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Background The aim of this study was to clarify the pathophysiology of functional dyspepsia (FD), a highly prevalent gastrointestinal syndrome, and its relationship with the better-understood syndrome of gastroparesis. Methods Adult patients with chronic upper gastrointestinal symptoms were followed up prospectively for 48 weeks in multi-center registry studies. Patients were classified as having gastroparesis if gastric emptying was delayed; if not, they were labeled as having FD if they met Rome III criteria. Study analysis was conducted using analysis of covariance and regression models. Results Of 944 patients enrolled during a 12-year period, 720 (76%) were in the gastroparesis group and 224 (24%) in the FD group. Baseline clinical characteristics and severity of upper gastrointestinal symptoms were highly similar. The 48-week clinical outcome was also similar but at this time 42% of patients with an initial diagnosis of gastroparesis were reclassified as FD based on gastric-emptying results at this time point; conversely, 37% of patients with FD were reclassified as having gastroparesis. Change in either direction was not associated with any difference in symptom severity changes. Full-thickness biopsies of the stomach showed loss of interstitial cells of Cajal and CD206+ macrophages in both groups compared with obese controls. Conclusions A year after initial classification, patients with FD and gastroparesis, as seen in tertiary referral centers at least, are not distinguishable based on clinical and pathologic features or based on assessment of gastric emptying. Gastric-emptying results are labile and do not reliably capture the pathophysiology of clinical symptoms in either condition. FD and gastroparesis are unified by characteristic pathologic features and should be considered as part of the same spectrum of truly "organic" gastric neuromuscular disorders. ClinicalTrials.gov Identifier NCT00398801, NCT01696747

Background and Aims Diagnosis of GI neuromuscular diseases is mostly on the basis of symptomatology and is often unreliable. Pathologic analysis of affected tissue (eg, the myenteric plexus and muscle) is a potentially valuable method for both diagnosis and advancement of our knowledge about the biologic basis for these syndromes. However, until now access to the deeper layers of the GI tract has been limited, generally requiring invasive surgical techniques. Methods We report a “close-then-resect” endoscopic full-thickness biopsy sampling (EFTB) technique using an over-the-scope clip and telescope for rectal muscle biopsy sampling in patients with suspected severe neuromuscular gut disorders. The main outcome measures were technical success and adverse events. Results Thirteen patients (11 women; mean age 27 ± 5.4 years) with diffusely delayed colonic transit underwent EFTB. The mean (± standard deviation) procedure time was 30 ± 5.2 minutes. The mean size of the resected specimen was 18 ± 3.5 mm. Histologic full-thickness tissue samples were achieved for all patients. Postprocedural adverse events were reported in 2 patients, and both were graded as mild (1 self-limited bleeding and 1 with rectal pain). Hematoxylin and eosin staining of tissue samples confirmed adequate cross-sectional imaging of muscularis propria in all patients with excellent demonstration of the myenteric plexus and both layers of muscle. Two patients demonstrated a decrease in interstitial cells of Cajal as demonstrated by CD117 staining. No cases demonstrated appreciable inflammation involving myenteric ganglia. Conclusions Diagnostic EFTB with modified over-the-scope clip for the close-then-resect method appears to be a safe and effective technique to obtain adequate full-thickness rectal specimens, allowing for both quantitative and qualitative analysis for the diagnosis of neuromuscular GI dysmotility.