689-6. Epub 2019 Sep 26. |
| 30022514 | Background | Inoue H, Shiwaku H, Iwakiri K, Onimaru M, Kobayashi Y, Minami H, Sato H, Kitano S, Iwakiri R, Omura N, Murakami K, Fukami N, Fujimoto K, Tajiri H. Clinical practice guidelines for peroral endoscopic myotomy. Dig Endosc. 2018 Sep;30(5):563-579. doi: 10.1111/den.13239. |
| 25214469 | Background | Wang J, Tan N, Xiao Y, Chen J, Chen B, Ma Z, Zhang D, Chen M, Cui Y. Safety and efficacy of the modified peroral endoscopic myotomy with shorter myotomy for achalasia patients: a prospective study. Dis Esophagus. 2015 Nov-Dec;28(8):720-7. doi: 10.1111/dote.12280. Epub 2014 Sep 12. |
| 30187204 | Background | Li L, Chai N, Linghu E, Li Z, Du C, Zhang W, Zou J, Xiong Y, Zhang X, Tang P. Safety and efficacy of using a short tunnel versus a standard tunnel for peroral endoscopic myotomy for Ling type IIc and III achalasia: a retrospective study. Surg Endosc. 2019 May;33(5):1394-1402. doi: 10.1007/s00464-018-6414-7. Epub 2018 Sep 5. |
| 30054739 | Background | Kane ED, Budhraja V, Desilets DJ, Romanelli JR. Myotomy length informed by high-resolution esophageal manometry (HREM) results in improved per-oral endoscopic myotomy (POEM) outcomes for type III achalasia. Surg Endosc. 2019 Mar;33(3):886-894. doi: 10.1007/s00464-018-6356-0. Epub 2018 Jul 27. |
| 27895430 | Background | Wang XH, Tan YY, Zhu HY, Li CJ, Liu DL. Full-thickness myotomy is associated with higher rate of postoperative gastroesophageal reflux disease. World J Gastroenterol. 2016 Nov 14;22(42):9419-9426. doi: 10.3748/wjg.v22.i42.9419. |
| 23891074 | Background | Li QL, Chen WF, Zhou PH, Yao LQ, Xu MD, Hu JW, Cai MY, Zhang YQ, Qin WZ, Ren Z. Peroral endoscopic myotomy for the treatment of achalasia: a clinical comparative study of endoscopic full-thickness and circular muscle myotomy. J Am Coll Surg. 2013 Sep;217(3):442-51. doi: 10.1016/j.jamcollsurg.2013.04.033. Epub 2013 Jul 25. |
| D004066 | Digestive System Diseases |