The International Study Group of Pancreatic Surgery definition of delayed gastric emptying and the effects of various surgical modifications on the occurrence of delayed gastric emptying after pancreatoduodenectomy.

BACKGROUND: A number of definitions have been used for delayed gastric emptying (DGE) after pancreatoduodenectomy and the reported rates varied widely. The International Study Group of Pancreatic Surgery (ISGPS) definition is the current standard but it is not used universally. In this comprehensive review, we aimed to determine the acceptance rate of ISGPS definition of DGE, the incidence of DGE after pancreatoduodenectomy and the effect of various technical modifications on its incidence. DATA SOURCE: We searched PubMed for studies regarding DGE after pancreatoduodenectomy that were published from 1 January 1980 to 1 July 2015 and extracted data on DGE definition, DGE rates and comparison of DGE rates among different technical modifications from all of the relevant articles. RESULTS: Out of 435 search results, 178 were selected for data extraction. The ISGPS definition was used in 80% of the studies published since 2010 and the average rates of DGE and clinically relevant DGE were 27.7% (range: 0-100%; median: 18.7%) and 14.3% (range: 1.8%-58.2%; median: 13.6%), respectively. Pylorus preservation or retrocolic reconstruction were not associated with increased DGE rates. Although pyloric dilatation, Braun's entero-enterostomy and Billroth II reconstruction were associated with significantly lower DGE rates, pyloric ring resection appears to be most promising with favorable results in 7 out of 10 studies. CONCLUSIONS: ISGPS definition of DGE has been used in majority of studies published after 2010. Clinically relevant DGE rates remain high at 14.3% despite a number of proposed surgical modifications. Pyloric ring resection seems to offer the most promising solution to reduce the occurrence of DGE.

[Gastroparesis. Definition, diagnostics, and therapy]. / Gastroparese : Definition, Diagnostik und Therapie.

Gastroparesis is characterized by a constellation of upper gastrointestinal symptoms in association with delayed gastric emptying in the absence of mechanical outlet obstruction from the stomach. Major symptoms are nausea, vomiting, early satiety or postprandial fullness, bloating, and abdominal or epigastric pain. Idiopathic, diabetic, and postsurgical causes represent the most common etiologies. Diagnostic procedures for the evaluation of gastroparesis comprise gastric emptying scintigraphy (gold standard), (13)C-octanoate breath testing, and a wireless motility capsule. Management of gastroparesis includes normalization of nutritional state, relief of symptoms, glycemic control, and improvement of gastric emptying. Medical treatment entails use of prokinetic drugs, which are currently the first-line therapy. Nausea and vomiting might be positively influenced by antiemetic drugs. Gastric electronic stimulation and surgical interventions should be used in well-defined patients and represent a therapeutic option in tertiary centers.

Moving towards the New International Study Group for Pancreatic Surgery (ISGPS) definitions in pancreaticoduodenectomy: a comparison between the old and new.

BACKGROUND: The International Study Group for Pancreatic Surgery (ISGPS) has proposed several definitions for postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE) and post-pancreatectomy haemorrhage (PPH). We assessed the effects of implementing these definitions on predicting outcomes. METHODS: A database of 77 patients who underwent pancreaticoduodenectomy between January 2005 and December 2009 was analysed. Morbidities were defined and classified using the ISGPS definitions and recalculated based on the definitions adopted by our institution ('Old' definitions) prior to the implementation of ISGPS definitions. Data for the two groups were then compared. RESULTS: The morbidity rate rose to 70.1% from 27.2% when ISGPS rather than Old definitions were used to define morbidities (P < 0.001). Incidences of DGE, POPF and PPH were 20.7%, 39.0% and 10.4%, respectively. Rates of DGE and POPF were significantly higher according to ISGPS definitions than to Old definitions (20.7% vs. 5.2% [P= 0.001] and 39.0% vs. 15.6% [P= 0.004], respectively). According to the ISGPS definitions, all of the 12 additional patients with DGE and 12 of the 18 additional patients with POPF had grade A morbidities. Patients with ISGPS-defined morbidity had a longer intensive care unit (ICU) stay, longer postoperative stay and longer total stay (P= 0.030, P= 0.007 and P= 0.001, respectively). CONCLUSIONS: The morbidity rate more than doubled when ISGPS definitions were applied (an additional 42.9% of patients demonstrated morbidities). The majority of patients with DGE and POPF had grade A morbidities. The ISGPS definitions correlate well with ICU stay, postoperative stay and total length of stay.

Delayed gastric emptying after pylorus-preserving pancreaticoduodenectomy: validation of International Study Group of Pancreatic Surgery classification and analysis of risk factors.

OBJECTIVES: This study evaluates the incidence and clinical features and associated risk factors of delayed gastric emptying (DGE) after pancreaticoduodenectomy, employing the International Study Group of Pancreatic Surgery (ISGPS) consensus definition. METHODS: Demographic, pathological and surgical details for 260 consecutive patients who underwent pylorus-preserving pancreaticoduodenectomy at a single institution were analysed using univariate and multivariate models. RESULTS: Postoperative complications occurred in 108 (41.5%) and DGE was diagnosed in 36 (13.8%) of 260 patients. Among the 36 DGE patients, 16 had grade A, 18 grade B and two grade C DGE. Resumption of a solid diet (P < 0.001), time to passage of stool (P= 0.002) and hospital discharge (P < 0.001) occurred later in DGE patients. The need for total parenteral nutrition was significantly higher in DGE grade B/C patients (P < 0.001). In the univariate analysis, abdominal collections (P≤ 0.001), pancreatic fistula (PF) grades B and C (P < 0.001), biliary fistula (P= 0.002), pulmonary complications (P < 0.001) and sepsis (P= 0.002) were associated with DGE. Only abdominal collections (P= 0.009), PF grade B/C (P < 0.001) and sepsis (P= 0.024) were associated with clinically relevant DGE. In the multivariate analysis, PF grade B/C (P= 0.004) and biliary fistula (P= 0.039) were independent risk factors for DGE. CONCLUSIONS: The ISGPS classification and grading systems correlate well with the clinical course of DGE and are feasible for patient management. The principal risk factors for DGE seem to be pancreatic and biliary fistulas.

What are the important subsets of gastroparesis?

Gastroparesis is often divided into subsets based on etiology and pathophysiology; however, the utility of these subsets in the diagnosis and treatment of gastro-paresis is not well defined. The objectives are to consider the subsets of gastroparesis from the perspectives of etiology and pathogenesis, pathophysiology, histopathology, and clinical associations, with particular focus on similarities and differences between diabetic and idiopathic gastroparesis and consideration of the potential subset of painful gastroparesis. We conclude that idiopathic and diabetic gastroparesis has similar initial presentations and manifestations, except that idiopathic gastroparesis tends to be associated more frequently with pain. Myopathic disorders are uncommon. Extrinsic denervation was considered the most common etiology; however, with the decline in surgery for peptic ulceration and in-depth study of full-thickness gastric biopsies, the most common intrinsic defects are being recognized in the interstitial cells of Cajal (ICC-opathy) and with immune infiltration and neuronal changes (intrinsic neuropathic gastroparesis). Histomorphological differences at the microscopic level between diabetic and idiopathic gastroparesis are still of unclear significance. Two gastroparesis subsets worthy of special mention, because they are potentially reversible with identification of the cause, are postviral gastroparesis, which has a generally good prognosis, and iatrogenic gastroparesis, especially in patients with non-surgical gastroparesis, such as diabetics exposed to incretins such as pramlintide and exenatide.

A novel classification scheme for gastroparesis based on predominant-symptom presentation.

AIM: Symptoms of gastroparesis are very diverse. Classifying patients by predominant symptom may improve management strategy. GOAL: To validate a new symptom-predominant classification for gastroparesis using symptom severity and quality-of-life measures. STUDY: Subjects with gastroparesis for >2 months were prospectively enrolled. A physician classified each subject into one of the following: vomiting-predominant, dyspepsia-predominant, or regurgitation-predominant gastroparesis. Subjects also classified themselves independently from the physician. Each subject completed a Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) and SF-12v2 Health-Related Quality-Of-Life survey. Receiver operating characteristic curves were constructed with sensitivity and specificity of each PAGI-SYM subscale to differentiate subjects into symptom-predominant subgroups. Area under the curve (AUC) was used to compare the receiver operating characteristic curves. Analysis of variance, Cohen's kappa (kappa) statistic, student t test, and Pearson correlation (r) were used. RESULTS: One hundred subjects (87 females, mean 48 y) were enrolled. There was a 78% concordance between physician and subject's classification of gastroparesis with substantial correlation (kappa=0.64). PAGI-SYM nausea/vomiting subscale (AUC=0.79) and PAGI-SYM heartburn/regurgitation subscale (AUC=0.73) were the best in differentiating subjects into vomiting-predominant and regurgitation-predominant gastroparesis, respectively. No subscale was adequate to differentiate dyspepsia-predominant gastroparesis. SF-12v2 total scores significantly correlated with worsening of the total PAGI-SYM scores (r=-0.339 to -0.600, all P<0.001). CONCLUSIONS: There was a substantial agreement between physician and patient using a symptom-predominant gastroparesis classification. Results suggest that a predominant-symptom classification is a valid means to categorize subjects with vomiting-predominant and regurgitation-predominant gastroparesis. Patients with dyspepsia and delayed gastric emptying need further research.

Gastrointestinal complications of diabetes.

Gastrointestinal complications of diabetes include gastroparesis, intestinal enteropathy (which can cause diarrhea, constipation, and fecal incontinence), and nonalcoholic fatty liver disease. Patients with gastroparesis may present with early satiety, nausea, vomiting, bloating, postprandial fullness, or upper abdominal pain. The diagnosis of diabetic gastroparesis is made when other causes are excluded and postprandial gastric stasis is confirmed by gastric emptying scintigraphy. Whenever possible, patients should discontinue medications that exacerbate gastric dysmotility; control blood glucose levels; increase the liquid content of their diet; eat smaller meals more often; discontinue the use of tobacco products; and reduce the intake of insoluble dietary fiber, foods high in fat, and alcohol. Prokinetic agents (e.g., metoclopramide, erythromycin) may be helpful in controlling symptoms of gastroparesis. Treatment of diabetes-related constipation and diarrhea is aimed at supportive measures and symptom control. Nonalcoholic fatty liver disease is common in persons who are obese and who have diabetes. In persons with diabetes who have elevated hepatic transaminase levels, it is important to search for other causes of liver disease, including hepatitis and hemochromatosis. Gradual weight loss, control of blood glucose levels, and use of medications (e.g., pioglitazone, metformin) may normalize hepatic transaminase levels, but the clinical benefit of aggressively treating nonalcoholic fatty liver disease is unknown. Controlling blood glucose levels is important for managing most gastrointestinal complications.

American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis.

This literature review and the recommendations herein were prepared for the American Gastroenterological Association Clinical Practice Committee. The paper was approved by the Committee on May 16, 2004, and by the AGA Governing Board on September 23, 2004.

Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders.

OBJECTIVE: Describe the development and evaluation of a new self-report instrument, the patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) in subjects with gastroesophageal reflux disease (GERD), dyspepsia, or gastroparesis. METHODS: Recruited subjects with GERD (n=810), dyspepsia (n = 767), or gastroparesis (n = 169) from the US, France, Germany, Italy, the Netherlands, and Poland. Subjects completed the PAGI-SYM, SF-36, a disease-specific HRQL measure (PAGI-QOL), and disability day questions. Two-week reproducibility was evaluated in 277 stable subjects. We evaluated construct validity by correlating subscale scores with SF-36, PAGI-QOL, disability days, and global symptom severity scores. RESULTS: The final 20-item PAGI-SYM has six subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Internal consistency reliability was good (alpha = 0.79-0.91); test-retest reliability was acceptable (Intraclass correlation coefficients alpha=0.60-0.82). PAGI-SYM subscale scores correlated significantly with SF-36 scores (all p < 0.0001), PAGI-QOL scores (all p < 0.0001), disability days (p < 0.0001), and global symptom severity (p < 0.0001). Mean PAGI-SYM scores varied significantly in groups defined by disability days (all p < 0.0001), where greater symptom severity was associated with more disability days. CONCLUSIONS: Results suggest the PAGI-SYM, a brief symptom severity instrument, has good reliability and evidence supporting construct validity in subjects with GERD, dyspepsia, or gastroparesis.

Cross-cultural development and validation of a patient self-administered questionnaire to assess quality of life in upper gastrointestinal disorders: the PAGI-QOL.

OBJECTIVE: Summarize the Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QOL) development and provide results on its reliability and validity from the international psychometric validation in dyspepsia, GastroEsophageal Reflux Disease (GERD), and gastroparesis. METHODS: Subjects completed the pilot PAGI-QOL at baseline and 8 weeks; and a subsample also at 2 weeks. Other assessments were: Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index, SF-36, number of disability days. RESULTS: 1736 patients completed the PAGI-QOL at baseline. The questionnaire was reduced, producing a 30-item final version covering five domains: Daily Activities, Clothing, Diet and Food Habits, Relationship (REL), and Psychological Well-Being and Distress. Internal consistency was excellent (Cronbach's alpha range: 0.83-0.96). Test-retest reproducibility was good: intraclass correlations coefficients were over 0.70 except for the REL scale (0.61). Concurrent validity between the PAGI-QOL total score and all SF-36 subscale scores was good with moderate (0.52) to strong (0.72) correlations. PAGI-QOL scores showed excellent discriminant properties: patients who had spent some days in bed, had missed some days at work, and were kept from usual activities had much lower PAGI-QOL scores than those who did not (p < 0.0001). CONCLUSION: The PAGI-QOL is a valid and reliable instrument assessing quality of life in patients with dyspepsia, GERD, or gastroparesis.

Gastroparesis Cardinal Symptom Index (GCSI): development and validation of a patient reported assessment of severity of gastroparesis symptoms.

BACKGROUND: Patient-rated symptom assessments are needed for evaluating the effectiveness of medical treatments and for monitoring outcomes in gastroparesis. OBJECTIVE: This paper summarizes the development and psychometric evaluation of a new instrument, the Gastroparesis Cardinal Symptom Index (GCSI), for assessing severity of symptoms associated with gastroparesis. METHODS: The GCSI was based on reviews of the medical literature, patient focus groups, and interviews with clinicians. A sample of 169 patients with a documented diagnosis of gastroparesis participated in the psychometric evaluation study. Patients completed the GCSI, the SF-36 Health Survey, and disability days questions at baseline and after 8 weeks. A randomly selected sub-sample of 30 subjects returned at 2 weeks to assess test retest reliability. Clinicians rated severity of symptoms, and both clinicians and patients rated change in gastroparesis-related symptoms over the 8 week study. RESULTS: The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). Internal consistency reliability was 0.84 for the GCSI total score and ranged from 0.83 to 0.85 for the subscale scores. Two week test retest reliability was 0.76 for the total score and ranged from 0.68 to 0.81 for subscale scores. Construct validity was supported, given that we observed significant relationships between clinician assessed symptom severity and GCSI total score, significant differences between gastroparesis and dyspepsia patients (n = 760) on GCSI total (p < 0.0001) and subscale scores (p < 0.03 to p < 0.0001), moderate and significant relationships between GCSI total and SF-36 scores, and significant associations between GCSI total score and reports of restricted activity and bed disability days. Patients with greater symptom severity, as rated by clinicians, reported more symptom severity on GCSI total score. GSCI total scores were responsive to changes in overall gastroparesis symptoms as assessed by clinicians (p < 0.0001) and patients (p = 0.0004). CONCLUSION: The findings of this study indicate that the GCSI is a reliable and valid instrument for measuring symptom severity in patients with gastroparesis.

Gastroparesia y dispepsia funcional: diagnóstico y tratamiento / Gastroparesis and functional dyspepsia: diagnosis and treatment

Gastroparesis corresponds to the clinical picture of a non-obstructive alteration in gastric emptying. The most common causes are idiopathic, postsurgical and diabetes mellitus. Endoscopy and gastric emptying scintigraphy are necessary for diagnosis. Fractionating the diet and avoiding fat are recommended actions. Prokinetics are fundamental in gastroparesis therapy. Domperidone is the first choice because it has a better safety profile. It is advisable to rotate prokinetics. In refractory cases it is suggested to try other prokinetics (such as erythromycin or prucalopride), effective management of nausea and nutrition optimization. In selected cases, therapies such as electrical stimulation could be evaluated. Functional dyspepsia is defined as symptoms that probably originate in the gastroduodenal region, having ruled out other possibilities. Therefore, endoscopy should show no alterations that could explain the symptoms. The most frequently encountered pathophysiological alterations are slow gastric emptying, impaired accommodation and hypersensitivity. None has been linked unequivocally to a pattern of symptoms. It is suggested to start with proton-pump inhibitors therapy. In refractory cases, prokinetics should be added. If there is no adequate response, 24-hour pH monitoring and gastric emptying should be ordered. In case of altered gastric emptying, adjust prokinetics. If gastric emptying is normal, bupirone or mianserin could be used.

La gastroparesia corresponde a un cuadro clínico debido a mal vaciamiento gástrico no obstructivo del estómago. Sus causas más frecuentes son idiopática, diabetes mellitus y postquirúrgica. La endoscopia y el cintigrama de vaciamiento gástrico son necesarios para el diagnóstico. Se recomienda fraccionar la dieta y evitar las grasas. Los procinéticos son fundamentales en el tratamiento de la gastroparesia. La domperidona es la primera opción por su mejor perfil de seguridad. Es aconsejable rotar los procinéticos. En casos refractarios se puede intentar otros procinéticos (como eritromicina o prucalopride), manejar específicamente las náuseas y optimizar la nutrición. En casos seleccionados se puede intentar terapias como estimulación eléctrica. La dispepsia funcional está definida por síntomas que probablemente se originan en la región gastroduodenal, habiendo descartado otras posibilidades. Por esto, requiere un estudio endoscópico sin alteraciones que expliquen los síntomas. Los hallazgos fisiopatológicos más frecuentemente encontrados son alteraciones del vaciamiento gástrico, trastornos de la acomodación e hipersensibilidad. Ninguno de ellos ha sido asociado inequívocamente a algún patrón de síntomas. Se sugiere iniciar tratamiento con inhibidores de la bomba de protones. En casos refractarios, es aconsejable agregar procinéticos. Si no hay adecuada respuesta, se sugiere estudiar con una ph-metría de 24 horas y vaciamiento gástrico. En caso de vaciamiento alterado, ajustar los procinéticos. En caso de vaciamiento normal, se sugiere uso de buspirona o mianserina.