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

Endoscopy ◽  
2021 ◽  
Author(s):  
Liselotte W. Zwager ◽  
Barbara Bastiaansen ◽  
Bas van der Spek ◽  
Dimitri Heine ◽  
Ramon Michel Schreuder ◽  
...  

Background and study aims: Complete endoscopic resection and accurate histological evaluation for T1 colorectal cancer (CRC) is critical to determine subsequent treatment. Endoscopic Full-Thickness Resection (eFTR) is a new treatment option for T1 CRC <2cm. We aim to report clinical outcomes and short-term results. Patients and methods: Consecutive eFTR procedures for T1 CRC, prospectively recorded in our national registry between November 2015 and April 2020, were retrospectively analysed. Primary outcomes were technical success and R0 resection. Secondary outcomes were histological risk-assessment, curative resections, 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% 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 for primary resected T1 CRC was 23.7% (95% CI [15.9 – 33.6%]) and 60.8% (95% CI [50.4 – 70.4%]) after excluding deep submucosal invasion as risk-factor. Risk-stratification was possible in 99.3%. Severe adverse event rates was 2.2%. Additional oncologic 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 a relatively safe and effective method to resect 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.

Endoscopy ◽  
2020 ◽  
Vol 52 (11) ◽  
pp. 1014-1023 ◽  
Author(s):  
Liselotte W. Zwager ◽  
Barbara A. J. Bastiaansen ◽  
Maxime E. S. Bronzwaer ◽  
Bas W. van der Spek ◽  
G. Dimitri N. Heine ◽  
...  

Abstract 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.


Author(s):  
Přemysl Falt ◽  
Jana Zapletalová ◽  
Ondřej Urban

AbstractEndoscopic full-thickness resection (FTR) is a novel technique of endoscopic treatment of colorectal neoplastic lesions not suitable for endoscopic polypectomy or mucosal resection. FTR appears to be a reasonable alternative to technically demanding endoscopic submucosal dissection (ESD) for lesions ≤ 30 mm. However, comparison between FTR and ESD has not been published yet and their mutual positioning in the treatment algorithm is still unclear. The purpose of the analysis was to evaluate efficacy and safety of FTR in the treatment of colorectal lesions ≤ 30 mm by comparing prospectively followed FTR cohort to retrospective ESD cohort in the setting of single tertiary endoscopy center. Primary outcomes were technical success rate, R0 resection and curative resection rate, and complication rate. A total of 52 patients in FTR and 50 patients in ESD group were treated between 2015 and 2018. Technical success rate was significantly higher in FTR group (92 vs. 74%, P = 0.01) as well as R0 resection rate (85 vs. 62%, P = 0.01) and curative resection rate (75 vs. 56%, P = 0.01). Complications occurred more frequently in ESD group (40 vs. 13%, P = 0.002), mainly due to high incidence of electrocoagulation syndrome (24 vs. 0%). Total procedure time was substantially shorter in FTR group (26.4 ± 11.0 min vs. estimated 90–240 min). Local residual neoplastic lesions were detected numerically more often in FTR group (12 vs. 5%, P = 0.12). No patient died during follow-up. Compared to ESD, FTR proved significantly higher technical success rate, higher R0 and curative resection rate, and shorter procedure time. In the FTR group, there were significantly less complications but higher incidence of local residual neoplasia. Further research including randomized trials is needed to compare both resection techniques.


2018 ◽  
Vol 06 (09) ◽  
pp. E1112-E1119 ◽  
Author(s):  
Maxime E.S. Bronzwaer ◽  
Barbara A.J. Bastiaansen ◽  
Lianne Koens ◽  
Evelien Dekker ◽  
Paul Fockens

Abstract Background and study aims Colorectal polyps involving the appendiceal orifice (AO) are difficult to resect with conventional polypectomy techniques and therefore often require surgical intervention. These appendiceal polyps could potentially be removed with endoscopic full-thickness resection (eFTR) performed with a full-thickness resection device (FTRD). The aim of this prospective observational case study was to evaluate feasibility, technical success and safety of eFTR procedures involving the AO. Patients and methods This study was performed between November 2016 and December 2017 in a tertiary referral center by two experienced endoscopists. All patients referred for eFTR with a polyp involving the AO that could not be resected by EMR due to more than 50 % circumferential involvement of the AO or deep extension into the AO were included. The only exclusion criterion was lesion diameter > 20 mm. Results Seven patients underwent eFTR for a polyp involving the AO. All target lesions could be reached with the FTRD and retracted into the device. Technical success with an endoscopic radical en-bloc and full-thickness resection was achieved in all cases. Histopathological R0 resection was achieved in 85.7 % of patients (6/7). One patient who previously underwent an appendectomy developed a small abscess adjacent to the resection site, which was treated conservatively. Another patient developed secondary appendicitis followed by a laparoscopic appendectomy. Conclusion This small exploratory study suggests that eFTR of appendiceal polyps is feasible and can offer a minimally invasive approach for radical resection of these lesions. However, more safety and long-term follow-up data are needed to evaluate this evolving technique.


2018 ◽  
Vol 06 (10) ◽  
pp. E1227-E1234 ◽  
Author(s):  
Krijn Haasnoot ◽  
Bas van der Spek ◽  
Christof Meischl ◽  
Dimitri Heine

Abstract 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.


2019 ◽  
Vol 07 (04) ◽  
pp. E471-E476 ◽  
Author(s):  
Osamu Goto ◽  
Motoki Sasaki ◽  
Teppei Akimoto ◽  
Atsushi Tatsuguchi ◽  
Mitsuru Kaise ◽  
...  

Abstract Background and study aims Endoscopic full-thickness resection (EFTR) involves several technical issues that need to be addressed. We devised a novel technique termed third-space EFTR and investigated its feasibility and safety in animal models. Methods Third-space EFTR was performed in three isolated porcine stomachs (ex vivo) and four live pigs (in vivo, 1-week survival). The technique involved a circumferential mucosal incision, submucosal tunnelling on the proximal side, endoscopic suturing of the surrounding mucosa, a circumferential seromuscular incision in the submucosal tunnel, transoral retrieval and entry site closure of the tunnel. The technical outcomes were investigated. Results In the ex vivo study, the procedure was successfully completed with R0 resection. In the in vivo study, the procedure was completed in all pigs; however, R0 resection failed in one pig owing to snaring resection. All pigs survived without severe adverse events. Conclusions Our findings indicate that third-space EFTR is feasible and safe. This technique may be useful as a minimally invasive endoscopic option for reliable treatment of small gastric submucosal tumours.


2018 ◽  
Vol 06 (01) ◽  
pp. E98-E103 ◽  
Author(s):  
Francesco Vitali ◽  
Andreas Naegel ◽  
Juergen Siebler ◽  
Markus Neurath ◽  
Timo Rath

Abstract Background and study aims The full-thickness resection device (FTRD) represents a novel endoscopic treatment method for lesions unresectable with conventional endoscopic techniques. The overall aim of this study was to evaluate technical success and in toto resection rates, recurrence rates, as well as immediate or late complications in patients who underwent polyp removal with the FTRD. Patients and methods Data from a prospectively collected database of 12 patients who underwent 13 over-the-scope clip-based full-thickness resections between June 2015 and June 2017 were analyzed. Follow-up endoscopy was performed in 11 out of 12 patients. Results 13 full-thickness resections were performed in 7 males and 5 females (mean age 64.3 ± 6.3 years). Mean size of the lesions removed with FTRD was 17 ± 4 mm. Location was rectum (n = 6), cecum (n = 2), ascending colon (n = 2), left flexure (n = 1) and right flexure (n = 2). Mean procedure time was 68 ± 35 minutes and mean hospital stay was 2.5 ± 1.2 days. 2 patients developed post-polypectomy syndrome, which resolved after conservative treatment. No perforations and no immediate surgical revision were needed. Histology of the 13 lesions removed with FTRD showed 5 adenomas with low grade intraepithelial neoplasia (IEN), 4 high grade IEN, 1 fibrosis, 1 fibrosis without dysplasia and 2 adenocarcinomas. Technical success was achieved in all procedures (13/13, 100 %). R0 resection was achieved in 10/12 patients (83.3 %). 2 patients underwent surgery because of recurrence or not evaluable margins. In 1 patient no residual malignancy was proven in histological examination, in the other patient residual low grade IEN adenoma. Conclusion FTRD is a minimally invasive approach with good success rate of complete resection and minimal side effects.


Author(s):  
Markus Brand ◽  
Stanislaus Reimer ◽  
Joachim Reibetanz ◽  
Sven Flemming ◽  
Marko Kornmann ◽  
...  

Abstract Purpose Local treatment of small well-differentiated rectal neuroendocrine tumors (NETs) is recommended by current guidelines. However, although several endoscopic methods have been established, the highest R0 rate is achieved by transanal endoscopic microsurgery (TEM). Since a recently published study about endoscopic full thickness resection (eFTR) showed a R0 resection rate of 100%, the aim of this study was to evaluate both methods (eFTR vs. TEM). Methods We retrospectively analyzed all patients with rectal NET treated either by TEM (1999–2018) or eFTR (2016–2019) in two tertiary centers (University Hospital Wuerzburg and Ulm). We analyzed clinical, procedural, and histopathological outcomes in both groups. Results Twenty-eight patients with rectal NET received local treatment (TEM: 13; eFTR: 15). Most tumors were at stage T1a and grade G1 or G2 (in the TEM group two G3 NETs were staged T2 after neoadjuvant chemotherapy). In both groups, similar outcomes for en bloc resection rate, R0 resection rate, tumor size, or specimen size were found. No procedural adverse events were noted. Mean procedure time in the TEM group was 48.9 min and 19.2 min in the eFTR group. Conclusion eFTR is a convincing method for local treatment of small rectal NETs combining high safety and efficacy with short interventional time.


Endoscopy ◽  
2017 ◽  
Vol 49 (11) ◽  
pp. 1092-1097 ◽  
Author(s):  
Yara Backes ◽  
Wouter Kappelle ◽  
Luuk Berk ◽  
Arjun Koch ◽  
John Groen ◽  
...  

Abstract Background and study aims We aimed to evaluate the feasibility and safety of a new, flat-based over-the-scope clip (Padlock Clip) for colorectal endoscopic full-thickness resection (eFTR). Patients and methods We prospectively included 26 patients with lesions < 20 mm. Indications for eFTR were re-resection of the scar of a low risk malignant polyp (n = 11), recurrent adenoma in a non-lifting scar (n = 10), non-lifting polyp (n = 4), and an adenoma located in a diverticulum (n = 1). Results Technical success rate and full-thickness resection rate were 100 % (26/26) and 92 % (24/26), respectively. Median procedure time was 43 minutes (IQR 27 – 56). No complications occurred during the procedure; 3 complications (12 %) occurred within 48 hours, of which one was a perforation requiring laparoscopic suturing. Specimen volumes from eFTR of scar tissue where the original polyp had been ≥ 20 mm (n = 13) were smaller compared with those from non-scar resections or scars where the original polyps had been < 20 mm (n = 13) (median 0.8 vs. 1.5 cm3, P = 0.03). Conclusions In this first series of colorectal eFTR using the Padlock Clip, feasibility was demonstrated. It was relatively safe in view of surgery as the alternative treatment, but could still benefit from technical refinement. Future studies should explore for which indication this technique is most suitable.Trial registration: NTR5562 (Dutch Trial Register).


2019 ◽  
Vol 07 (11) ◽  
pp. E1310-E1315 ◽  
Author(s):  
Vincent Huberty ◽  
Loulia Leclercq ◽  
Martin Hiernaux ◽  
Laurine Verset ◽  
Charlotte Sandersen ◽  
...  

Abstract Background and study aims Endoscopic full-thickness resection (EFTR) is used to achieve R0 resection in difficult situations and as a way to overcome the limitations of endoscopic submucosal dissection. Multiple techniques have been described but adequate tools are still under evaluation. In this study, we evaluated the safety and feasibility of non-exposed endoscopic full-thickness resection using a novel endoscopic suturing device. Materials and methods Full-thickness resections of gastric predetermined lesions were performed on five pigs using the Endomina platform. After creating virtual lesion > 20 mm, sutures were placed around it using this triangulation platform. After tightening the knots, the bulging lesion, internalized into the gastric lumen, was cut with a needle knife. Results R0 resections of large lesions (42 to 60 mm) were achieved in all cases. One perforation occurred and prompted us to improve the procedure by shortening the sutures for more maneuverability and reinforcing the suture line before section. Procedure duration dropped by 50 % between the first case and the fourth case. Histological analysis confirmed successful full-thickness resection of all resected specimens. Conclusion EFTR using this triangulation platform seems feasible for lesions > 20 mm. Additional possible improvements were identified to simplify the procedure before moving to human trials.


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