Outcomes of pneumatic dilation in achalasia: Extended follow-up of more than 25 years with a focus on manometric subtypes.

BACKGROUND AND AIM: Pneumatic dilation (PD) is the most popular nonsurgical treatment for achalasia. This study investigated predicting factors, including manometric subtypes for symptom recurrence in the long term, in patients with achalasia treated with a single PD. METHODS: Between 1983 and 2013, a total of 107 patients were treated initially with a single PD and included in this longitudinal cohort study. Outcomes were correlated with demographics, symptoms (Eckardt score), and esophagographic and manometric features. Manometric tracings were retrospectively classified according to the three subtypes of the Chicago classification. RESULTS: Ninety-one (85%) patients were successfully treated after the first PD. The median follow-up was 13.8 years (interquartile range 7-20). During follow-up, 54% of the patients experienced a clinical relapse. The overall cumulative success rates at 2, 5, 10, 15, 20, and 25 years were 64%, 53%, 49%, 42%, 36%, and 36%, respectively. Age < 40 years, lower esophageal sphincter pressure > 15 mmHg, a cardia width < 5 mm, and an esophageal barium column height > 1 cm 4 to 12 weeks post-dilation significantly correlated with symptom recurrence, whereas achalasia subtypes did not significantly correlate with the treatment results. CONCLUSION: Pneumatic dilation in achalasia is an effective therapy in the short term, but its effect wanes in the very long term. Young age at presentation, a high lower esophageal sphincter pressure, a narrow cardia, and an esophageal barium column of > 1 cm after PD are predictive factors for the need of repeated treatment.

[The revised version of standard terminology in gastroenterological endoscopy - result of a consensus project of the german society for gastroenterology, digestive and metabolic diseases]. / Neufassung der Standard-Terminologie in der gastroenterologischen Endoskopie ­ Ergebnis eines Konsensusprojekts der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten.

A uniform and comprehensive terminology is essential in the correct documentation of diagnostic or therapeutic endoscopic procedure. In the German-speaking world, the standard terminology available so far is based on a previous version published in 1999. Therefore, the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS) has undergone a comprehensive revision and re-structuring of the terminology. This appeared mandatory due to various changes, new diagnoses and new endoscopic procedures. The suggestions drawn up by individual working groups were approved by consensus and are now available as an online document (https://doi.org/10.1055/s-0043-121167) for modifying current software systems. In order to ensure an up-to-date documentation in the future, it was decided that annual updates will be performed by the DGVS to check respective software packages for modifications and new contents.

Capnographic monitoring of midazolam and propofol sedation during ERCP: a randomized controlled study (EndoBreath Study).

BACKGROUND AND STUDY AIMS: This was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxemia during midazolam and propofol sedation for endoscopic retrograde cholangiopancreatography (ERCP). METHODS: Patients (American Society of Anesthesiologists [ASA] I ­â€ŠIV) scheduled for ERCP under midazolam and propofol sedation were randomly assigned to a control arm with standard monitoring or an interventional arm with additional capnographic monitoring. In both arms detection of apnea prompted withholding of propofol administration, stimulation of the patient, insertion of a nasopharyngeal tube, or further measures. The primary study end point was incidence of hypoxemia (oxygen saturation [Sao 2] below 90 %); secondary end points included occurrences of severe hypoxemia (Sao 2 ≤ 85 %), bradycardia, and hypotension, and sedation quality (patient cooperation and satisfaction). RESULTS: 242 patients were enrolled at three German endoscopy centers. Intention-to-treat analysis revealed no significant reduction in hypoxemia incidence in the capnography arm compared with the standard arm (38.0 % vs. 44.4 %, P = 0.314). Apnea was more frequently detected in the capnography arm (64.5 % vs. 6.0 %, P < 0.001). There were no differences regarding rates of bradycardia and hypotension. Per-protocol analysis showed lower incidence of hypoxemia in the capnography arm compared with the standard arm (31.5 % vs. 44.8 %, P = 0.048). There was one death related to sedation in the standard arm. Sedation quality was similar in the two groups. CONCLUSION: Intention-to-treat analysis showed hypoxemia incidence was not significantly lower in the additional capnography arm compared with standard monitoring. Additional capnographic monitoring of ventilatory activity resulted in improved detection of apnea.

Prospective evaluation of the routine use of a nasopharyngeal airway (Wendl Tube) during endoscopic propofol-based sedation.

BACKGROUND/AIMS: Insertion of a nasopharyngeal airway (NPA) during endoscopic sedation is only recommended in the event of respiratory problems. We evaluated the safety and efficacy of routine insertion of an NPA during sedation in gastrointestinal (GI) endoscopy. METHODS: Between July 2009 and April 2012, patients with colonoscopy or expected longer-lasting or therapeutic upper GI endoscopy were pseudo-randomized in a weekly alternating fashion to perform sedation (midazolam in combination with propofol) with or without NPA insertion. The primary outcome measure was respiratory depression (oxygen saturation <90%). Secondary measures included hypotension (systolic blood pressure <90 mm Hg), bradycardia (heart rate <40 beats/min) or nasopharyngeal damage after NPA insertion. RESULTS: 216 (106 females, mean age 60.7 ± 9.65 years) were enrolled. Colonoscopy was performed in 131 patients and upper endoscopy in 85 patients. In 105 patients an NPA was used (intervention group). Five (4.7%) of those patients showed minor nasopharyngeal injury. Respiratory depression (13.5 vs. 1.9%, p = 0.002) and hypotension (11 vs. 5%, p = 0.09) occurred more frequently in the control than in the intervention group. CONCLUSION: The routine placement of an NPA can reduce the frequency of hypoxemic events during endoscopic sedation with minor risks for nasopharyngeal injury.

Miniprobe endoscopic ultrasound accurately stages esophageal cancer and guides therapeutic decisions in the era of neoadjuvant therapy: results of a multicenter cohort analysis.

BACKGROUND: Despite recent advances in imaging techniques, adequate classification of esophageal lesions is still challenging. Accurate staging of tumors of the esophagus is a precondition for targeted therapy. In this retrospective, multicenter study, we report the role of high-frequency endoscopic ultrasound (EUS) catheter probes in pretherapeutic staging of esophageal neoplasms and thus guiding treatment decisions. METHODS: A total of 143 patients (mean age of 63.8 ± 10.7 years) with esophageal carcinoma were recruited from five German centers (Münster, Oldenburg, Hannover, Wiesbaden, and Lüneburg). Tumor type was adenocarcinoma in 112 (78 %) cases and squamous cell carcinoma in 31 (22 %). Tumor localization was as follows: proximal 3, mid esophagus 7, and distal third 133. Histological correlation either through EMR or surgery was available. In all patients, pretherapeutic uT and uN classifications were compared to pT/pN classification obtained from surgically (esophagectomy, n = 93) or endoscopically (EMR, n = 50) resected tissue. RESULTS: Overall, accuracy of uT classification was 60 % and of uN classification was 74 %. Sensitivity, specificity, and accuracy rates for local tumor extension were as follows (%): T1: 68/97/83; T2: 39/84/75; T3: 72/81/79; T4: 13/97/93; T1/2: 73/81/75; T3/4: 78/82/81. Relating to positive lymph node detection, sensitivity and specificity were 76 and 71 %, respectively. CONCLUSIONS: Miniprobe EUS is an established method for the staging of esophageal tumors. Our large multicenter cohort shows a solid accuracy of miniprobe EUS with respect to differentiating locally advanced from limited cancer and assisting to determine the treatment regimen in the era of neoadjuvant therapy; consequently, 78 % of patients would have been assigned to the adequate therapeutic regimen, whereas 11 % of patients would have been overtreated and 11 % undertreated.

Capnographic monitoring reduces the incidence of arterial oxygen desaturation and hypoxemia during propofol sedation for colonoscopy: a randomized, controlled study (ColoCap Study).

OBJECTIVES: The aim of this randomized study was to determine whether intervention based on additional capnographic monitoring reduces the incidence of arterial oxygen desaturation during propofol sedation for colonoscopy. METHODS: Patients (American Society of Anesthesiologists classification (ASA) 1-3) scheduled for colonoscopy under propofol sedation were randomly assigned to either a control arm with standard monitoring (standard arm) or an interventional arm in which additional capnographic monitoring (capnography arm) was available. In both study arms, detection of apnea or altered respiration induced withholding propofol administration, stimulation of the patient, chin lift maneuver, or further measures. The primary study end point was the incidence of arterial oxygen desaturation (defined as a fall in oxygen saturation (SaO(2)) of ≥5% or <90%); secondary end points included the occurrences of hypoxemia (SaO(2) <90%), severe hypoxemia (SaO(2) ≤85%), bradycardia, hypotension, and the quality of sedation (patient cooperation and patient satisfaction). RESULTS: A total of 760 patients were enrolled at three German endoscopy centers. The intention-to-treat analysis revealed a significant reduction of the incidence of oxygen desaturation in the capnography arm in comparison with the standard arm (38.9% vs. 53.2%; P<0.001). The numbers of patients with a fall in SaO(2) <90% and ≤85% were also significantly different (12.5% vs. 19.8%; P=0.008 and 3.7 vs. 7.8%; P=0.018). There were no differences regarding the rates of bradycardia and hypotension. Quality of sedation was similar in both groups. Results of statistical analyses were maintained for the per-protocol population. CONCLUSIONS: Additional capnographic monitoring of ventilatory activity reduces the incidence of oxygen desaturation and hypoxemia during propofol sedation for colonoscopy.

Intermittent manually controlled versus continuous infusion of propofol for deep sedation during interventional endoscopy: a prospective randomized trial.

INTRODUCTION: Beside the traditional, intermittent bolus application of propofol, continuous propofol infusion via infusion pump is an alternative procedure for deep sedation during long-lasting interventional endoscopy. However, up to now, there are no randomized comparisons for gastrointestinal endoscopy. METHODS: One hundred patients (ERCP: n = 60, EUS: n = 40) were randomly assigned to receive intermittent bolus application ("bolus group") or continuous infusion ("perfusor group") of propofol sedation after induction with 3 mg midazolam for deep sedation. Patients in the bolus group received an initial propofol dose according to body weight (bw <70 kg: 40 mg; bw ≥ 70 kg 60 mg). In the perfusor group, bw-adapted, continuous propofol infusion (6 mg/kg) via the Injectomat 2000 MC (Fresenius-Kabi) was administered after an initial bolus of 1 mg/kg. Vital signs, dose of propofol, patient cooperation (VAS 1-10), sedation depth, and the recovery time as well as the quality of recovery were evaluated. RESULTS: Total propofol dose in the bolus group 305 ± 155 mg (100-570 mg) and in the perfusor group 343 ± 123 mg (126-590 mg, p = 0.5) were comparable. Oxygen saturation below 90% was seen in four patients of each group, with no need for assisted ventilation. Arterial blood pressure <90 mmHg was documented in two patients in the bolus group and seven patients in the perfusor group (p = 0.16). Patients' cooperation was rated as good in both groups (bolus group, 9.1 ± 0.9; perfusor group, 8.9 ± 1; p = 0.17). Recovery time was significantly shorter in the bolus group compared with the perfusor group (19 ± 5 versus 23 ± 6 min, p < 0.001) whereas the quality of recovery was nearly identical in both groups. CONCLUSION: Both sedation regimens allow nearly identical good controllability of propofol sedation. However, recovery time was significantly slower and hypotension was tended to occur more often in the perfusor group.

Extracorporeal shock wave lithotripsy with a transportable mini-lithotripter and subsequent endoscopic treatment improves clinical outcome in obstructive calcific chronic pancreatitis.

BACKGROUND: Extracorporeal shock wave lithotripsy (ESWL) of pancreatic duct stones followed by ERCP with mechanical clearance of the pancreatic duct and subsequent stenting is an established treatment option for chronic calcific pancreatitis. OBJECTIVE: To test the efficacy of a modified transportable mini-lithotripter for ESWL of pancreatic duct stones. DESIGN: Prospective single-center study. SETTING: University hospital. PATIENTS: This study involved 32 patients with obstructive chronic calcific pancreatitis and pain in whom previous endoscopic stone removal and pancreatic duct decompression had failed. INTERVENTIONS: ESWL followed by ERCP for stone clearance of the pancreatic duct and mechanical removal of stones or stenting. MAIN OUTCOME MEASUREMENTS: Endoscopic duct clearance and/or stent insertion, pain and quality-of-life scores. RESULTS: A median of 4 ESWL sessions (interquartile range 2.75-8.5) with a median of 6800 shock waves (4225-15,425) were required. Pain relief after ESWL only was noted in 24 patients (75.0%), whereas no change in the intensity of pain was reported by 7 patients (21.9%), and pain was worse in 1 patient. All patients underwent ERCP and stent placement, resulting in complete resolution of pain in 17 patients (53.1%) and pain improvement in 28 patients (87.5%). The quality-of-life score was significantly improved after ESWL and endoscopic clearance or stenting in all patients. LIMITATIONS: Uncontrolled study. CONCLUSIONS: ESWL with the mini-lithotripter results in fragmentation of pancreatic duct calculi. ESWL in conjunction with endoscopic clearance of the pancreatic duct and stenting is associated with significant improvement in clinical outcome and quality of life in patients with obstructive calcific chronic pancreatitis.

Endoscopist-directed administration of propofol: a worldwide safety experience.

BACKGROUND & AIMS: Endoscopist-directed propofol sedation (EDP) remains controversial. We sought to update the safety experience of EDP and estimate the cost of using anesthesia specialists for endoscopic sedation. METHODS: We reviewed all published work using EDP. We contacted all endoscopists performing EDP for endoscopy that we were aware of to obtain their safety experience. These complications were available in all patients: endotracheal intubations, permanent neurologic injuries, and death. RESULTS: A total of 646,080 (223,656 published and 422,424 unpublished) EDP cases were identified. Endotracheal intubations, permanent neurologic injuries, and deaths were 11, 0, and 4, respectively. Deaths occurred in 2 patients with pancreatic cancer, a severely handicapped patient with mental retardation, and a patient with severe cardiomyopathy. The overall number of cases requiring mask ventilation was 489 (0.1%) of 569,220 cases with data available. For sites specifying mask ventilation risk by procedure type, 185 (0.1%) of 185,245 patients and 20 (0.01%) of 142,863 patients required mask ventilation during their esophagogastroduodenoscopy or colonoscopy, respectively (P < .001). The estimated cost per life-year saved to substitute anesthesia specialists in these cases, assuming they would have prevented all deaths, was $5.3 million. CONCLUSIONS: EDP thus far has a lower mortality rate than that in published data on endoscopist-delivered benzodiazepines and opioids and a comparable rate to that in published data on general anesthesia by anesthesiologists. In the cases described here, use of anesthesia specialists to deliver propofol would have had high costs relative to any potential benefit.

Extended monitoring of the sedated patient: bispectral index, Narcotrend and automated responsiveness monitor.

It has been demonstrated that a processed EEG derivative may reflect the patient's level of consciousness during endoscopic sedation. However, to date a clinical benefit of EEG monitoring with respect to relevant safety parameters in routine gastrointestinal endoscopy has not been demonstrated. During long-lasting procedures (e.g. ERCP, ESD) a propofol-sparing effect has been shown, but a benefit regarding patient safety could not be documented. The use of an automated responsiveness monitor may help to achieve and to maintain the level of conscious sedation with propofol, but its precise role in endoscopic sedation is undefined.

Propofol sedation in gastrointestinal endoscopy: a gastroenterologist's perspective.

The present article describes the recommendations regarding the use of propofol by non-anesthesiologists from published guidelines. Furthermore, safety and efficacy data regarding the use of propofol in the hands of gastroenterologists are also reviewed. Although there are no studies comparing the safety and efficacy of propofol administration by anesthesiologists versus non-anesthesiologists for sedation during endoscopy, there is strong evidence that propofol administration by non-anesthesiologists is safe and efficacious for the majority of patients undergoing routine endoscopic procedures.

Propofol sedation for upper gastrointestinal endoscopy in patients with liver cirrhosis as an alternative to midazolam to avoid acute deterioration of minimal encephalopathy: a randomized, controlled study.

OBJECTIVE: Midazolam sedation for upper gastrointestinal (GI) endoscopy exacerbates minimal hepatic encephalopathy (HE) in patients with liver cirrhosis, therefore an alternative drug regimen for these patients is warranted. The aim of this randomized, controlled study was to assess whether the use of the short-acting propofol as a sedative for GI endoscopy could prevent the exacerbation of minimal HE in patients with liver cirrhosis. MATERIAL AND METHODS: The study comprised patients with liver cirrhosis without clinical HE who had undergone upper GI endoscopy for therapeutic purposes (intended variceal band ligation). Sixty patients were randomly assigned into two groups to receive propofol (n=40) or midazolam (n=20) for upper GI endoscopy. The study groups were matched for age, gender and Child-Pugh score. All patients completed number connecting tests (NCTs), as well as a porto-systemic encephalopathy (PSE) syndrome test before and at 2 h after completion of the endoscopic procedure. Time needed to fulfill the tests was documented. Baseline results of the psychomotor test batteries were compared with the post-interventional evaluations. Data were also compared with the results of a healthy control group (n=20) that did not undergo endoscopic sedation. Recovery time and quality (score system) were evaluated. RESULTS: The differences in the NCT times before and after sedation (median delta NCT, midazolam group, 11 s (95% CI, -1.2 to 16.1 s) versus the propofol group, -9.5 s (95% CI, -15.7 to -4.6 s), p=0.002) and in the PSE scores (median delta PSE, midazolam group, -1 (95% CI, -1.5 to 0.2) versus the propofol group, 1 (95% CI, 0.5 to 1.5), p=0.0009) differed significantly between the two groups. In addition, the recovery time and quality in patients receiving propofol were significantly improved compared with in the midazolam group (7.8+/-2.9 min versus 18.4+/-6.7 min, 6.1+/-1.1 versus 8.2+/-1.3, both p<0.001). CONCLUSIONS: The study demonstrates that propofol sedation for upper GI endoscopy does not cause acute deterioration of minimal hepatic encephalopathy and is associated with improved recovery in patients with liver cirrhosis. Propofol should be recommended for these patients as an alternative to midazolam.

Clinical value of the Integrated Pulmonary Index® during sedation for interventional upper GI-endoscopy: A randomized, prospective tri-center study.

BACKGROUND AND STUDY AIMS: The Integrated Pulmonary Index® (IPI) is a mathematically-determined factor based on parameters of capnography and pulse oximetry, which should enable sensitive detection of impaired respiratory function. Aim was to investigate whether an additional measurement of the IPI during sedation for interventional endoscopy, compared to standard monitoring alone, allows a reduction of sedation-related respiratory depression. PATIENTS AND METHODS: 170 patients with standard monitoring randomly underwent either a blinded recording of capnography (control group, n=87) or capnography, including automated IPI calculation (IPI group, n=83), during deep sedation with midazolam and propofol. The primary endpoint was the maximum decrease of oxygen saturation from the baseline level before sedation. Secondary endpoints: incidence of hypoxemia (SaO2<90%), other sedation-related complications (apnea rate, bradycardia, hypotension), patient cooperation and satisfaction (VAS). RESULTS: Mean propofol dose in the IPI group (245±61mg) was comparable to the control group (225±47mg). The average drop of the oxygen saturation in the IPI group (6.5±4.1%) was nearly identical to that of the control group (7.1±4.6%, p=0.44). Apnea episodes >15s was found in 46 patients of the control and 31 of the IPI group (p<0.05). Frequency of occurrence of a drop in pO2-saturation <90%, bradycardia <50/min or a drop of systolic pressure <90mmHg were not significantly different in both groups. Mechanical ventilation was not required in any case. Patient cooperation and satisfaction were assessed similar in both groups. CONCLUSION: A clinically appealing advantage of IPI-assessment during deep sedation with midazolam and propofol for interventional endoscopy could not be documented. However, IPI registration was more effective in reducing the incidence of apnea episodes.