To Investigate the Incidence of Reflux in Patients After Per-oral Endoscopic Myotomy in Achalasia Cardia Patients

NCT04951739 | Completed DMC

• 1 other identifier: AIG/IEC-BH&R 13/05.2021-01
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Achalasia is a rare motility disorder of the oesophagus that is characterized by aperistalsis of the oesophagal body and dysrelaxation of the lower oesophagal sphincter (LES). Current treatment is palliative, and the aim of the treatment is to diminish the obstructive function of the esophagogastric junction (EGJ). Due to this approach, the most frequent complication post-treatment is gastroesophageal reflux (GER). However, not every treated patient develops GER symptoms and the mechanism behind the occurrence of GER in treated achalasia are unclear. In this study, we aim to Investigate the incidence of reflux in patients after peroral endoscopic myotomy in patients with achalasia cardia.

Conditions

Achalasia Cardia; Gastroesophageal Reflux

Keywords

Achalasia cardia; Peroral endoscopic myotomy; Gastroesophageal Reflux; oesophageal pH study; oesophageal acidification; High resolution manometry

Outcome Measures

Primary Outcomes (1)

• To Investigate the incidence of reflux in patients after peroral endoscopic myotomy in achalasia cardia patients.

  To study the incidence of true reflux in patients with achalasia cardia who have undergone peroral endoscopic myotomy with 24 hour ambulatory pH monitoring.

  Three months

Study Arms (1)

Achalasia cardia patients - post peroral endoscopic myotomy

All the patients who will undergo peroral endoscopic myotomy for the treatment of achalasia cardia patients.

Procedure: Peroral endoscopic myotomy

Interventions

Peroral endoscopic myotomy PROCEDURE

Peroral endoscopic myotomy involves an initial incision on the internal lining of the oesophagus. This permits entry of the endoscope to within the wall of the oesophagus, where the muscle will be exposed. The inner layer of the muscle near the lower oesophagal sphincter will be cut (this is termed myotomy). At the conclusion of the procedure, the oesophagal incision will be closed with standard endoscopic clips.

Achalasia cardia patients - post peroral endoscopic myotomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Treated achalasia patients with and without gastroesophageal reflux symptoms visiting the outpatient clinic of the Gastroenterology Department.

You may qualify if:

• A- Treated achalasia patients with gastroesophageal reflux symptoms
• Diagnosis of idiopathic achalasia confirmed by oesophageal manometry that shows the following criteria:
• Aperistalsis or simultaneous contractions in the oesophageal body.
• Impaired relaxation of the Lower oesophageal sphincter
• Treatment of achalasia with per-oral endoscopic myotomy (POEM)
• The minimum total score on the Gastroesophageal Reflux Disease Questionnaire (GERDQ) of ≥ 8.
• Gastroesophageal symptoms after treatment lasting more than three months.
• Age 18-80 years.
• Written informed consent.
• B- Treated achalasia patients without gastroesophageal reflux symptoms
• Diagnosis of idiopathic achalasia confirmed by oesophagal manometry that shows the following criteria:
• Aperistalsis or simultaneous contractions in the oesophageal body.
• Impaired relaxation of the Lower oesophageal sphincter
• Treatment of achalasia with per-oral endoscopic myotomy (POEM)
• The maximum total score on the Gastroesophageal Reflux Disease Questionnaire (GERDQ) of \< 8.

You may not qualify if:

• Pseudoachalasia.
• Upper gastrointestinal malignancy.
• Chagas disease.
• Peptic ulcer disease.
• Inability to stop PPI, H2-receptor antagonist or prokinetic drug for two weeks
• Presence of an extremely dilated oesophagus body \>5 cm

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

AIG Hospitals

Hyderabad, Telangana, 500032, India

Location

Related Publications (18)

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  PMID: 15836451 RESULT

• Campos GM, Vittinghoff E, Rabl C, Takata M, Gadenstatter M, Lin F, Ciovica R. Endoscopic and surgical treatments for achalasia: a systematic review and meta-analysis. Ann Surg. 2009 Jan;249(1):45-57. doi: 10.1097/SLA.0b013e31818e43ab.

  PMID: 19106675 RESULT

• Lopushinsky SR, Urbach DR. Pneumatic dilatation and surgical myotomy for achalasia. JAMA. 2006 Nov 8;296(18):2227-33. doi: 10.1001/jama.296.18.2227.

  PMID: 17090769 RESULT

• Anderson SH, Yadegarfar G, Arastu MH, Anggiansah R, Anggiansah A. The relationship between gastro-oesophageal reflux symptoms and achalasia. Eur J Gastroenterol Hepatol. 2006 Apr;18(4):369-74. doi: 10.1097/00042737-200604000-00009.

  PMID: 16538107 RESULT

• Crookes PF, Corkill S, DeMeester TR. Gastroesophageal reflux in achalasia. When is reflux really reflux? Dig Dis Sci. 1997 Jul;42(7):1354-61. doi: 10.1023/a:1018873501205.

  PMID: 9246028 RESULT

• van Herwaarden MA, Samsom M, Smout AJ. Prolonged manometric recordings of oesophagus and lower oesophageal sphincter in achalasia patients. Gut. 2001 Dec;49(6):813-21. doi: 10.1136/gut.49.6.813.

  PMID: 11709516 RESULT

• Shoenut JP, Micflikier AB, Yaffe CS, Den Boer B, Teskey JM. Reflux in untreated achalasia patients. J Clin Gastroenterol. 1995 Jan;20(1):6-11. doi: 10.1097/00004836-199501000-00004.

  PMID: 7884182 RESULT

• Katzka DA, Sidhu M, Castell DO. Hypertensive lower esophageal sphincter pressures and gastroesophageal reflux: an apparent paradox that is not unusual. Am J Gastroenterol. 1995 Feb;90(2):280-4.

  PMID: 7847301 RESULT

• Novais PA, Lemme EM. 24-h pH monitoring patterns and clinical response after achalasia treatment with pneumatic dilation or laparoscopic Heller myotomy. Aliment Pharmacol Ther. 2010 Nov;32(10):1257-65. doi: 10.1111/j.1365-2036.2010.04461.x. Epub 2010 Sep 25.

  PMID: 20955445 RESULT

• Shoenut JP, Duerksen D, Yaffe CS. A prospective assessment of gastroesophageal reflux before and after treatment of achalasia patients: pneumatic dilation versus transthoracic limited myotomy. Am J Gastroenterol. 1997 Jul;92(7):1109-12.

  PMID: 9219779 RESULT

• Spechler SJ, Souza RF, Rosenberg SJ, Ruben RA, Goyal RK. Heartburn in patients with achalasia. Gut. 1995 Sep;37(3):305-8. doi: 10.1136/gut.37.3.305.

  PMID: 7590421 RESULT

• Eckardt VF, Aignherr C, Bernhard G. Predictors of outcome in patients with achalasia treated by pneumatic dilation. Gastroenterology. 1992 Dec;103(6):1732-8. doi: 10.1016/0016-5085(92)91428-7.

  PMID: 1451966 RESULT

• Rohof WO, Hirsch DP, Kessing BF, Boeckxstaens GE. Efficacy of treatment for patients with achalasia depends on the distensibility of the esophagogastric junction. Gastroenterology. 2012 Aug;143(2):328-35. doi: 10.1053/j.gastro.2012.04.048. Epub 2012 May 2.

  PMID: 22562023 RESULT

• Rohof WO, Lei A, Boeckxstaens GE. Esophageal stasis on a timed barium esophagogram predicts recurrent symptoms in patients with long-standing achalasia. Am J Gastroenterol. 2013 Jan;108(1):49-55. doi: 10.1038/ajg.2012.318. Epub 2012 Sep 25.

  PMID: 23007004 RESULT

• Vaezi MF, Baker ME, Achkar E, Richter JE. Timed barium oesophagram: better predictor of long term success after pneumatic dilation in achalasia than symptom assessment. Gut. 2002 Jun;50(6):765-70. doi: 10.1136/gut.50.6.765.

  PMID: 12010876 RESULT

• Kwiatek MA, Kahrilas K, Soper NJ, Bulsiewicz WJ, McMahon BP, Gregersen H, Pandolfino JE. Esophagogastric junction distensibility after fundoplication assessed with a novel functional luminal imaging probe. J Gastrointest Surg. 2010 Feb;14(2):268-76. doi: 10.1007/s11605-009-1086-1.

  PMID: 19911238 RESULT

• Hemmink GJ, Bredenoord AJ, Weusten BL, Timmer R, Smout AJ. Does acute psychological stress increase perception of oesophageal acid? Neurogastroenterol Motil. 2009 Oct;21(10):1055-e86. doi: 10.1111/j.1365-2982.2009.01327.x. Epub 2009 May 15.

  PMID: 19453516 RESULT

• Singh AP, Singla N, Budhwani E, Januszewicz W, Memon SF, Inavolu P, Nabi Z, Jagtap N, Kalapala R, Lakhtakia S, Darisetty S, Reddy DN, Ramchandani M. Defining "true acid reflux" after peroral endoscopic myotomy for achalasia: a prospective cohort study. Gastrointest Endosc. 2024 Feb;99(2):166-173.e3. doi: 10.1016/j.gie.2023.08.008. Epub 2023 Aug 19.

  PMID: 37598862 DERIVED

MeSH Terms

Conditions

Esophageal Achalasia; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Aniruddha P Singh, MBBS,MD,DM

  AIG hospitals,India

  PRINCIPAL INVESTIGATOR

• Mohan Ramchandani, MBBS,MD,DM

  AIG Hospitals,India

  STUDY DIRECTOR

• Nageshwar Reddy, MBBS,MD,DM

  AIG Hospitals,India

  STUDY CHAIR

• Pradev Inavolu, MBBS, MD, DM

  AIG Hospitals, India

  PRINCIPAL INVESTIGATOR

• Hardik Rughwani, MBBS, MD, DM

  AIG Hospitals, India

  PRINCIPAL INVESTIGATOR

• Neeraj Singla, MBBS, MD, DM

  AIG Hospitals, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: July 7, 2021
• Study Start: July 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: March 15, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

IN (1)