Feasibility of nonradiation EUS-based ERCP in patients with uncomplicated choledocholithiasis (with video).

BACKGROUND AND AIMS: ERCP inherently involves radiation exposure. Nonradiation ERCP has been described in pregnancy. Theoretically, the same techniques could be applied to the general population. We prospectively assessed the feasibility of nonradiation, EUS-based ERCP in nonpregnant patients with choledocholithiasis. METHODS: Consecutive patients referred for ERCP for choledocholithiasis were recruited over a 1-year period. Patients providing study consent underwent the following procedural protocol. First, EUS was performed to verify the presence, size, and number of stones. Second, biliary cannulation was attempted without fluoroscopy for a maximum of 10 minutes. Selective cannulation was based on deep insertion with visible bile in the catheter on aspiration. Third, for stone removal, sphincterotomy was performed and stones were removed using a basket or balloon. The number of stones exiting the papilla was matched to the number seen on EUS. Finally, once the duct was deemed clear by the endoscopist, a final occlusion cholangiogram and ductal sweep served as the reference standard for confirmation of stone clearance. RESULTS: Nonradiation ERCP was attempted in 31 patients. Cannulation without fluoroscopy was successful in 26 patients (84%). Complete stone removal without fluoroscopy was achieved in all 26 of these cases. The 5 patients with failed nonfluoroscopic cannulation required double guidewire (n = 2) or precut papillotomy (n = 3) for deep biliary access and subsequent stone clearance. One patient who required precut papillotomy for access developed moderate post-ERCP pancreatitis (3%). CONCLUSIONS: Nonradiation, EUS-based ERCP for uncomplicated choledocholithiasis appears to be successful and safe. (Clinical trial registration number: NCT01678391.).

Suck-ligate-unroof-biopsy by using a detachable 20-mm loop for the diagnosis and therapy of small subepithelial tumors (with video).

BACKGROUND: The diagnosis and therapy of subepithelial tumors (SETs) can be challenging. OBJECTIVE: Proof-of-concept evaluation of the suck-ligate-unroof-biopsy (SLUB) technique for small (<2 cm), non-pedunculated SETs. DESIGN: Pilot feasibility study. SETTING: Tertiary-care referral center. PATIENTS: Twenty-three patients (median age 60 years) meeting the inclusion criteria after preliminary EUS. INTERVENTION: SET ligation was performed with a detachable 20-mm loop deployed through an 18-mm diameter, soft, oblique, transparent, cap attachment. The SLUB technique comprised (1) suction to draw the SET into the cap; (2) ligation below the SET, confirmation by repeat EUS; (3) unroofing of the overlying mucosa with a needle-knife; and (4) biopsy specimens taken from the exposed tumor. MAIN OUTCOME MEASUREMENTS: Technical success, histology and/or immunohistochemistry yield, adverse events, completeness of resection. RESULTS: SLUB was attempted on 24 SETs and was technically successful in all. Location was the stomach (n = 19), small bowel (n = 1), colon (n = 2), and rectum (n = 2). Median size by EUS was 10 mm (range 6-15 mm). Biopsy specimens provided an immunohistologic diagnosis in all cases: GI stromal tumor (n = 5), leiomyoma (n = 8), carcinoid tumor (n = 5), Vanek's tumor (n = 2), granuloma (n =1), and pancreatic heterotopia (n = 3). Follow-up endoscopy and EUS in 13 patients showed well-healed scars with no residual tumor, including all 9 patients with premalignant neoplastic lesions. The only adverse event was self-limited pain in 2 patients. LIMITATIONS: Single center, single operator, small sample size. CONCLUSIONS: Loop ligation of small, non-pedunculated SETs is feasible by using a cap attachment for suction. Unroofing after ligation is safe and provides sufficient tissue for immunohistochemistry. Ligation combined with unroofing appears to lead to complete ablation by ischemia and tumor enucleation.

"Underwater" EMR of sporadic laterally spreading nonampullary duodenal adenomas (with video).

BACKGROUND: EMR for the treatment of duodenal adenomas is challenging due to a thin wall and rich vascularity. OBJECTIVE: To evaluate a novel technique of "underwater" EMR without prior submucosal injection for the removal of large (≥2 cm) laterally spreading nonampullary duodenal adenomas. DESIGN: Prospective, observational study. SETTING: Tertiary academic referral center. PATIENTS: Twelve patients (median age, 60 years) meeting the inclusion criteria. INTERVENTIONS: Piecemeal EMR technique after sterile water submersion when using a double-channel endoscope. MAIN OUTCOME MEASUREMENTS: Technical success, adverse events, completeness of resection on follow-up endoscopy. RESULTS: Median adenoma size was 35 mm (25% greater than one-half circumference, 50% equal to one-third to one-half circumference, and 25% less than one-third circumference). Median procedure time was 65 minutes (range, 32-151). Final histology was tubular adenoma (7), tubulovillous adenoma (1), villous adenoma (3), and high-grade dysplasia (1). Eleven patients (92%) met the primary endpoint (technical success) and all patients met the secondary endpoint (completeness of resection). Median interval until follow-up endoscopy was 16 weeks (range, 11-56). Adverse events were as follows: delayed bleeding (3 patients, of whom 2 required transfusions), water intoxication syndrome manifested by altered mental status and hyponatremia (1), and stricture formation (1) that responded to balloon dilation. No perforation or postresection abdominal pain was found. LIMITATIONS: Single operator, single center, small sample size, limited follow-up. CONCLUSION: Underwater EMR for large sessile duodenal adenomas has high success rates for complete removal. The risk of delayed bleeding is significant, and precautions are needed when infusing a large volume of fluid into the GI tract.

Retract-ligate-unroof-biopsy: a novel approach to the diagnosis and therapy of large nonpedunculated stromal tumors (with video).

BACKGROUND: We report a novel technique of retract-ligate-unroof-biopsy (RLUB) for the diagnosis and treatment of large nonpedunculated upper GI stromal tumors originating from the muscularis propria. OBJECTIVE: Proof-of-concept evaluation of the RLUB technique. DESIGN: Pilot and feasibility study. SETTING: Tertiary care center. PATIENTS: Sixteen patients (median age 71 years) fulfilling the following inclusion criteria: poor surgical candidates with lesions that are broad based with a benign appearance, originating from the muscularis propria, size 2 cm or larger. INTERVENTIONS: A double-channel endoscope was used to simultaneously retract the stromal tumor while advancing an endoloop beyond the tumor for ligation. The overlying tissue was incised ("unroofed") to expose and partially enucleate the tumor, and multiple biopsy samples were obtained. After unroofing, an additional endoloop was placed below the previous one by using the loop-over-loop technique to reinforce enucleation and ischemic ablation. MAIN OUTCOME MEASUREMENTS: Successful ligation, immunohistochemistry and mitotic index yield, therapeutic ablation, adverse events. RESULTS: Technical success was achieved in 13 of 16 patients (81%). Immunohistology of biopsy specimens: GI stromal tumor (n = 10), leiomyoma (n = 3). Twelve of 13 patients (92%) with follow-up (median 22 weeks, range 1-82.5 weeks) had confirmed tumor ablation by endoscopy and EUS. One patient with partial resolution was re-treated, but was subsequently lost to follow-up. Delayed bleeding occurred in 2 patients that required hospitalization and blood transfusions, both successfully controlled with repeat endolooping. One patient reported transient pain. LIMITATIONS: Single center, single operator, small sample size. CONCLUSIONS: The RLUB technique is feasible as a platform for full-thickness treatment of stromal tumors. Limitations encountered included technical challenges and delayed bleeding. Further developmental work is needed.

Similar risk of renal events among patients treated with tenofovir or entecavir for chronic hepatitis B.

BACKGROUND & AIMS: Tenofovir is a nucleotide reverse-transcriptase inhibitor approved for treatment of human immunodeficiency virus infection, as well as chronic hepatitis B (CHB). We evaluated nephrotoxicity among patients with CHB treated with tenofovir. METHODS: We performed a community-based, retrospective cohort study of 80 patients with CHB who received tenofovir, alone or in a combination regimen; they were matched for age and sex with 80 CHB patients who received only entecavir. Incidences of serum creatinine (SCr) increase ≥0.2 mg/dL and new SCr levels of 1.5, 2.0, or 2.5 mg/dL were assessed. Patients with an estimated glomerular filtration rate (eGFR) <60 mL/min, calculated using the Modification of Diet in Renal Disease or Cockcroft-Gault formula, or who had ≥20% decrease in eGFR were also recorded. RESULTS: More patients given entecavir had increases in SCr ≥2.5 mg/dL (1 vs 6; P = .053), whereas more patients given tenofovir had a new Cockcroft-Gault eGFR of <60 mL/min (15 vs 6; P = .022) and at least 1 dose adjustment (13 vs 4; P = .021). By multivariate analysis, the only significant factors associated with an increase in SCr were a history of organ transplantation (adjusted odds ratio, 6.740; 95% confidence interval, 1.799-28.250; P = .005) and pre-existing renal insufficiency (adjusted odds ratio, 10.960; 95% confidence interval, 2.419-48.850; P = .002). No factors, including therapy assignment, were associated with a new eGFR <60 mL/min. CONCLUSIONS: Markers of renal function indicated that patients who received tenofovir were no more likely to have changes in renal function than patients treated with entecavir. History of transplant and pre-existing renal insufficiency were the only factors independently associated with increases in SCr.