VHJOE Editor:

John Deutsch, MD
St. Mary's Duluth Clinic

Editorial Board:

Manoop S. Bhutani, MD
University of Texas
Medical Branch

William R. Brugge, MD
Massachusetts General Hospital

Peter R. McNally, DO
Denver, CO

Thomas J. Savides, MD
University of California,
San Diego

C. Mel Wilcox, MD
University of Alabama, Birmingham

Four-day Bravo pH capsule monitoring with and without proton pump inhibitor therapy.

Hirano I, Zhang Q, Pandolfino JE, and Kahrilas PJ.
Clinical Gastroenterology and Hepatology 2005;3:1083-1088

Ambulatory pH testing is considered the most objective means of diagnosing gastroesophageal reflux disease (GERD). Limitations of conventional catheter-based pH testing include patient tolerance, potential for catheter migration, and limitation of “usual” patient physiologic and dietary activity. The Bravo wireless pH capsule (Medtronic, Shoreview, MN) has overcome these barriers and has the additional advantage of allowing for 48+ hour recording periods.

Ambulatory pH testing is often used to guide the management of reflux symptoms that do not respond to proton pump inhibitor (PPI) therapy and to evaluate the contribution of acid reflux to atypical reflux symptoms (chest pain, cough, hoarseness, throat tightness and asthma). Controversy exists on whether such clinical studies should be conducted on or off PPI. This pilot study aimed to evaluate the feasibility of 4-day pH recordings using a single Bravo pH capsule, encompassing the pre and intra-treatment periods with PPI.

18 patients with variety of symptoms to include refractory GERD, chest pain, or chronic cough were included in the study. Using two separate receivers calibrated to a single Bravo pH capsule -- 4 day monitoring. Rabeprazole was administered on days 2-4 of the study (20 mg orally twice daily)

  • % time pH < 4 per 24 hrs
  • Symptom index score
  • Correlation symptoms & acid reflux
  • Effect of Rabebrazole on acid reflux events Day 2, 3, 4.

Bravo pH capsule functioned for 4 days in 16 of 18 (89%) patients (capsule detachment at day-2 in one patient and day-3 in another). 9 of 16 (53%) of patients had acid exposure exceeding 4% on day-1. Patients showed significant and progressive reductions in acid exposure on days 2-4 of the recording period. Six of 7 (87%) patients with abnormal acid reflux exposure on day-1, normalized by day-3.

  • 7 pts with chest pain
    1/7 had >50% correlation acid events and pain
  • 3 pts with chronic cough
    0/3 had correlation with acid events and cough
  • 7 pts with refractoty heartburn
    1/7 patients failed to normalize acid exposure after 4 days of Rabebrazole

Prolonged esophageal pH recording using the Bravo pH system is feasible. Prolonged pH recording will allow for testing both off and on a therapeutic trial of PPI.

We can anticipate more studies using this prolonged pH capsule testing among patients with:

  • Persistent GERD symptoms despite use of PPI
  • Atypical GERD (chest pain, asthma, hoarseness, globus)
  • Severe erosive GERD
  • Barrett’s esophagus
  • Recurrent Peptic stricture

This novel study by the North Western University GI Group lead by Dr. Peter Kahrilas, provides an ingenuous application of a new technology to perform prolonged intra-esophaegal pH monitoring of patients with acid reflux. The Four-Day Bravo pH capsule monitoring, opens the door to evaluate patients both off and on acid suppressive therapy. We should anticipate that researchers will apply this technique to study the patients considered treatment failures. This will hopefully guide us in selection of patients likely to benefit from high dose proton pump inhibitor therapy, versus those complicated GERD patients that we should consider for endoscopic or laparoscopic antireflux treatments. Lastly, prolonged Bravo pH monitoring on and off acid suppression may enlighten our understanding of the many patients with chest pain, asthma, hoarseness, often ascribed to acid reflux. Perhaps many of these patients suffer from non-acid reflux causes.

 

A prospective, randomized, double-blind placebo-controlled trial of enodscopic steroid injection therapy for recalcitrant esophageal peptic strictures.

Ramage JI, Rumalla A, Baron TH, Pochron NL, Zinsmeister AR, Murry JA, Norton ID, Diehl N, Romero Y
Am J Gastroenterology. 2005;100(11): 2419-2425.

Introduction

The recalcitrant peptic stricture was commonplace prior to the introduction of omperazole in 1989. Though potent acid suppression has decreased the prevalence of refractory peptic strictures, it still remains a challenging complication of GERD for the clinical gastroenterologist.

To examine utility of pre-dilation endoscopic corticosteroid injection to improve esophageal patency after esophageal TTS dilation reduces the need for repeat stricture dilation

Study Design
  • 30 pts with peptic stricture requiring ≥1 prior esophageal dilation.
  • Randomized to receive 0.5 cc/quadrant of triamcinolone (Kenalog 40 mg/cc) or sham injection into stricture.
  • Followed by through-the scope balloon dilation of the stricture. (Microvasive MaxForce TTS dilator, Waterton, MA).
  • Initial balloon size was selected according to estimate of stricture diameter and dilations held for 30-60 seconds and dilated up to 15-18 mm range.
  • Patients were stratified by number of prior dilation and stricture severity.
  • Post dilation all were placed on esomeprazole 40 mg twice daily.
  • Standardized telephone follow up questionnaires 1 wk 1, 3, 6, 9 and 12 months.
Results

Demographic characteristics to include age, gender, BMI, NSIAD use, presence of Barrett’s esophagus, and prior PPI use similar both groups. Two patients died of non esophageal causes. Four patients with persistent dysphagia had fundoplication, 2 in each group. Over one year of follow-up, two patients in the steroid group (13%) and nine in the sham group (60%) required repeat dilation p=0.011

Conclusions

This study illustrates that endoscopic injection of triamcinalone at the time of TTS dilation is beneficial in decreasing symptomatic peptic stricture relapse when pts are maintained on acid suppression with esomeprazole 40 mg bid.

This is the first controlled trial evaluating the utility of intra-stricture injection of steroids followed by maintenance PPI. These results indicate this technique improves patency of refractory peptic strictures – durable benefit is clear.

This study by the Mayo Clinic Group convincingly proves that endoscopic injection of steroids prior to peptic stricture dilation with TTS balloons is effective in decreasing relapse rates. The group studied only the most difficult peptic stricture patients, all failing prior dilation therapy.

The reviewer would mention one caveat of this study and one caution about this study. First, A caveat. All of the patients in both groups were maintained on esomeprazole 40 mg twice a day indefinitely to minimize recurrent acid reflux injury. It is very important to provide maximal acid suppression in these patients prone to stricture formation. Second, the reviewer would caution the clinical gastroenterologist from using this technique in patients with coexisting diabetes, scleroderma since steroids may promote supra-infection with Candida among diabetics and weakening fibrotic connective tissue among those with scleroderma.

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