Song, Louis M. Wong Kee

Abstract Background and aims Endoscopic resections are associated with bleeding and perforation and may be managed with through-the-scope (TTS) clips, over-the-scope clips and endoscopic suturing. The aim of this preclinical study was to compare technical success of closure using a novel TTS tissue helix tack and suture device (X-Tack) to TTS clips in a porcine model. Materials and methods Four subjects underwent 40 mucosal resections, diameter range 25–50 mm, in the stomach (n = 24) and colon (n = 16). Closures were randomized to X-Tack (n = 24) or clip (n = 16). Animals underwent weekly endoscopic follow-up for 4 weeks. Results Technical closure with X-Tack was successful in 24 of 24 (100 %) cases and with clips in 13 of 16 cases (81.3 %) (P = 0.0001). One colonic perforation occurred and was successfully managed using X-Tack. The rate of healing was not statistically different between the groups, and all sites healed at 4 weeks including the perforation and were confirmed by histology. Conclusions Compared to TTS clip, X-Tack is superior for effecting large mucosal defect closure, including durable sealing of full-thickness perforation. There was no difference in rate of healing between devices.

Abstract Polyphenon E (Poly E) is a green tea polyphenol preparation whose most active component is epigallocatechin gallate (EGCG). We studied the cancer preventive efficacy and safety of Poly E in subjects with rectal aberrant crypt foci (ACF), which represent putative precursors of colorectal cancers. Eligible subjects had prior colorectal advanced adenomas or cancers, and had ≥5 rectal ACF at a preregistration chromoendoscopy. Subjects (N = 39) were randomized to 6 months of oral Poly E (780 mg EGCG) daily or placebo. Baseline characteristics were similar by treatment arm (all P >0.41); 32 of 39 (82%) subjects completed 6 months of treatment. The primary endpoint was percent reduction in rectal ACF at chromoendoscopy comparing before and after treatment. Among 32 subjects (15 Poly E, 17 placebo), percent change in rectal ACF number (baseline vs. 6 months) did not differ significantly between study arms (3.7% difference of means; P = 0.28); total ACF burden was also similar (−2.3% difference of means; P = 0.83). Adenoma recurrence rates at 6 months were similar by arm (P > 0.35). Total drug received did not differ significantly by study arm; 31 (79%) subjects received ≥70% of prescribed Poly E. Poly E was well tolerated and adverse events (AE) did not differ significantly by arm. One subject on placebo had two grade 3 AEs; one subject had grade 2 hepatic transaminase elevations attributed to treatment. In conclusion, Poly E for 6 months did not significantly reduce rectal ACF number relative to placebo. Poly E was well tolerated and without significant toxicity at the dose studied. Prevention Relevance: We report a chemoprevention trial of polyphenon E in subjects at high risk of colorectal cancer. The results show that polyphenon E was well tolerated, but did not significantly reduce the number of rectal aberrant crypt foci, a surrogate endpoint biomarker of colorectal cancer.

Abstract Background Endoscopic cyanoacrylate (glue) injection of fundal varices may result in life-threatening embolic adverse events through spontaneous gastrorenal shunts (GRSs). Balloon-occluded retrograde transvenous occlusion (BRTOcc) of GRSs during cyanoacrylate injection may prevent serious systemic glue embolization through the shunt. This study aimed to evaluate the efficacy and safety of a combined endoscopic–interventional radiologic (BRTOcc) approach for the treatment of bleeding fundal varices. Methods We retrospectively analysed the data of patients who underwent the combined procedure for acutely bleeding fundal varices between January 2010 and April 2018. Data were extracted for patient demographics, clinical and endoscopic findings, technical details, and adverse events of the endoscopic–BRTOcc approach and patient outcomes. Results We identified 30 patients (13 [43.3%] women; median age 58 [range, 25–92] years) with gastroesophageal varices type 2 (53.3%, 16/30) and isolated gastric varices type 1 (46.7%, 14/30) per Sarin classification, and median clinical and endoscopic follow-up of 151 (range, 4–2,513) days and 98 (range, 3–2,373) days, respectively. The median volume of octyl-cyanoacrylate: Lipiodol injected was 7 (range, 4–22) mL. Procedure-related adverse events occurred in three (10.0%) patients, including transient fever, non-life-threatening pulmonary glue embolism, and an injection-site ulcer bleed. Complete gastric variceal obturation was achieved in 18 of 21 patients (85.7%) at endoscopic follow-up. Delayed variceal rebleeding was confirmed in one patient (3.3%) and suspected in two patients (6.7%). Although no procedure-related deaths occurred, the overall mortality rate was 46.7%, primarily from liver-disease progression and co-morbidities. Conclusion The combined endoscopic–BRTOcc procedure is a relatively safe and effective technique for bleeding fundal varices, with a high rate of variceal obturation and a low rate of serious adverse events.

Abstract Difluoromethylornithine (DFMO), an inhibitor of polyamine synthesis, was shown to act synergistically with a NSAID for chemoprevention of colorectal neoplasia. We determined the efficacy and safety of DFMO plus aspirin for prevention of colorectal adenomas and regression of rectal aberrant crypt foci (ACF) in patients with prior advanced adenomas or cancer. A double-blinded, placebo-controlled trial was performed in 104 subjects (age 46–83) randomized (1:1) to receive daily DFMO (500 mg orally) plus aspirin (325 mg) or matched placebos for one year. All polyps were removed at baseline. Adenoma number (primary endpoint) and rectal ACF (index cluster and total) were evaluated at a one year colonoscopy. ACF were identified by chromoendoscopy. Toxicity was monitored, including audiometry. Eighty-seven subjects were evaluable for adenomas or ACF modulation (n = 62). At one year of treatment, adenomas were detected in 16 (38.1%) subjects in the DFMO plus aspirin arm (n = 42) versus 18 (40.9%) in the placebo arm (n = 44; P = 0.790); advanced adenomas were similar (n = 3/arm). DFMO plus aspirin was associated with a statistically significant reduction in the median number of rectal ACF compared with placebo (P = 0.036). Total rectal ACF burden was also reduced in the treatment versus the placebo arm relative to baseline (74% vs. 45%, P = 0.020). No increase in adverse events, including ototoxicity, was observed in the treatment versus placebo arms. While adenoma recurrence was not significantly reduced by one year of DFMO plus aspirin, the drug combination significantly reduced rectal ACF number consistent with a chemopreventive effect.

Abstract Background and study aims There are limited published data on endoscopic removal of colorectal polyps by endoscopic mucosal resection (EMR) and endoscopic mucosal dissection (ESD) in patients with inflammatory bowel disease (IBD). Patients and methods We performed a retrospective review of patients with colonic IBD and colonic polyps >10mm who underwent EMR and/or ESD at our institution between January 1, 2012 and June 31, 2016. Results Ninety-seven patients with pathology-confirmed IBD (median disease duration 16 years) were included. Mild or moderate active colitis (in background biopsies) was seen in 85 %. Of the total 124 polyps, location was ascending colon in 44 %, transverse in 15 % and sigmoid in 18.5 %; of the total, 55 % were < 20 mm and 45 % were ≥20mm in maximal diameter. Using the Paris classification, 56 % of polyps were polypoid sessile (Is) polyps, while 38 % were non-polypoid (IIa, IIb, IIc). EMR was used in 118 polyps, three required ESD, and three by combined EMR-ESD. Seventy-two percent were resected en-bloc; 28 % underwent piecemeal resection. Histology included low-grade dysplasia in 75, serrated adenoma in 31, and tubular adenoma in 14 polyps. Chromoendoscopy was used in 33 (26.6 %). Adverse events occurred in three patients. Colectomy was performed in 11 patients within 12 months. Recurrence was seen in 20 polyps, 11 of which were successfully resected en-bloc using EMR. Polyps ≥ 20 mm and polyps treated with APC were found to have a statistically significantly higher risk of recurrence. Conclusion This study demonstrates the efficacy and safety of endoscopic resection of large polyps in patients with IBD, making them effective alternatives to colectomy.

Abstract Background and study aim The role of esophageal overtubes in upper gastrointestinal endoscopic suturing is unknown. This study aimed to determine whether overtube use was associated with technical success or adverse events. Patients and methods A retrospective review of consecutive patients who underwent endoscopic suturing for various indications was performed. Results A total of 719 patients underwent endoscopic suturing for various indications, including endoscopic bariatric procedures in 262, stent fixation in 258, defect closure in 190, and hemostasis in nine. An overtube was used in 186 procedures (25.9 %). Technical success was achieved in all cases. Minor mucosal trauma occurred in 15 cases (8.1 %) with use of an overtube, and none without an overtube (P < 0.0001). No full-thickness esophageal perforation or hemorrhage related to overtube use or the suturing device occurred. Conclusions Endoscopic suturing can be performed safely for a variety of indications, including endoscopic bariatric procedures, defect repair, and stent fixation without an esophageal overtube. Minor esophageal mucosal trauma and equipment cost are increased when an overtube is used.