Predictors of Early Failure After Fecal Microbiota Transplantation for the Therapy of Clostridium Difficile Infection: A Multicenter Study.

OBJECTIVES: Fecal microbiota transplant (FMT) is a highly efficacious treatment for recurrent or refractory Clostridium difficile infection (CDI); however, 10-20% of patients fail to achieve cure after a single FMT. The aim of this study was to identify risk factors associated with FMT failure and to develop and validate a prediction model for FMT failure. METHODS: Patient characteristics, CDI history, FMT characteristics, and outcomes data for patients treated between 2011 and 2015 at three academic tertiary referral centers were prospectively collected. Early FMT failure was defined as non-response or recurrence of diarrhea associated with positive stool C. difficile toxin or PCR within 1 month of FMT. Late FMT failure was defined as recurrence of diarrhea associated with positive stool C. difficile toxin or PCR between 1 and 3 months of the FMT. Patient data from two centers were used to determine independent predictors of FMT failure and to build a prediction model. A risk index was constructed based on coefficients of final predictors. The patient cohort from the third center was used to validate the prediction model. RESULTS: Of 328 patients in the developmental cohort, 73.5% (N=241) were females with a mean age of 61.4±19.3 years; 19.2% (N=63) had inflammatory bowel disease (IBD), and 23.5% (N=77) were immunocompromised. The indication for FMT was recurrent CDI in 87.2% (N=286) and severe or severe-complicated in 12.8% (N=42). FMT was performed as an inpatient in 16.7% (N=54). The stool source was patient-directed donors in 40% (N=130) of cases. The early FMT failure rate was 18.6%, and the late failure rate was 2.7%. In the multivariable analysis, predictors of early FMT failure included severe or severe-complicated CDI (odds ratio (OR) 5.95, 95% confidence interval (CI): 2.26-15.62), inpatient status during FMT (OR 3.78, 95% CI: 1.55-9.24), and previous CDI-related hospitalization (OR 1.43, 95% CI: 1.18-1.75); with each additional hospitalization, the odds of failure increased by 43%. Risk scores ranged from 0 to 13, with 0 indicating low risk, 1-2 indicating moderate risk, and ≥3 indicating high risk. In the developmental cohort, early FMT failure rates were 5.6% for low risk, 12.7% for moderate risk, and 41% for high-risk patients. Of 134 patients in the validation cohort, 57% (N=77) were females with a mean age of 66±18.1 years; 9.7% (N=13) had IBD, and 17.9% (N=24) were immunocompromised. The early FMT failure rate at 1 month was 19.4%, with an additional 3% failing by 3 months. In the validation cohort, FMT failure rates were 2.1% for low risk, 16.1% for moderate risk, and 35.7% for high risk patients. The area under the receiver operating characteristic curve (AUROC) for FMT failure was 0.81 in the developmental cohort and 0.84 in the validation cohort. CONCLUSIONS: Severe and severe-complicated indication, inpatient status during FMT, and the number of previous CDI-related hospitalizations are strongly associated with early failure of a single FMT for CDI. The novel prediction model has good discriminative power at identifying individuals who are at high risk of failure after FMT therapy and may assist the treating physician in subsequent management plans.

A low-residue diet improved patient satisfaction with split-dose oral sulfate solution without impairing colonic preparation.

BACKGROUND: Preprocedural dietary restrictions have been identified as a common reason potential candidates for colorectal cancer screening do not undergo colonoscopy as recommended. OBJECTIVE: To study whether a low-residue diet impacts bowel preparation with oral sulfate solution. DESIGN: Endoscopist blinded, prospective, randomized controlled trial. SETTING: Community-based outpatient ambulatory surgical center. PATIENTS: Patients scheduled for outpatient colonoscopy. INTERVENTIONS: Subjects were randomized to ingest either a low-residue diet of specified foods for breakfast, lunch, and snack or a clear liquid diet the day before the colonoscopy. MAIN OUTCOME MEASUREMENTS: The quality of the bowel preparation was assessed using the Boston Bowel Preparation Scale. Subject satisfaction with bowel preparation, diet, and severity of side effects was measured by a visual analog scale. RESULTS: Two hundred thirty subjects were recruited (114 clear liquid and 116 low residue). Mean preparation scores were not statistically different in either their segmental scores or total score. Subjects in the low-residue arm reported significantly higher satisfaction with bowel preparation medication, diet, and entire preparation process. Observed rates of side effects were low, and there was no statistical difference between the two groups. The rate of procedural cancellation was significantly higher in the clear liquid group compared with the low-residue group (20% vs 9%, P = .03). LIMITATIONS: Single-center study. CONCLUSIONS: A low-residue diet did not impair the quality of bowel preparation achieved with split-dose oral sulfate solution but did improve patient satisfaction.

Endoscopic retrograde cholangiopancreatography and manometry findings in 1,241 idiopathic pancreatitis patients.

BACKGROUND: 10-30% of patients with pancreatitis are classified as idiopathic after the initial evaluation. Our aim was to assess the diagnostic yield of endoscopic retrograde cholangiopancreatography (ERCP) and sphincter of Oddi manometry in patients with idiopathic pancreatitis in a tertiary referral center. METHODS: A single-center, retrospective study analyzing the ERCP and manometry results of 1,241 patients who were classified as having idiopathic pancreatitis based upon their initial evaluation. RESULTS: A single episode of pancreatitis occurred in 20.4%, acute recurrent pancreatitis in 56.3% and chronic pancreatitis in 23.3% of the patients undergoing ERCP. Sphincter of Oddi dysfunction was found in 40.3% and pancreas divisum in 18.8% of the patients. Biliary stone disease was found in 3.0%. Intraductal papillary mucinous neoplasms were identified in 52 patients with increasing frequency in older age groups. The overall diagnostic yield of ERCP and sphincter of Oddi manometry to elucidate a potential cause of pancreatitis was 65.8%. Of these, 91.9% patients had findings amenable to endoscopic therapy. The complication rate was 11.5%. CONCLUSIONS: In this large series, ERCP with manometry frequently identified conditions which probably caused or contributed to the idiopathic pancreatitis. Long-term studies are awaited to determine outcomes after correctable factors are addressed. and IAP.

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.

A prospective safety study of a low-dose propofol sedation protocol for colonoscopy.

BACKGROUND & AIMS: Propofol has been shown to be an effective method for endoscopic sedation but there are few studies of low-dose propofol protocols for gastrointestinal endoscopy. METHODS: One hundred patients (American Society of Anesthesiology classes I-III) undergoing outpatient colonoscopy were enrolled prospectively in a multidrug propofol regimen that consisted of propofol, midazolam, and meperidine. Study outcome measures evaluated the level of sedation, length of procedure, sedation/recovery time, patient satisfaction, and adverse events. RESULTS: The mean dose of propofol was 90 +/- 40 mg. The mean times for induction of sedation, reaching the cecum, and total procedure time were 3 +/- 1 minutes, 5 +/- 3 minutes, and 17 +/- 4 minutes, respectively. Deep sedation was observed in only 0.3% of observations. Postprocedure, the mean times to stand at the bedside without assistance, completion of all discharge criteria, and actual discharge were 10 +/- 8 minutes, 20 +/- 20 minutes, and 37 +/- 23 minutes, respectively. Patient satisfaction ratings were high on a 10-point scale, with mean total procedure and sedation satisfaction scores of 9.4 +/- 0.8 and 9.4 +/- 1.1. In 99% of patients, no supplemental oxygen was required. No serious adverse events occurred. CONCLUSIONS: This protocol for propofol administration is safe and effective for patients undergoing elective colonoscopy. The level of sedation was titrated readily to a moderate level of sedation while preserving a high degree of patient satisfaction.

Propofol versus midazolam/meperidine for outpatient colonoscopy: administration by nurses supervised by endoscopists.

BACKGROUND: Propofol is under evaluation as a sedative for endoscopic procedures. METHODS: Eighty outpatients (ASA Class I or II) undergoing colonoscopy were randomized to receive either propofol or midazolam plus meperidine, administered by a nurse and supervised by an endoscopist. Endpoints were patient satisfaction, procedure and recovery times, neuropsychological function, and complications. RESULTS: The mean dose of propofol administered was 218 mg; mean doses of midazolam and meperidine were, respectively, 4.7 mg and 89.7 mg. Mean time to sedation was faster in the propofol patients (2.1 min vs. 7.0 min; p < 0.0001), and depth of sedation was greater (p < 0.0001). On average, after the procedure, the propofol patients could stand at the bedside sooner (14.2 vs. 30.2 min), reached full recovery faster (14.4 vs. 33.0 min), and were discharged sooner (40.5 vs. 71.1 min) (all p < 0.0001). Patients who received propofol also expressed greater overall mean satisfaction on a 10-point visual analog scale (9.3 vs. 8.6; p < 0.05). At discharge, the propofol group had better scores on tests reflective of learning, memory, working memory span, and mental speed. Four patients in the midazolam/meperidine group developed minor complications (1 hypotension and bradycardia, 2 hypotension alone, and 1 tachycardia) and 1 patient in the propofol group had oxygen desaturation develop during an episode of epistaxis. CONCLUSION: For outpatient colonoscopy, propofol administered by nurses and supervised by endoscopists has several advantages over midazolam plus meperidine and deserves additional investigation.