Andrea Riphaus

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 RESULTS A total of 646,080 (223,656 published and 422,424 unpublished) EDP cases were identified.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

Sedation with propofol for interventional endoscopic procedures: a risk factor analysis.

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.

Electroencephalogram monitoring facilitates sedation with propofol for routine ERCP: A randomized, controlled trial

Objective. Propofol sedation for mainly diagnostic endoscopic procedures has proved safe in recent trials, with no need for endotracheal intubation. However, there is evidence that cardiorespiratory side effects occur more frequently and that assisted ventilation may be necessary if propofol sedation is performed for interventional endoscopic procedures. Material and methods. Over a 6-year period, all adverse events (defined as premature termination of the procedure due to sedation-related events or either the need for assisted ventilation or admission to ICU) occurring during 9547 endoscopic interventions (UGI, n=5.374, ERCP, n=3.937, EUS, n=236) under propofol sedation were assessed. Results. A total of 135 adverse events (1.4%) were documented. Assisted ventilation was necessary in 40 patients (0.4%); 9 patients required endotracheal intubation (0.09%); 28 needed further monitoring on the ICU (0.3%); and 4 patients died, 3 potentially due to sedation-related side effects (mortality, 0.03%). Independent risk factors for sedation-related side effects were emergency endoscopic examinations and a total propofol dose >100 mg. Conclusions. Interventional endoscopy under propofol sedation is not risk-free. Increased attention must be focused on close monitoring of vital parameters, particularly when undertaking long-lasting interventions and emergency 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.

BACKGROUND Endoscopy with the patient under sedation with propofol requires careful monitoring of patient consciousness and vital signs to achieve the desired hypnotic effect without overdosage. Because level of consciousness is difficult to judge by clinical observation alone, electroencephalogram monitoring has been used to guide general anesthesia. METHODS Eighty consecutive patients (mean [SD] age 62 [14] years) undergoing ERCP for various indications were randomly allocated to 2 groups. In group A (n = 40), propofol sedation was guided by conventional monitoring (heart rate, blood pressure, oxygen saturation, electrocardiogram), whereas electroencephalogram monitoring was performed but not displayed to the physician who administered the drug. In group B (n = 40), electroencephalogram monitoring was displayed online and used to guide propofol administration to maintain a preselected sedation level. Procedure-related parameters, recovery time, and quality (postanesthesia recovery score), as well as patient cooperation and tolerance for the procedure (visual analog scale) were prospectively assessed. RESULTS The groups were comparable with regard to demographic, clinical, and procedure-related parameters. Mean propofol dose was significantly lower in group B than in group A (respectively, 290 [158] mg vs. 374 [166] mg; p = 0.02). The mean decrease in arterial blood pressure was significantly lower in group B than in group A (respectively, 11 [6] mm Hg vs. 14 [7] mm Hg; p < 0.05). Clinically relevant changes in vital signs to below critical values were observed in both groups, albeit infrequently. Efficacy of sedation was also rated similar in both groups, whereas mean recovery time was significantly faster in group B than in group A (respectively, 16 [7] minutes vs. 20 [8] minutes; p = 0.02). Accordingly, the recovery score tended to be better in group B compared with group A (respectively, 8.4 [1.0] points vs. 8.0 [0.9] points; p = 0.06). The predefined target level of sedation was maintained during 75% of the procedure time in group B but in only 58% of the time in group A (p < 0.05), and deeper sedation levels were achieved significantly more often in group B patients compared with group A patients (p < 0.05). CONCLUSION Electroencephalogram monitoring enables more effective titration of propofol dosage for sedation during endoscopy and is, therefore, associated with faster patient recovery.

Capsule Endoscopy Interpretation by an Endoscopy Nurse - a Comparative Trial

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.

Hemorrhoidal elastic band ligation with flexible videoendoscopes: a prospective, randomized comparison with the conventional technique that uses rigid proctoscopes

BACKGROUND Capsule endoscopy is a common, pain-free diagnostic procedure for the small bowel. However, interpretation of the whole video recording is a time-consuming and costly procedure that can take up to 2 hours. The aim of the present study is two-fold: first to study the accuracy of capsule endoscopy analysis between a trained endoscopy nurse and a physician and secondly to determine if pre-evaluation by nursing staff might be time-effective for capsule reading. This study is especially important given the increasing financial pressure on current health-care systems. METHODS A long-standing experienced endoscopy nurse, who was trained to read capsule endoscopy, and a physician, both blinded to the patient diagnosis and the other clinical findings reviewed 48 consecutive capsule endoscopy videos. The analyses of both the nurse and the physician were re-evaluated by an independent doctor regarding the agreement of the marked findings. RESULTS Total time to read capsule endoscopy was significantly longer for the nurses interpretation (63 +/- 26 min) as compared to the physicians interpretation (54 +/- 18 min, p < 0.01). The endoscopy nurse marked 236 thumbnails, whereas the doctor only marked 132 thumbnails. The nurse overlooked 4 of 64 relevant lesions (6 %), which had been detected by the physician. These overlooked lesions were not single important lesions, they were overlooked only in patients with multiple angiectasias of the small intestine, and thus the misdiagnosis was without clinical relevance. The physician overlooked 6 of 68 lesions detected by the nurse (9 %), also in patients with multiple angiodysplastic lesions and therefore without clinical relevance. On post-hoc analysis of the capsule video recordings the time needed by the physician to interpret the thumbnails marked by the nurse was 10 +/- 12 min. While there was no difference with respect to the estimated gastric emptying time (nurse 27 +/- 13 min vs. physician 28 +/- 14 min, n. s.), the estimated time of capsule passage through the ileocaecal valve was longer when interpreted by the endoscopy nurse (nurse 347 +/- 89 min vs. physician 326 +/- 74 min, n. s.). Nevertheless, the total cost for capsule pre-evaluation by the nurse was lower (13.23 euro vs. physician 17.82 euro). CONCLUSION The endoscopy nurse detected 94 % of the significant lesions seen by the physician and no clinically relevant findings were overlooked. A pre-evaluation of the capsule video by trained staff is an accurate method and might be time effective.

Endoscopic pancreatic duct stenting for relief of pancreatic cancer pain.

BACKGROUND Elastic band ligation by means of a rigid proctoscope is the treatment of choice for patients with symptoms caused by internal hemorrhoids of grade 2 to 3. In contrast to the flexible videoendoscope, the rigid proctoscope has limited maneuverability, has a narrower field of view, and does not allow adequate documentation. Therefore, a randomized trial was conducted to compare the safety and the efficacy of conventional elastic band ligation with videoendoscopic elastic band ligation. METHODS A total of 100 consecutive patients (mean age 47 [12] years) with chronically bleeding grade 2 or 3 internal hemorrhoids were randomized to elastic band ligation or videoendoscopic elastic band ligation. For videoendoscopic elastic band ligation, a reusable multiband ligator was attached to the end of a therapeutic upper videoendoscope. From one to 3 bands were placed per session in both groups. Re-treatment was performed every 2 to 3 weeks in both groups until cessation of bleeding and eradication of the hemorrhoids (at least grade 2) were achieved. Thereafter, the patients were followed to assess complications and efficacy. Recurrent bleeding was considered a treatment failure. RESULTS To achieve the desired therapeutic aims, a significantly lower number of treatment sessions was required in the videoendoscopic elastic band ligation group (1.8 [0.8] vs. 2.4 [0.9]; p < 0.01) and the total number of bands applied was significantly less (2.8 [1.1] vs. 3.7 [1.4]; p < 0.01). Pain was noted after ligation by 25% of patients in the elastic band ligation group compared with 27% of those who had videoendoscopic elastic band ligation. However, analgesic medications were required in only 7% after elastic band ligation and 9% after videoendoscopic elastic band ligation (NS). Post-ligation bleeding that had to be treated endoscopically occurred in 3.5% of the patients of the elastic band ligation group and 3.2% of those in the videoendoscopic elastic band ligation group (NS). Blood transfusion was not required. At a median follow-up of 12 months, there was no recurrence of bleeding in 40 patients (80%) in the conventional elastic band ligation group vs. 43 (86%) in the videoendoscopic elastic band ligation (NS). CONCLUSIONS The long-term efficacy and safety of conventional elastic band ligation and videoendoscopic elastic band ligation are highly comparable. However, when videoendoscopic elastic band ligation is performed, significantly fewer treatment sessions are required.

Dual access endoscopic necrosectomy of infected pancreatic necrosis: a case report

Introduction Little is known about the effects of endoscopic pancreatic duct (PD) decompression in patients with ‘obstructive type’ pain from pancreatic carcinoma. Methods Twenty patients with unresectable carcinoma of the pancreas, PD obstruction and postprandial epigastric pain were enrolled. The pain intensity, opioid dose and quality-of-life index were documented pre-treatment and at 4-weekly intervals. PD stenting was attempted in all patients. PD stent change was performed if biliary stents had to be changed or intense pain relapsed. Results Endoscopic PD drainage was successful in 19/20 patients by placement of a 7 F (n=9) or 10 F (n=10) plastic stent. Median follow-up was 16 weeks. Two patients were alive at the end of follow-up. Eleven patients received gemcitabine chemotherapy. The pre-interventional pain score was 6.7±0.9 points and decreased to 3.1±1.4 points at 4 weeks (P<0.001). It remained lowered significantly at 8/12 weeks and at the final visit (4.2±1.5 points, n=13). The mean pre-stenting fentanyl dose was 85.5±34.7 μg/h, and it was decreased to 57.9±39.1 μg/h after 4 weeks (P<0.01), 60.5±38.9 μg/h after 8 weeks and 64.1±39.8 μg/h (P<0.01 versus pre-treatment) after 12 weeks but increased to 82.7±41.3 μg/h (NS) at the final visit. The quality-of-life index improved 4 weeks after stenting (from 4.8±1 to 6.2±1.5 points, P<0.01) but was lowered to 5.5±2.3 points at 12 weeks (NS). The response was independent of stent diameter and chemotherapy. Conclusion PD stenting achieved significant pain relief and short-term improvement of the quality of life in the majority of patients with PD obstruction due to pancreatic carcinoma.

Safety and efficacy of a newly developed baby-sphincterotome for cannulation and precut in cases of failed selective wire-guided bile duct access: a prospective 8-year clinical evaluation.

A 73-year-old male developed fever and jaundice 6 months after an episode of acute necrotizing pancreatitis. During endoscopic retrograde cholangiography, a distal bile duct compression was documented and stent insertion led to resolution of jaundice, however, the febrile condition persisted. A pancreatic necrosis measuring 11x7 cm was shown by computed tomography (CT) and the patient was referred for necrosectomy. During the first endoscopic session, spontaneous drainage of pus was observed in the duodenal bulb. Therefore, the pancreatic necrosis was first punctured under endoscopic ultrasound-guidance transduodenally. The pancreatic necrosis was then additionally punctured transgastrically and the necrotic cavity was entered with a standard upper gastrointestinal scope. Despite extensive irrigation and necrosectomy we felt the transgastric approach was not sufficient enough to treat the large necrotic cavity and decided to perform the further treatment by using both accesses. Endoscopic debridement was repeated daily through the transgastric as well as the transduodenal approach over 5 days. The clinical condition of the patient dramatically improved and he became afebrile. Two months after the initial endoscopic necrosectomy, a CT scan showed nearly complete resolution of the pancreatic necrosis and the bile duct stenosis resolved. Six months later, CT scans showed no residual necrosis and an atrophic but otherwise normal pancreas.

Endoscopic Resection of Submucosal Tumors of the Esophagus. A Prospective Case Series

Background Precut sphincterotomy (PCS) is a well-established alternative after repeated unsuccessful attempts of common bile duct (CBD) cannulation using standard catheters and/or guide-wire. Commonly used instruments for precutting are the needle-knife and a modified traction-type sphincterotome. In 1996, a so-called ‘baby-sphincterotome’ with a preshaped, small-caliber 3 Fr tip was developed, which enables cannulation and precutting in one step. Objective A clinical evaluation was carried out and the complication rates were determined at a tertiary referral hospital. Design Prospective clinical evaluation. Interventions During an 8-year period, a total of 5389 endoscopic retrograde cholangiopancreatographies were performed at our hospital. In total, 1886 patients fulfilled the inclusion criteria for this prospective study. The baby-sphincterotome was used in 345 of 1886 patients (mean age 63.4±16.4 years, 203 women) after five unsuccessful attempts of CBD cannulation using a hydrophilic guide-wire. After two more failed CBD cannulations with the baby-sphincterotome, PCS was performed using the same device. Main outcome measurements The success rates of biliary access, postendoscopic retrograde cholangiopancreatography pancreatitis, and bleeding were assessed. Results Initially, the success rate of CBD cannulation on using the baby-sphincterotome was 28% (96/345 patients). Postinterventional pancreatitis occurred in two of 96 patients (2%) and minor bleeding occurred during traction-type sphincterotomy in four of 93 patients (4%). In the remaining 249 patients precut with a baby-sphincterotome, CBD cannulation was achieved in 219 cases (88%), although with pancreatitis and severe bleeding in 4% each. In 30 of 249 patients (12%), a second or a third (n=5) intervention was necessary, with a success rate of 73% (22/30 cases) after PCS. Limitations This was a single-centre, uncontrolled study. Conclusion The newly developed baby-sphincterotome enables bile duct access in a single session in 91% of the patients when guide-wire cannulation has failed. Direct cannulation was possible in about one–quarter of the patients, whereas PCS with the new device showed a high efficacy and a low complication rate.