INTRODUCTION:Preclinical, epidemiological, and small clinical studies suggest that green tea extract (GTE) and its major active component epigallocatechingallate (EGCG) exhibit antineoplastic effects in the colorectum.METHODS:A randomized, double-blind trial of GTE standardized to 150 mg of EGCG b.i.d. vs placebo over 3 years was conducted to prevent colorectal adenomas (n = 1,001 with colon adenomas enrolled, 40 German centers). Randomization (1:1, n = 879) was performed after a 4-week run-in with GTE for safety assessment. The primary end point was the presence of adenoma/colorectal cancer at the follow-up colonoscopy 3 years after randomization.RESULTS:The safety profile of GTE was favorable with no major differences in adverse events between the 2 well-balanced groups. Adenoma rate in the modified intention-to-treat set (all randomized participants [intention-to-treat population] and a follow-up colonoscopy 26–44 months after randomization; n = 632) was 55.7% in the placebo and 51.1% in the GTE groups. This 4.6% difference was not statistically significant (adjusted relative risk 0.905; P = 0.1613). The respective figures for the per-protocol population were 54.3% (151/278) in the placebo group and 48.3% (129/267) in the GTE group, indicating a slightly lower adenoma rate in the GTE group, which was not significant (adjusted relative risk 0.883; P = 0.1169).DISCUSSION:GTE was well tolerated, but there was no statistically significant difference in the adenoma rate between the GTE and the placebo groups in the whole study population.

Background and study aims: Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are established techniques for the treatment of superficial gastrointestinal neoplasia. Limitations of EMR are the low en bloc resection rates for larger lesions resulting in frequent recurrences. Major disadvantages of ESD are technical difficulty and long procedure times. Here, we evaluated technical feasibility and safety of newly designed devices to perform en bloc resection of lesions sized between ca. 20-40 mm. The method will be referred to as Endoscopic Submucosal Resection (ESR). Patients and methods: This case series included 93 lesions from different localizations (11x stomach, 25x colon, 57x rectum) with a median size of 29 (10-70) mm. ESR was carried out with two novel instruments for circumferential mucosal incision and for deep submucosal resection. Results: Resection by ESR was feasible in all cases. En bloc and R0 rates were insufficient when ESR was attempted without prior circumferential mucosal incision. However, en bloc and R0 resection rates were 70% and 63%, respectively when mucosal incision was done before application of the device for submucosal resection. We observed 3 complications (2 delayed bleedings, one microperforation) but no case of emergency surgery and no 30-day mortality. Conclusions: The series demonstrates feasibility and excellent safety of ESR using two novel devices for en bloc resection of early gastrointestinal neoplasia. The technique holds the promise of relative technical ease combined with high efficacy.

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Accurate histopathology is the mainstay for reliable classification of resected early colorectal cancer lesions in terms of potential risk of lymph node metastasis. In particular, thickness of resected submucosa is important in cases of submucosal invasive cancer. Nevertheless, little is known about the quality and thickness of submucosal tissue obtained using different endoscopic resection techniques. In this small pilot study, we performed morphometric analysis of submucosal thickness in specimens obtained from right-sided colorectal lesions using endoscopic mucosal resection (EMR) versus endoscopic submucosal resection (ESD). Comparative measurements showed significant differences in submucosal area ≥ 1000 μm and minimum submucosal thickness per tissue section analyzed (EMR vs. ESD: 91.2 % ± 6.6 vs. 47.1 % ± 10.6, P = 0.018; 933.7 µm ± 125.1 vs. 319.0 µm ± 123.6, P = 0.009). In contrast, no significant differences were observed in variation coefficient and mean maximum submucosal thickness. Thus, unexpectedly, in this small retrospective pilot study, specimens obtained using EMR had a better preserved submucosal layer than those obtained using ESD – possibly due to the different methods of specimen acquisition. The findings should be kept in mind when attempting to resect lesions suspicious for submucosal invasive cancer.