Implementation of endoscopic submucosal dissection in Europe: survey after ten ESD expert training workshops 2009 – 2018

Background and aims Transfer of ESD technique for early gastrointestinal cancer from Japan requires expert-supervised experimental training before unsupervised implementation of clinical ESD. Aims To evaluate unsupervised implementation of ESD-intention-to-treat (-ITT). Methods ESD Workshops (in-vivo porcine model) lasted 3.3 days including one day theory for 177 participants from 135 Western referral centers. A questionnaire was sent to the senior participant of all 135 centers. Design Cross-sectional questionnaire survey. Main outcome measurements Performance, organ distribution, severe adverse events of ESD-ITT. Results Feedback was received from 113 centers (84%), i.e. 73 (54%) ESD centers and 40 centers (30%) with zero ESD; 10 (7%) had published ESD; no feedback from 12 (9%) centers with unknown status. Altogether, 83 centers (61.5%) perform ESD: 21 (16%) had >150 ESD (professional category), 33 (24%) had 31-150 ESD (competent category), and 29 (21.5%) had ≤ 30 ESD (initial learning category). Most implemented ESD centers (91%, 72 of 79) were analyzed: Centers on initial learning (420 ESD) compared to centers with >30 ESD (5676 ESD) performed en-bloc ESD in 64% vs. 84%, hybrid-ESD in 26% vs.11% and piecemeal-EMR in 10% vs. 5.2%. Majority of ESD (66-68%) were in colorectum, overall with low risk (30-day mortality 0.03%, surgical repair 3.5% vs. 1.7%) and satisfactory outcome (oncosurgery 7.4% vs. 5.2%, local recurrence 1.5% vs. 0.3%). Conclusions Beyond guideline recommendations, unsupervised implementation of ESD was successful in colorectum with step-up approach. Now, Western ESD centers have to aim for professional (i.e. >80%) curative ESD

Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid "cushion" for endoscopic resection of colorectal mucosal neoplasms: A prospective multi-center open-label trial

<p>Abstract</p> <p>Background</p> <p>Sodium hyaluronate (SH) solution has been used for submucosal injection in endoscopic resection to create a long-lasting submucosal fluid "cushion". Recently, we proved the usefulness and safety of 0.4% SH solution in endoscopic resection for gastric mucosal tumors. To evaluate the usefulness of 0.4% SH as a submucosal injection solution for colorectal endoscopic resection, we conducted an open-label clinical trial on six referral hospitals in Japan.</p> <p>Methods</p> <p>A prospective multi-center open-label study was designed. A total of 41 patients with 5–20 mm neoplastic lesions localized in the colorectal mucosa at six referral hospitals in Japan in a single year period from December 2002 to November 2003 were enrolled and underwent endoscopic resection with SH. The usefulness of 0.4% SH was assessed by the <it>en bloc </it>complete resection and the formation and maintenance of mucosal lesion-lifting during endoscopic resection. Safety was evaluated by analyzing adverse events during the study period.</p> <p>Results</p> <p>The usefulness rate was high (82.5%; 33/40). The following secondary outcome measures were noted: 1) steepness of mucosal lesion-lifting, 75.0% (30/40); 2) intraoperative complications, 10.0% (4/40); 3) time required for mucosal resection, 6.7 min; 4) volume of submucosal injection, 6.8 mL and 5) ease of mucosal resection, 87.5% (35/40). Two adverse events of bleeding potentially related to 0.4% SH were reported.</p> <p>Conclusion</p> <p>Using 0.4% SH solution enabled sufficient lifting of a colorectal intramucosal lesion during endoscopic resection, reducing the need for additional injections and the risk of perforation. Therefore, 0.4% SH may contribute to the reduction of complications and serve as a promising submucosal injection solution due to its potentially superior safety in comparison to normal saline solution.</p

Early Neoplasias of the Gastrointestinal TractEndoscopic Diagnosis and Therapeutic Decisions /

XIII, 270 p. 172 illus., 127 illus. in color.onli