Peter V. Draganov

Long-term outcomes for patients with post-liver transplant anastomotic biliary strictures treated by endoscopic stent placement.

BACKGROUND Biliary stricture is one of the most common complications of liver transplantation. A number of treatment options are available, but a standard approach has not been established. METHODS A total of 25 patients with post-liver transplantation anastomotic strictures were treated endoscopically by stent placement. Long-term outcomes (bile duct patency, morbidity, and mortality) were reviewed retrospectively. RESULTS Placement of a stent was attempted in 25 patients with anastomotic stricture. Successful stent placement with stricture resolution at the time of stent removal was noted in 22 patients (technical success 88%). In those 22 patients, long-term success (mean follow-up after all stents removed, 54 months) was observed in 20 patients (90%) and partial success in two (10%). Long term, failure did not occur in any patient. There was no procedure- or disease-related mortally. Three mild episodes of cholangitis occurred during the period while the stents were in place, in relation to 79 endoscopic interventions for a procedure-related complication rate of 3.7%. CONCLUSIONS The long-term outcome for patients with post-liver transplantation biliary anastomotic strictures treated with endoscopic stent placement is excellent, with no therapy- or disease-associated mortality and minimal morbidity.

Efficacy and safety of endoscopic balloon dilation of symptomatic upper and lower gastrointestinal Crohn's disease strictures.

Goals: To evaluate efficacy and safety of endoscopic balloon dilation with or without intralesional steroid injection, of symptomatic upper gastrointestinal (UGI) and lower gastrointestinal (LGI) Crohns disease (CD) strictures. Background: Patients with CD commonly develop obstructive symptoms secondary to gastrointestinal strictures. When these do not resolve with medical management, surgery is usually the only alternative. Limited data are available on the safety and efficacy of endoscopic through-the-scope (TTS) balloon dilation of CD strictures. Study: We performed a retrospective review of TTS balloon dilations done on CD-related UGI and LGI strictures. Postdilation intralesional steroid injections were done at the discretion of the endoscopist. Stricture was defined as luminal stenosis <10 mm in diameter, through which a scope could not be passed. Technical success was defined as the ability of the scope to traverse the stricture postdilation. Long-term success rate was claimed if a patient remained asymptomatic and did not require surgery or further endoscopic dilation. Results: Over 4 years, we performed 29 stricture dilations on 17 patients (10 female, 7 male) with 20 strictures. The mean follow-up period was 18.8 months (range, 5-50 months). Stricture locations were as follows: rectal, 5; sigmoid colon, 2; colo-colonic anastomosis, 3; ileocolonic anastomosis, 4; ileum, 1; descending colon, 1; cecum, 1; and distal duodenal bulb, 3 patients. Technical success was achieved in 28 of 29 stricture dilations (96.5%). Ten strictures (34.5%) were dilated to <15 mm and 19 (65.5%) to ≥15 mm diameter. Long-term success rate in the <15 mm group was 70%, and in ≥15 mm group was 68.4%. Four quadrant steroid injections were done on 11 strictures. The recurrence rate in this group was 10% and that in the nonsteroid group was 31.3%. The overall long-term success rate was 76.5% by intent-to-treat analysis. Three perforations occurred (all colonic) during 29 stricture dilations, a complication rate of 10% with no mortalities. Conclusion: We report the first series of TTS balloon dilations with or without intralesional steroid injection, of both primary and anastomotic UGI and LGI strictures in CD patients. Long-term success was achieved in 76.5% patients with a complication rate of 10%. This mode of therapy appears safe and effective and can be considered as an alternative to surgery in selected patients with medically refractory CD-associated GI strictures. Success rates were better in patients who received four quadrant steroid injections. No difference was seen in stricture recurrence rate or complications based on diameter of TTS balloon used.

Diagnostic accuracy of conventional and cholangioscopy-guided sampling of indeterminate biliary lesions at the time of ERCP: a prospective, long-term follow-up study

BACKGROUND The diagnostic accuracy of cholangioscopy-guided sampling has not been rigorously evaluated. OBJECTIVE To prospectively evaluate the accuracy of cholangioscopy-guided mini-forceps sampling and compare it with standard cytology brushings and forceps biopsies for the tissue diagnosis of indeterminate biliary lesions. DESIGN Prospective, long-term follow-up, paired design cohort study. SETTING Tertiary center. PATIENTS Patients undergoing cholangioscopy for the evaluation of indeterminate biliary lesions. INTERVENTIONS Each patient underwent triple sampling with cholangioscopy-guided mini-forceps, cytology brushing, and standard forceps. MAIN OUTCOME MEASUREMENTS Diagnostic accuracy of each sampling method compared with the patient final status (cancer vs no cancer). RESULTS A total of 26 patients (17 cancer positive/9 cancer negative) were enrolled. The mean follow-up in the patients with no cancer was 21.78 (SD ±6.78) months. The procedure was technically successful in all cases (100%). Sample quality was adequate in 25 of 26 (96.2%) of the cytology brushings, in 26 of 26 (100%) of the standard forceps biopsies, and in 25 of 26 (96.2%) of the mini-forceps biopsies. The sensitivity, accuracy, and negative predictive values were 5.9%, 38.5%, and 36% for standard cytology brushings; 29.4%, 53.8%, and 42.8% for standard forceps biopsies; and 76.5%, 84.6%, and 69.2% for mini-forceps biopsies, respectively. When comparing the 3 methods of sampling, mini-forceps biopsy provided significantly better sensitivity and overall accuracy compared with standard cytology brushing (P < .0001) and standard forceps biopsy (P = .0215). LIMITATIONS Potential for selection bias. CONCLUSIONS Cholangioscopy-guided biopsies of indeterminate biliary lesions have significantly higher accuracy compared with ERCP-guided cytology brushings and standard forceps biopsies, but negative findings on mini-forceps biopsy cannot rule out malignancy with a high degree of certainty. ( CLINICAL TRIAL REGISTRATION NUMBER NCT01227382.).

Prospective evaluation of the use of fully covered self-expanding metal stents for EUS-guided transmural drainage of pancreatic pseudocysts

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Therapeutic ERCP in the management of pancreatitis in children

BACKGROUND The use of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP) is increasing in the management of pancreatobiliary diseases in children. METHODS Over a 32-month period, we performed 34 ERCP procedures for the treatment of pancreatitis in 22 children at two university hospitals. Demographics and clinical data and ERCP findings were documented. Clinical status was assessed 6 months before the first ERCP and 6 months after the last ERCP, according to general condition, severity and frequency of pain, and health care encounters (emergency department visits, clinic visits, and hospital admissions related to the pancreatitis). RESULTS Mean age of the patients was 10.7 years (range 1.5 to 17 years). Abdominal pain was the main presenting symptoms with hyperamylasemia and hyperlipasemia. Clinical diagnoses included acute pancreatitis (6), recurrent pancreatitis (5), and chronic pancreatitis (11). The mean follow-up was 16.4 months. Nine patients had sphincter manometry, with abnormal results leading to biliary sphincterotomy in 4. Fifteen patients underwent a total of 23 therapeutic ERCP procedures unrelated to sphincter dysfunction. There were 2 complications of 34 procedures (6%), both being mild pancreatitis after sphincter manometry. There were no deaths. There was a significant reduction in frequency (p < 0.01) and severity of pain (p < 0.01) after intervention. Patients without pancreatographic changes of chronic pancreatitis had the most marked clinical improvement (p < 0.05). In those with ductal changes of chronic pancreatitis, clinical improvement was not predicted by the extent of ductal changes. There was a significant decrease in health care encounters (p < 0.05) and improvement in general condition (p < 0.01) after endoscopic therapy, especially in those with a normal pancreatogram. CONCLUSIONS Therapeutic ERCP is safe in pediatric patients with pancreatitis. Significant clinical improvement is achieved in patients with biliary or pancreatic stone disease. Prospective studies with long-term follow-up are needed to determine the impact of endoscopic therapy in patients with chronic pancreatitis and sphincter of Oddi dysfunction.

Rapid-sequence endoscopic management of posttransplant anastomotic biliary strictures

BACKGROUND Post-liver-transplant anastomotic biliary strictures generally have been managed through ERCP with gradual balloon dilation and placement of multiple stents over an extended period of time. OBJECTIVE Our purpose was to evaluate the long-term outcome of rapid sequence dilation and to shorten the duration of stenting as a therapy for anastomotic biliary strictures. DESIGN Prospective case series. SETTING Academic tertiary referral center. INTERVENTIONS ERCP with rapid-sequence balloon dilation of post-liver-transplant anastomotic biliary strictures followed by stenting with multiple stents over a short time period. MAIN OUTCOME MEASUREMENT Long-term anastomotic stricture resolution. RESULTS Thirty-eight patients were prospectively enrolled into a standardized ERCP treatment protocol. The mean number of ERCPs per patient was 3.4 (range 2-6), the mean number of maximum stents inserted was 2.5 (range 1-6), and the mean total stenting period was 107 days (range 20-198 days); the mean follow-up time from completion of the endoscopic therapy was 360 days (range 140-1347 days). Long-term stricture resolution was achieved in 33 of the 38 (87%) patients. LIMITATIONS Lack of control group, relatively small patient population. CONCLUSIONS Accelerated dilation and shorter total length of stenting leads to long-term success in the majority of patients with post-liver-transplant anastomotic biliary strictures.

Spiral enteroscopy: prospective U.S. multicenter study in patients with small-bowel disorders

BACKGROUND The performance characteristics of spiral enteroscopy have not been well-described. OBJECTIVE To determine the technical performance, diagnostic and therapeutic yields, and safety of oral spiral enteroscopy in patients with suspected or established small-bowel pathology. DESIGN Prospective, multicenter, cohort study, with centralized database. SETTING Ten U.S. tertiary-care medical centers. PATIENTS This study involved 148 participants, of whom 101 were referred for obscure bleeding. All participants referred for antegrade deep enteroscopy were considered eligible. INTERVENTION Spiral enteroscopy. MAIN OUTCOME MEASUREMENTS Examination duration, depth of insertion, spiral enteroscopy findings, mucosal assessment upon withdrawal, and patient symptom assessment (day 1 and day 7 after the procedure). RESULTS Spiral enteroscopy was successful in 93% of patients, with a median depth of insertion beyond the angle of Treitz of 250 cm (range 10-600 cm). The mean (± standard deviation) total procedure time was 45.0 ± 16.2 minutes for all procedures, and 35.4 minutes for diagnostic procedures. The diagnostic yield was 65%, of which 48% revealed more than one abnormality. The most common findings were angiectasias (61.5%), inflammation (7.5%), and neoplasia (6.8%). Argon plasma coagulation ablation accounted for 64% of therapeutic interventions. LIMITATIONS This was not a randomized, controlled trial of deep enteroscopy modalities. CONCLUSION Spiral enteroscopy appears to be safe and effective for evaluation of the small bowel. The procedure duration, depth of insertion, and diagnostic and therapeutic yields compare favorably with previously published data on other deep enteroscopy techniques such as single-balloon and double-balloon enteroscopy. Comparative studies are warranted.

Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system

BACKGROUND Older systems for cholangiopancreatoscopy have demonstrated improved diagnostic and therapeutic abilities over standard ERCP but have shown limited feasibility. The SpyGlass Direct Visualization System addresses many of the shortcomings of the older platforms, but its potential advantages have not been rigorously evaluated. OBJECTIVE To prospectively evaluate the feasibility, clinical efficacy, and safety of the SpyGlass system. DESIGN Prospective cohort study. SETTING Tertiary care center. PATIENTS All patients undergoing cholangiopancreatoscopy at our institution. INTERVENTIONS Cholangiopancreatoscopy with the SpyGlass system. MAIN OUTCOME MEASUREMENTS Procedure success, defined as complete stone clearance for stone cases. For nonstone-related lesions, success was defined when all 3 of the following were met: (1) advancement of the SpyScope to the desired target, (2) adequate visualization, and (3) successful applications of all necessary diagnostic and/or therapeutic maneuvers. RESULTS Overall, SpyGlass was successful in 70 of 75 patients (93.3%). In patients with biliary stones, complete stone clearance was achieved in 24 of 26 patients (92.3%). Cholangioscopy for nonstone-related indications was successful in 43 of 44 patients (97.7%). Pancreatoscopy was attempted in 5 patients and was successful in 3 (60%). The mean total procedure time (standard ERCP plus SpyGlass) was 64.3 minutes, the total SpyGlass time was 27.5 minutes, the mean SpyGlass visualization time was 14.2 minutes, the mean SpyBite sampling time was 12.1 minutes, the mean Spy therapy time was 8.4 minutes, and the mean set-up time was 5 minutes. There were 4 adverse events (4.8%). LIMITATIONS Single-center experience, no comparison group, potential for selection bias. CONCLUSIONS ERCP-guided cholangiopancreatoscopy with the SpyGlass system is technically feasible and can be successfully and safely performed in the vast majority of patients. ( CLINICAL TRIAL REGISTRATION NUMBER NCT00861198.).

Large size balloon dilation of the ampulla after biliary sphincterotomy can facilitate endoscopic extraction of difficult bile duct stones.

Goals Evaluate the efficacy and safety of large size balloon dilation of the biliary orifice after maximal biliary sphincterotomy to facilitate removal of difficult bile duct stones in a Western population. Background Some bile duct stones may be difficult to remove with standard endoscopic retrograde cholangiopancreatography (ERCP) techniques. Even after multiple procedures, and the use of advanced, labor-intense techniques complete stone clearance may be difficult to achieve. Study This is retrospective review of prospectively collected data. Patients who had failed stone extraction with standard balloon technique after maximal biliary sphincterotomy at the index ERCP underwent large size balloon dilation of the biliary orifice to facilitate stone removal. The main outcomes were complete stone clearance and complications. Result Forty-four patients were evaluated. Thirty-one (70%) had a prior failed ERCP in the past. Periampullary diverticulum was present in 13 patients (30%). Complete stone removal was accomplished in 42 patients (95%). In 37 patients (84%), complete stone clearance was accomplished at the index ERCP without the need for mechanical lithotripsy. Three patients (6%) required an additional ERCP and 2 patients (5%) required 2 additional ERCPs to accomplish complete stone removal. Three mild complications occurred (6.8%). None of the patients developed perforation or pancreatitis. Conclusions Large size balloon dilation after biliary sphincterotomy is simple, safe, and highly effective technique that can greatly assist in the management of difficult to extract bile duct stones.

Role of Osmolality of Contrast Media in the Development of Post-ERCP Pancreatitis: A Metanalysis

The role of osmolality of contrast media (CM) in the development of post-ERCP pancreatitis (PEP) is debated. We therefore performed a metanalysis to determine whether osmolality affects the incidence of PEP. A literature search of English-language studies was performed using computerized databases and manual searching of abstracts and article bibliographies. Randomized controlled trials comparing the incidence of PEP associated with high- and low-osmolality contrast media (HOCM, LOCM) were considered. The outcome assessed was clinical pancreatitis as evidenced by both elevation of pancreatic enzymes and pain. Data were analyzed using logistic regression with terms for study and osmolality. Fishers exact test was done to compare PEP rates. Homogeneity between studies was indicated by the nonsignificance of the study effect in the logistic regression model. Logistic regression also indicated no difference in PEP rates between LOCM and HOCM (P=0.399). Comparison of PEP rates in both groups using Fishers exact test did not indicate a difference in any individual study (all P values >0.05). Due to the large variation of study sample sizes, we repeated the analysis by creating three study groups. The effect of osmolality was invariant to how the data were combined. The results of this metanalysis indicate that there is no significant difference between HOCM and LOCM with respect to clinical PEP.