Management of people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care is noninferior to management in a specialized outpatient clinic: a randomized, noninferiority trial.

AIM: To evaluate whether management of people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care has noninferior HbA1c outcomes compared with mono-sectorial management in a specialized outpatient clinic. METHODS: A randomized controlled, noninferiority study. People with moderate hyperglycaemia, hypertension and/or incipient complications were eligible for the study. All participants had annual comprehensive check-ups at the outpatient clinic. Quarterly check-ups were conducted by general practitioners (GPs) for the shared care group and by endocrinologists at the outpatient clinic for the control group. The primary outcome was the mean difference in HbA1c from baseline to 12 months of follow-up. The noninferiority margin for HbA1c was 4.4 mmol/mol. RESULTS: A total of 140 people were randomized [age 65.0 ± 0.9 years, HbA1c 52 ± 0.8 mmol/mol (6.9 ± 0.1%), systolic BP 135.6 ± 1.1 mmHg; all mean ± sem]. Peripheral neuropathy was present in 68% of participants and microalbuminuria in 19%; 15% had history of a previous major cardiovascular event. Among study completers (n = 133), HbA1c increased by 2.3 mmol/mol (0.2%) in the shared care group and by 1.0 mmol/mol (0.1%) in the control group, with a between-group difference of 1.3 mmol/mol [90% confidence interval (CI) -1.3, 3.9] (0.1%, 90% CI -0.1, 0.4). Noninferiority was confirmed in both per protocol and intention to treat analyses. CONCLUSION: We found that our shared care programme was noninferior to specialized outpatient management in maintaining glycaemic control in this group of people with Type 2 diabetes. Shared care should be considered for the future diabetes management of Type 2 diabetes.

Quantitative hepatobiliary scintigraphy and endoscopic sphincter of Oddi manometry in patients with suspected sphincter of Oddi dysfunction: assessment of flow-pressure relationship in the biliary tract.

OBJECTIVE: In the present study, the diagnostic efficacy of quantitative hepatobiliary scintigraphy (QHBS) was compared with that of endoscopic sphincter of Oddi (SO) manometry (ESOM) in patients with a suspected SO dysfunction (SOD) of biliary type II or III. METHODS: Twenty cholecystectomized patients with SOD biliary types II and III were investigated by QHBS and by ESOM. Twenty asymptomatic cholecystectomized patients served as controls for scintigraphy. ESOM was performed by applying the station pull-through method. Then SO basal pressure and phasic contraction characteristics were determined. During QHBS, time-activity curves were generated, and the time-to-peak (Tmax), the half-time of excretion (T(1/2)), the duodenal appearance time (DAT) and the hilum-to-duodenum transit time (HDTT) were then calculated. At the 60th minute of QHBS, 5 ng/kg body weight/min caerulein was administered. RESULTS: In patients with SOD and elevated SO basal pressure (> 40 mmHg), QHBS parameters, such as Tmax and T(1/2) calculated from regions of interest over the hepatic hilum and common bile duct, HDTT and DAT proved to be significantly increased compared to controls: 28.7 +/- 4.3 versus 21.1 +/- 4.6 min, 39.7 +/- 15.4 versus 18.8 +/- 2.6 min, 9.0 +/- 3.6 versus 2.3 +/- 1.3 min and 27.1 +/- 4.9 versus 16.6 +/- 3.0 min, respectively. In contrast, in patients with SOD and normal SO basal pressure, QHBS parameters did not differ significantly from the controls. For the pooled data on the symptomatic patients with SOD, a statistically significant linear correlation was found between the SO basal pressure and the QHBS parameters. Although HDTT was the most sensitive scintigraphic parameter (89%), the combined sensitivity and specificity of Tmax and T(1/2) of the common bile duct reached 100%. No scintigraphic sign of a paradoxical response to cholecystokinin was detected. CONCLUSIONS: QHBS is a useful non-invasive diagnostic method for the selection of SOD patients with an elevated SO basal pressure. A significant correlation has been established between the trans-papillary bile flow measured by QHBS and the SO basal pressure determined by ESOM.

Video manometry of the sphincter of Oddi: a new aid for interpreting manometric tracings and excluding manometric artefacts.

BACKGROUND AND STUDY AIMS: Endoscopic sphincter of Oddi manometry (ESOM) allows direct assessment of motor function in the sphincter of Oddi. However, variations in examination conditions and duodenal motility may have a critical effect on the results of ESOM. The aim of the present study was to develop a new method sphincter of Oddi video manometry-based on simultaneous ESOM and real-time endoscopic image analysis, and to investigate the usefulness of video manometry for detecting manometric artefacts during ESOM. PATIENTS AND METHODS: Seven consecutive patients who had undergone cholecystectomy and were referred with a suspicion of sphincter of Oddi dysfunction were investigated. Sphincter of Oddi pressure and endoscopic images (20 frames/s) were recorded simultaneously on a Synectics PC Polygraf computer system with a time-correlated basis, and then compared. RESULTS: On ESOM, 69 sphincter of Oddi phasic contractions were identified, with an average amplitude of 153.9+/-85.0 mm Hg and a duration of 7.9+/-1.2 seconds. Visual analysis of the real-time endoscopic images, replayed in cine loop by the computer, revealed 236 separate duodenal contractions, with an average frequency of 3.5+/-2.4/min (range: 1-12/min). On the ESOM tracing, 78% of the duodenal contractions had a corresponding pressure wave with an average duration of 2.8+/-0.4 seconds and an amplitude of 71.9+/-16.7 mm Hg. Other artefacts on the ESOM tracings, such as catheter movements, pseudocontractions, hyperventilation, or retching, were also easily recognized using simultaneous ESOM and real-time endoscopic image analysis. CONCLUSIONS: Video manometry of the sphincter of Oddi is a promising new method for improving the analysis and documentation of ESOM tracings. It has several advantages over the conventional technique, allowing visual detection of duodenal activity and enabling enhanced recognition of other manometric artefacts.

Comparison of the dynamics of bile emptying by quantitative hepatobiliary scintigraphy before and after cholecystectomy in patients with uncomplicated gallstone disease.

PURPOSE: Quantitative hepatobiliary scintigraphy, a noninvasive method frequently used to diagnose several biliary tract disorders, shows abnormalities in bile secretion and outflow. It is well known that there are wide variations in the normal pattern of bile emptying, but the effect of cholecystectomy on the bile flow has not yet been investigated. The goal of the current study was to examine the dynamics and normal variations of bile flow by quantitative hepatobiliary scintigraphy before and after cholecystectomy in a group of patients with uncomplicated gallstone disease. METHODS: Twenty patients were evaluated before and after cholecystectomy through cholecystokinin octapeptide-augmented quantitative hepatobiliary scintigraphy, and quantitative parameters of bile emptying (Tmax: time to peak activity, T1/2: half-emptying time before and after cholecystokinin octapeptide and duodenum appearance time) were determined and then compared. RESULTS: Before operation, the bile outflow displayed wide variations, with a moderately delayed common bile duct emptying time in some patients. After cholecystectomy, the T1/2 of the common bile duct decreased significantly when compared with the preoperative status, with only minor patient-to-patient variation, indicating uniformly faster bile emptying (common bile duct T1/2 before and after operation: 30.5 +/- 14.8 and 18.8 +/- 2.6 min, respectively). Cholecystokinin octapeptide administration caused rapid bile outflow from the common bile duct, with a significant decrease in the T1/2 parameters before and after cholecystectomy. CONCLUSIONS: In patients with their gallbladders in situ, the bile emptying rate showed wide variations and may be moderately slow without distal common bile duct obstruction. After cholecystectomy, the rate of bile emptying accelerated and showed only minor variations, thereby increasing the sensitivity of quantitative hepatobiliary scintigraphy for showing partial biliary obstruction.

Sphincter of Oddi manometry before and after laparoscopic cholecystectomy.

BACKGROUND AND STUDY AIMS: In animal studies cholecystectomy has been found to alter the normal effect of cholecystokinin (CCK) on sphincter of Oddi (SO) function. This could be of importance with regard to the development of postcholecystectomy biliary pain. We therefore investigated the effect of laparoscopic cholecystectomy on SO motility before and after infusion with CCK. PATIENTS AND METHODS: A prospective study of SO motility, under basal conditions and during CCK (ceruletide) infusion, was carried out in eight women with uncomplicated gallstone disease, before and after laparoscopic cholecystectomy. RESULTS: Laparoscopic cholecystectomy increased common bile duct pressure (P = 0.01) and decreased the frequency of phasic contractions (P=0.05). However, the inhibitory effect of CCK was preserved as infusion of CCK was associated with a significant reduction in SO phasic amplitude and frequency, both before and after cholecystectomy. CONCLUSIONS: Following laparoscopic cholecystectomy an indisputable inhibitory effect of CCK in the SO was found. Common bile duct pressure increased and minor modifications in basal SO motility were seen.

Pain patterns after distension of the gallbladder in patients with acute cholecystitis.

BACKGROUND: Visceral pain is characterized by poor pain localization and a referred or radiating pain pattern. Its clinical importance in the abdomen is stressed by the finding that about one-third of patients still complain of abdominal pain after cholecystectomy. A better understanding of symptoms arising from the gallbladder and the underlying pathophysiology is therefore desirable. The aim of the present study was consequently primarily to characterize the symptom patterns after distension of the gallbladder. Secondary aims were to describe the pressure-volume relation in the gallbladder and the cystic duct opening pressure. METHODS: Twelve patients (nine women, three men) treated with cholecystostomy for acute cholecystitis were investigated. Simultaneous cholescintigraphy and measurement of changes in intraluminal gallbladder pressure after injections of saline through a gallbladder catheter were performed. After each injection of saline the localization of pain and the presence of nausea and vomiting were registered. The injections continued until the patient felt abdominal pain necessitating cessation of the investigation or until the cystic duct opened (visualized on cholescintigraphy). RESULTS: Distension of the gallbladder caused pain in 10 of the 12 patients. In 70% the pain was localized under the right costal margin or in the epigastrium. No mathematical formula could describe the pressure-volume relation in the gallbladder. The cystic duct opening pressure varied between 3 and 44 mmHg. CONCLUSIONS: Pain caused by increased gallbladder pressure is localized mostly, but not always, under the right curvature and in the epigastrium. A substantial variation in cystic duct opening pressure was found.

Pain and dyspepsia after elective and acute cholecystectomy.

BACKGROUND: Postcholecystectomy pain occurs in 20-30%. The main cause of this pain remains unclear. Whether the underlying gallbladder disease influences the outcome after cholecystectomy is not fully established. METHODS: A multicenter questionnaire study comparing the occurrence of abdominal pain and dyspepsia 5-10 years after cholecystectomy in 345 (222 women, 123 men) patients cholecystectomized for acute cholecystitis and in a control group of 296 (213 women, 83 men) patients cholecystectomized for uncomplicated symptomatic gallbladder stones. RESULTS: Of 641 questionnaires, 534 (83%) were completed. Complaints of abdominal pain and dyspepsia were found with similar frequencies in the acute cholecystitis and gallstone groups. Women had abdominal pain more often than men (42% versus 29%) (P = 0.01). Although more than one-third complained of abdominal pain after cholecystectomy, 93% had improved or were cured. CONCLUSION: The outcome after cholecystectomy seems to be independent of the underlying gallbladder disease (acute cholecystitis or elective operations for gallstones).

[Uncomplicated gallstones: who should be operated on?]. / Ukomplicerede galdeblaeresten: Hvem skal opereres?

Gallstones are common and occur asymptomatically or symptomatically with or without complications. Treatment is only required for symptomatic gallstones and complications in gallstones. Laparoscopic cholecystectomy is the treatment of choice for symptomatic gallstones and is performed with an increasing frequency. One may fear, that the indications for cholecystectomy have changed, and surgery is now undertaken for a lesser degree of morbidity. Cholecystectomy does not increase life expectancy, and 20-30% of patients cholecystectomized for symptomatic gallstones complain of abdominal pain of unknown origin after the operation. New valid parameters in order to predict which patients will benefit from cholecystectomy are therefore necessary. Symptoms specific to gallstones are not precisely known, and greatest success in treatment seems to be related to the occurrence of severe, often steady pain, of hours' duration, often located in the epigastrium or upper right quadrant, with or without radiation and/or vomiting. Dyspepsia alone is not an indication for cholecystectomy. Psychological vulnerability may predict a poor outcome after cholecystectomy and should lead to reconsideration of the indication for surgery.

[Laparoscopic fundoplication in gastroesophageal reflux]. / Laparoskopisk fundoplikation ved gastroøsofageal refluks.

Gastro-oesophageal reflux disease (GORD) is a chronic disorder requiring lifelong medical therapy or surgery. In the present study we evaluated the postoperative course and effect of laparoscopic fundoplication on GORD in 27 patients with a median age of 44 (range 27-73) years. Fifteen were operated on with a Watson procedure, and 12 patients had a Nissen procedure. Median stay and convalescence after surgery was one and 10 days respectively. Three patients had to be converted into open surgery (bleeding: two, unclear anatomy: one). No major complications were seen, but four patients had postoperative complications (stenosis requiring dilatation: one, subcutaneous emphysema: one, wound sepsis: one, hernia: one. The two latter complications were seen in converted patients). Two patients had prolonged dysphagia, and two patients needed slight dietetic advice for gasbloat syndrome. In 25 of 27 patients good control of GORD was accomplished as judged by symptomatology, endoscopy and 24-hour pH measurements. It is concluded that laparoscopic fundoplication offers good control of GORD with few complications, and short hospital stay and convalescence.

[24-hour esophageal pH in children]. / 24 timers esophagus-pH-måling på børn.

Continuous 24-hour esophageal pH-monitoring was performed in 89 infants. Of 38 patients with respiratory symptoms 74% were found to have a pathological 24-h pH monitoring. The same number of pathological monitorings (71%) were found in 38 patients with clinical symptoms of gastro-oesophageal reflux. We found pathological monitorings in only 25% of eight patients with unusual posturing and five healthy children all had normal monitorings. Gastrooesophageal reflux is common in children with clinical gastrointestinal symptoms as well as in children with respiratory symptoms.

Distal oesophageal motility characteristics in relation to amplitude of contraction in healthy persons.

OBJECTIVES: We wanted to supply a new 'vertical' approach in the analysis of oesophageal contraction data by describing variables of oesophageal function in relation to the amplitude of contraction. METHODS: Twenty-four-hour oesophageal manometry was performed in 20 healthy volunteers (11 women and 9 men; mean age, 47.5 years). Computer analysis was performed in pressure windows at 10, 15, 20, 30, 40, 50, 60, 70, and 80 mm Hg. Within each window two variables were extracted: the distribution (%) of peristaltic contractions and median duration (sec) of contractions. RESULTS: The percentage of peristaltic contractions increased with increasing amplitude of contractions during the upright position (15-20 mm Hg window: mean (+/- SD) 68.2% (+/- 13.3%), versus 70-80 mm Hg window: 85.0% (+/- 13.0%) (P < 0.001)) and meal periods (66.9% (+/- 13.8%) versus 92.2% (+/- 11.2%) (P < 0.001)) but not in the supine position (75.9% (+/- 14.6%) versus 73.5% (+/- 16.1%) (P = 0.64)). Contraction duration diminished with increasing contraction amplitude (upright, 15-20 mm Hg window: 3.2 sec (+/- 1.5 sec) versus 70-80 mm Hg window: 1.5 sec (+/- 1.0 sec) ( P < 0.0001); meal: 3.8 sec (+/- 1.7 sec) versus 1.9 sec (+/- 1.1 sec) (P < 0.01); supine: 4.1 sec (+/- 3.0 sec) versus 2.2 (+/- 1.5 sec) (P = 0.03)). The percentage of peristaltic contraction was lower during the supine periods than during meals and upright periods at high amplitudes (70-80 mm Hg window; P < 0.05). The number of contractions decreased linearly on a logarithmic scale with pressure window amplitude. CONCLUSIONS: Pressure wave amplitude and organization were closely related. Accurate base-line determination and delineation are critical for the interpretation of oesophageal manometric recordings.