Introduction: Endoluminal gastroplication (EndoCinch; Bard) has been introduced as an endoscopic treatment option in gastro-oesophageal reflux disease (GORD) patients with promising short term ...results. However, little is known about the long term efficacy of endoscopic suturing. The aim of this study was to evaluate prospectively the long term outcome after EndoCinch. Patients and methods: A total of 70 patients treated with EndoCinch at a single referral centre were studied prospectively. All patients were interviewed using a standardised questionnaire regarding their symptoms and medication prior to and 18 months after EndoCinch. In addition, follow up included endoscopy, 24 hour pH monitoring, and oesophageal manometry. Results: The procedure was well tolerated without major short or long term complications. Eighteen months after EndoCinch, 56/70 patients (80%) were considered treatment failures as their heartburn symptoms did not improve or proton pump inhibitor medication exceeded 50% of the initial dose. Endoscopy showed all sutures in situ in 12/70 (17%) patients while no remaining sutures could be detected in 18/70 (26%). In 54 and 50 patients examined, respectively, no significant changes in 24 hour pH monitoring (median pH <4/24 hours, 9.1% v 8.5%; p = 0.82) or lower oesophageal sphincter (LOS) pressure (7.7 v 10.3 mm Hg; p = 0.051) were observed while median LOS length slightly increased (3.0 to 3.2 cm; p<0.05). Conclusion: Endoscopic gastroplication (EndoCinch) is a safe and minimally invasive endoscopic treatment for GORD with reasonable short term results. In contrast, long term outcome is disappointing, probably due to suture loss in the majority of patients. Therefore, technical improvements to ensure suture durability are mandatory before endoscopic suturing can evolve as a therapeutic option for GORD treatment.
Summary
Background
As treatments for constipation become increasingly available, it is important to know when to progress along the treatment algorithm if the patient is not better.
Aim
To establish ...the definition of failure of a treatment to provide adequate relief (F‐PAR) to support this management and referral process in patients with chronic constipation.
Methods
We conducted an international Delphi Survey among gastroenterologists and general practitioners with a special interest in chronic constipation. An initial questionnaire based on recognised rating scales was developed following a focus group. Data were collected from two subsequent rounds of questionnaires completed by all authors. Likert scales were used to establish a consensus on a shorter list of more severe symptoms.
Results
The initial focus group yielded a first round questionnaire with 84 statements. There was good consensus on symptom severity and a clear severity response curve, allowing 67 of the symptom‐severity pairings to be eliminated. Subsequently, a clear consensus was established on further reduction to eight symptom statements in the final definition, condensed by the steering committee into five diagnostic statements (after replicate statements had been removed).
Conclusions
We present an international consensus on chronic constipation, of five symptoms and their severities, any of which would be sufficient to provide clinical evidence of treatment failure. We also provide data representing an expert calibration of commonly used rating scales, thus allowing results of clinical trials expressed in terms of those scales to be converted into estimates of rates of provision of adequate relief.
Background
Non‐adherence to medication is a challenging problem in daily clinical practice.
Objective
To assess reasons for non‐adherence in patients with chronic immune‐mediated inflammatory ...diseases (IMIDs) in a direct comparison including evaluation of treatment necessity and concerns.
Methods
ALIGN was a non‐interventional, multicountry, multicentre, self‐administered, cross‐sectional, epidemiologic survey study. Here, we investigate the German, Austrian and Swiss (DACH) cohort. Six hundred thirty‐one patients with different IMIDs (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis) under systemic therapies were evaluated concerning adherence, beliefs of necessity and concerns towards treatment in patients with IMIDs.
Results
The DACH cohort had significantly different levels of adherence depending on the IMID (P < 0.05) and the type of therapy (P < 0.05). Based on the significant influence of concerns on treatment adherence (P < 0.05) and the high belief of treatment necessity, patients could be classified in four attitudinal segments, which were unequally distributed throughout various IMIDs. High concerns had a significant influence on non‐adherence, whereas necessity did not. Older age, female sex, TNFi mono‐, conventional combination and TNFi combination therapy are positively associated with adherence.
Conclusions
In the DACH region, patients are less concerned about medication and believe in the necessity of treatment. Therefore, we suggest adapting the communication in the various patient groups.
Chemotherapy with gemcitabine has been shown to be an effective regimen in advanced or metastatic pancreatic cancer with improvement of both quality of life and survival time. The response of the ...tumour marker CA 19-9 to chemotherapy with gemcitabine was studied in order to find out whether it is related to survival time of patients. Forty-three consecutive patients (median age 61 years, range 39-76 years; 20 males, 23 females) suffering from histologically proven locally advanced or metastatic pancreatic adenocarcinoma and a baseline Karnofsky-index > or = 60 were treated with gemcitabine in a dose of 1,000 mg/m(-2) weekly x 7 followed by 1 week of rest during the first cycle and thereafter 1,000 mg/m(-2) weekly x 3 followed by 1 week of rest until progression. In 36 of 43 patients serial measurements of CA 19-9 could be performed. Patients with a decrease of > 20% of the baseline CA 19-9 level after 8 weeks of treatment (n = 25) had a significantly better median survival than patients with a rise or a decrease < or = 20% (n = 11) (268 vs 110 days; P < 0.001). The response of CA 19-9 was the strongest independent predictor of survival (P < 0.001) in the multivariate analysis. In conclusion, a decrease of CA 19-9 > 20% during the first weeks of chemotherapy with gemcitabine is associated with a better survival of patients with locally advanced or metastatic pancreatic cancer. Serial measurements of CA 19-9 are useful to decide whether further chemotherapy after the first weeks of treatment is indicated.
Background
The full-thickness Plicator
®
(Ethicon Endosurgery, Sommerville, NJ, USA) was developed for endoscopic treatment of gastroesophageal reflux disease (GERD). The goal is to restructure the ...antireflux barrier by delivering transmural pledgeted sutures through the gastric cardia. To date, studies using this device have involved the placement of a single suture to create the plication. The purpose of this study was to evaluate the 12-month safety and efficacy of this procedure using multiple implants to restructure the gastroesophageal (GE) junction.
Methods
A multicenter, prospective, open-label trial was conducted at four tertiary centers. Eligibility criteria included symptomatic GERD GERD Health-Related Quality-of-Life (GERD-HRQL) questionnaire, off of medication, and pathologic reflux (abnormal 24-h pH) requiring daily proton pump inhibitor therapy. Patients with Barrett’s epithelium, esophageal dysmotility, hiatal hernia >3 cm, and esophagitis (grade III or greater) were excluded. All patients underwent endoscopic full-thickness plication with linear placement of at least two transmural pledgeted sutures in the anterior gastric cardia.
Results
Forty-one patients were treated. Twelve months post treatment, 74% of patients demonstrated improvement in GERD-HRQL scores by ≥50%, with mean decrease of 17.6 points compared with baseline (7.8 vs. 25.4,
p
< 0.001). Using an intention-to-treat model, 63% of patients had symptomatic improvements of ≥50%, with mean GERD-HRQL decrease of 15.0 (11.0 vs. 26.0,
p
< 0.001). The need for daily proton pump inhibitor (PPI) therapy was eliminated in 69% of patients at 12 months on a per-protocol basis, and 59% on an intention-to-treat basis. Adverse events included postprocedure abdominal pain (44%), shoulder pain (24%), and chest pain (17%). No long-term adverse events occurred.
Conclusions
Endoscopic full-thickness plication using multiple Plicator implants can be used safely and effectively to improve GERD symptoms and reduce medication use.
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