Esophageal Achalasia Clinical Trial
Official title:
Peroral Endoscopic Remyotomy for Failed Heller Myotomy
Achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. With respect to long-term efficacy, Heller myotomy (HM) using an open or a laparoscopic approach has gained wide acceptance as the procedure of choice for the management of patients with primary achalasia in recent years. Although good or excellent long-term symptomatic response rates can be achieved in more than 90% of patients undergoing HM, recurrence or persistence of symptoms occurs in approximately 20%. Controversy exists regarding the therapy of patients with failed success after HM. Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia. Our purpose was to evaluate the efficacy and the feasibility of POEM for patients with failed HM.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2014 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age greater than 18 years - Recurrence/persistence of symptoms after primary HM with an Eckardt symptom score = 4 - The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy) Exclusion Criteria: - Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk - Pseudoachalasia - megaesophagus (diameter of > 7 cm) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
Duffy PE, Awad ZT, Filipi CJ. The laparoscopic reoperation of failed Heller myotomy. Surg Endosc. 2003 Jul;17(7):1046-9. Epub 2003 May 7. — View Citation
Eckardt AJ, Eckardt VF. Treatment and surveillance strategies in achalasia: an update. Nat Rev Gastroenterol Hepatol. 2011 Jun;8(6):311-9. doi: 10.1038/nrgastro.2011.68. Epub 2011 Apr 26. Review. — View Citation
Gockel I, Junginger T, Eckardt VF. Persistent and recurrent achalasia after Heller myotomy: analysis of different patterns and long-term results of reoperation. Arch Surg. 2007 Nov;142(11):1093-7. — View Citation
Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30. — View Citation
Iqbal A, Tierney B, Haider M, Salinas VK, Karu A, Turaga KK, Mittal SK, Filipi CJ. Laparoscopic re-operation for failed Heller myotomy. Dis Esophagus. 2006;19(3):193-9. — View Citation
Rakita S, Villadolid D, Kalipersad C, Thometz D, Rosemurgy A. Outcomes promote reoperative Heller myotomy for symptoms of achalasia. Surg Endosc. 2007 Oct;21(10):1709-14. Epub 2007 Apr 14. — View Citation
Ren Z, Zhong Y, Zhou P, Xu M, Cai M, Li L, Shi Q, Yao L. Perioperative management and treatment for complications during and after peroral endoscopic myotomy (POEM) for esophageal achalasia (EA) (data from 119 cases). Surg Endosc. 2012 Nov;26(11):3267-72. — View Citation
von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rösch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3) — View Citation
Zaninotto G, Costantini M, Portale G, Battaglia G, Molena D, Carta A, Costantino M, Nicoletti L, Ancona E. Etiology, diagnosis, and treatment of failures after laparoscopic Heller myotomy for achalasia. Ann Surg. 2002 Feb;235(2):186-92. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Therapeutic success (a reduction in the Eckardt score to =3) | Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires. | Yes | |
Secondary | Procedure-related adverse events | All patients were scheduled for a follow-up visit at 1 month after POEM for EGD. | Yes | |
Secondary | Lower esophageal sphincter (LES) pressure on manometry | All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry | No | |
Secondary | Reflux symptoms and medication use before and after POEM | Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires. | Yes |
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