Endoscopic full-thickness resection of T1 colorectal cancers: a retrospective analysis from a multicenter Dutch eFTR registry.

BACKGROUND: Complete endoscopic resection and accurate histological evaluation for T1 colorectal cancer (CRC) are critical in determining subsequent treatment. Endoscopic full-thickness resection (eFTR) is a new treatment option for T1 CRC < 2 cm. We aimed to report clinical outcomes and short-term results. METHODS: Consecutive eFTR procedures for T1 CRC, prospectively recorded in our national registry between November 2015 and April 2020, were retrospectively analyzed. Primary outcomes were technical success and R0 resection. Secondary outcomes were histological risk assessment, curative resection, adverse events, and short-term outcomes. RESULTS: We included 330 procedures: 132 primary resections and 198 secondary scar resections after incomplete T1 CRC resection. Overall technical success, R0 resection, and curative resection rates were 87.0 % (95 % confidence interval [CI] 82.7 %-90.3 %), 85.6 % (95 %CI 81.2 %-89.2 %), and 60.3 % (95 %CI 54.7 %-65.7 %). Curative resection rate was 23.7 % (95 %CI 15.9 %-33.6 %) for primary resection of T1 CRC and 60.8 % (95 %CI 50.4 %-70.4 %) after excluding deep submucosal invasion as a risk factor. Risk stratification was possible in 99.3 %. The severe adverse event rate was 2.2 %. Additional oncological surgery was performed in 49/320 (15.3 %), with residual cancer in 11/49 (22.4 %). Endoscopic follow-up was available in 200/242 (82.6 %), with a median of 4 months and residual cancer in 1 (0.5 %) following an incomplete resection. CONCLUSIONS: eFTR is relatively safe and effective for resection of small T1 CRC, both as primary and secondary treatment. eFTR can expand endoscopic treatment options for T1 CRC and could help to reduce surgical overtreatment. Future studies should focus on long-term outcomes.

[Experiences with endoscopic full-thickness resection of complex colorectal lesions]. / Ervaringen met endoscopische 'full-thickness'-resectie van colorectale afwijkingen.

Endoscopic full-thickness resection (eFTR) is a minimally invasive resection technique that allows definite diagnosis and treatment for complex colorectal lesions unsuitable to conventional endoscopic resection. With the advantage of enabling a transmural resection, eFTR offers an alternative to radical surgery. Since the introduction of the full-thickness resection device in 2015, a nationwide prospective registry of consecutive eFTR procedures for all indications was initiated in the Netherlands, aiming to monitor patient outcomes and increase further knowledge on its clinical applicability and safety. Data show that eFTR is clinically feasible and relatively safe for complex colorectal lesions. Furthermore, eFTR is gaining interest as a diagnostic and therapeutic treatment option for T1 colorectal cancer.

Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial.

BACKGROUND: Endoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleeding, occurring in 7% overall and in approximately 10% of polyps ≥ 2 cm in the proximal colon. Previous research has suggested that prophylactic clipping of the mucosal defect after EMR may reduce the incidence of delayed bleeding in polyps with a high bleeding risk. METHODS: The CLIPPER trial is a multicenter, parallel-group, single blinded, randomized controlled superiority study. A total of 356 patients undergoing EMR for large (≥ 2 cm) non-pedunculated polyps in the proximal colon will be included and randomized to the clip group or the control group. Prophylactic clipping will be performed in the intervention group to close the resection defect after the EMR with a distance of < 1 cm between the clips. Primary outcome is delayed bleeding within 30 days after EMR. Secondary outcomes are recurrent or residual polyps and clip artifacts during surveillance colonoscopy after 6 months, as well as cost-effectiveness of prophylactic clipping and severity of delayed bleeding. DISCUSSION: The CLIPPER trial is a pragmatic study performed in the Netherlands and is powered to determine the real-time efficacy and cost-effectiveness of prophylactic clipping after EMR of proximal colon polyps ≥ 2 cm in the Netherlands. This study will also generate new data on the achievability of complete closure and the effects of clip placement on scar surveillance after EMR, in order to further promote the debate on the role of prophylactic clipping in everyday clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03309683 . Registered on 13 October 2017. Start recruitment: 05 March 2018. Planned completion of recruitment: 31 August 2021.

Endoscopic full-thickness resection (eFTR) of colorectal lesions: results from the Dutch colorectal eFTR registry.

BACKGROUND: Endoscopic full-thickness resection (eFTR) is a minimally invasive resection technique that allows definite diagnosis and treatment for complex colorectal lesions ≤ 30 mm unsuitable for conventional endoscopic resection. This study reports clinical outcomes from the Dutch colorectal eFTR registry. METHODS: Consecutive patients undergoing eFTR in 20 hospitals were prospectively included. The primary outcome was technical success, defined as macroscopic complete en bloc resection. Secondary outcomes were: clinical success, defined as tumor-free resection margins (R0 resection); full-thickness resection rate; and adverse events. RESULTS : Between July 2015 and October 2018, 367 procedures were included. Indications were difficult polyps (non-lifting sign and/or difficult location; n = 133), primary resection of suspected T1 colorectal cancer (CRC; n = 71), re-resection after incomplete resection of T1 CRC (n = 150), and subepithelial tumors (n = 13). Technical success was achieved in 308 procedures (83.9 %). In 21 procedures (5.7 %), eFTR was not performed because the lesion could not be reached or retracted into the cap. In the remaining 346 procedures, R0 resection was achieved in 285 (82.4 %) and full-thickness resection in 288 (83.2 %). The median diameter of resected specimens was 23 mm. Overall adverse event rate was 9.3 % (n = 34/367): 10 patients (2.7 %) required emergency surgery for five delayed and two immediate perforations and three cases of appendicitis. CONCLUSION : eFTR is an effective and relatively safe en bloc resection technique for complex colorectal lesions with the potential to avoid surgery. Further studies assessing the role of eFTR in early CRC treatment with long-term outcomes are needed.

Erratum: Endoscopic full-thickness resection in the colorectum: a single-center case series evaluating indication, efficacy and safety.

[This corrects the article DOI: 10.1055/a-0672-1138.].

Endoscopic full-thickness resection in the colorectum: a single-center case series evaluating indication, efficacy and safety.

Background and study aims Endoscopic full-thickness resection (eFTR) allows en-bloc and transmural resection of colorectal lesions for which other advanced endoscopic techniques are unsuitable. We present our experience with a novel "clip first, cut later" eFTR-device and evaluate its indications, efficacy and safety. Patients and methods From July 2015 through October 2017, 51 eFTR-procedures were performed in 48 patients. Technical success and R0-resection rates were prospectively recorded and retrospectively analyzed. Results Indications for eFTR were non-lifting adenoma (n = 19), primary resection of malignant lesion (n = 2), resection of scar tissue after incomplete endoscopic resection of low-risk T1 colorectal carcinoma (n = 26), adenoma involving a diverticulum (n = 2) and neuroendocrine tumor (n = 2). Two lesions were treated by combining endoscopic mucosal resection and eFTR. Technical success was achieved in 45 of 51 procedures (88 %). Histopathology confirmed full-thickness resection in 43 of 50 specimens (86 %) and radical resection (R0) in 40 procedures (80 %). eFTR-specimens, obtained for indeterminate previous T1 colorectal carcinoma resection, were free of residual carcinoma in 25 of 26 cases (96 %). In six patients (13 %) a total of eight adverse events occurred within 30 days after eFTR. One perforation occurred, which was corrected endoscopically. No emergency surgery was necessary. Conclusion In this study eFTR appears to be safe and effective for the resection of colorectal lesions. Technical success, R0-resection and major adverse events rate were reasonable and comparable with eFTR data reported elsewhere. Mean specimen diameter (23 mm) limits its use to relatively small lesions. A clinical algorithm for eFTR case selection is proposed. eFTR ensured local radical excision where other endoscopic techniques did not suffice and reduced the need for surgery in selected cases.

[Endoscopic full-thickness resection of colorectal polyps]. / Endoscopische 'full-thickness'-resectie van colorectale poliepen.

With the introduction of a national screening program for colorectal cancer, an increasing number of colorectal neoplasias, including low-risk T1-carcinomas, is identified and resected endoscopically. Existing techniques for endoscopic resection do not always suffice. Currently, surgery is the only available option in these cases. Endoscopic full-thickness resection (eFTR) is a minimally invasive alternative to surgery for resection of non-lifting adenomas, adenomas in difficult-to-reach locations - such as the diverticulum - and for ensuring radical endoscopic resection in T1-carcinomas. The first results of research involving this new technique are promising. Prospective studies comparing the efficacy and safety of eFTR versus surgical resection are indicated.

Tenofovir-induced Fanconi syndrome and osteomalacia in two HIV-infected patients: role of intracellular tenofovir diphosphate levels and review of the literature.

We present 2 human immunodeficiency virus-infected patients with tenofovir disoproxil fumarate-induced Fanconi syndrome, leading to osteomalacia. Intracellular tenofovir diphosphate levels were measured in 1 patient and were found to be very high, with plasma tenofovir levels just slightly elevated. Fibroblast growth factor-23, a phosphaturic hormone, was decreased in both patients and is therefore unlikely to have a pathophysiological role in this pathology. The different potential factors contributing to the development of tenofovir-related kidney proximal tubular dysfunction are discussed and the data presented may help to further elucidate its pathogenesis.