Introduction

ESD (endoscopic submucosal dissection) and EFTR (endoscopic full-thickness resection) are treatments of choice in the endoscopic resection of small and superficially submucosal invasive GI lesions. It is often challenging to assess the best curative option in this setting. ESD is currently thought to be the gold standard technique.

Aims & Methods

We retrospectively analyzed all gastrointestinal pT1 lesions < 30 mm resected by either ESD or EFTR in our Unit from 2016 and December 2022. As primary endpoints we assessed en bloc resection, R0 resection (clear margins) and curative resection (no further need for surgery) rate. As secondary endpoints we analyzed mean procedural time, cost and adverse events that occurred within or after both procedures. Statistical analysis was performed with Pearson chi-square test.

Results

35 ESD and 32 EFTR were enrolled. En bloc resection was achieved in, respectively, 90 % (32/35) and 96% (30/32), with no statistical difference (RR 0.93, p= 0.9), likewise R0 resection (29/35, 83% vs 30/32, 96%, RR 0.86, p=0.7) and curative resection (23/35, 66% vs 20/32, 64%, RR 1.03, p= 0.7). Mean procedural time was lower in EFTR, although not significantly (67 ± 37 min vs 50 ± 15.6 min, p=0.7), while adverse events rate was similar (5/35, 13% vs 3/32, 10%). Eventually, mean procedural cost per hospitalization day was lower in ESD than EFTR (1503 ± 360 € vs 2260 ± 210€), considering a medium hospitalization time of 2.4 days and 2 days, respectively.

Conclusion

ESD and EFTR turned out to be equally successful in achieving R0 and curative resection in pT1 small lesions, so that ESD should remain gold standard in an experienced setting, even though EFTR could allow easier and faster en bloc resection in most challenging ESD, albeit more expensive.

Introduction

Endoscopic full thickness resection (EFTR) is emerging as an effective modality for mucosal and submucosal lesions in colorectum.

Aims & Methods

In this systematic review and meta-analysis, we aimed to analyze the success and safety of device assisted EFTR in colon and rectum. A literature search was performed in Embase, PubMed, Medline databases for studies evaluating device assisted EFTR between inception to October-2022. The primary outcome of the study was clinical success (R0 resection) with EFTR. Secondary outcomes included technical success and adverse events.

Results

29 studies with 3467 patients [2045(59%) males] with 3492 lesions were included in the analysis. The lesions were located in right colon in 1660 (47.5%), left colon in 990 (28.6%) and rectum 840 (24.3%). EFTR was performed for sub-epithelial lesions in 252 (7.2%) patients. Pooled mean size of the lesions was 16.6 mm (95% CI 14.9 – 18.2, I ² 98%). Technical success was achieved in 87.1% (95% CI 85.1%-88.9%, I²39%) procedures. The pooled rate of en bloc resection was 87.9% (95% CI 85.1%-88.9%, I²50%) and R0 resection was 81.6% (95% CI 78.8% to 84.2%, I²57%). In sub-epithelial lesions, pooled rate of R0 resection was 94.3% (95% CI 89.7% to 96.9%, I² 0%). Pooled rate of adverse events was 12.1%(95% CI 10.3%-14.1%, I²44%) and major adverse events requiring surgery was 2.5% (95% CI 2.0%-3.1%, I²0%).

Conclusion

Device assisted EFTR is a safe and effective treatment modality in cases with adenomatous and sub-epithelial colorectal lesions. Comparative studies are required with conventional resection techniques including endoscopic mucosal resection and submucosal dissection.

Introduction

Rigid surgical instruments used for conventional laparoscopic surgery provide limited movement, and it is difficult to perform skillful surgery due to their long, jointless straight features. Articulated instruments could have the same advantages seen in robotic surgery, such as excellent control in smaller spaces, restoration of more intuitive and ergonomic movements, and the ability to overcome obstacles on a direct visual line. The aim of this study was to evaluate the surgical performance and clinical outcomes of patients following laparoscopic colorectal surgery with multijoint laparoscopic instruments, ArtiSential® (LivsMed, Seongnam, Korea), compared with those using conventional instruments.

Aims & Methods

Patients aged 19–80 years undergoing elective laparoscopic surgery for colorectal disease between December 2021 and November 2022, were consecutively enrolled. The first 20 cases underwent conventional laparoscopic surgery, and the latter 50 cases underwent laparoscopic surgery using ArtiSential®. Unedited operative videos were submitted to the Crowd-Sourced Assessment of Technical Skills (C-SATS) platform for evaluation using the Global Operative Assessment of Laparoscopic Skills (GOALS), which is a validated tool for technical proficiency. Each of GOALS’ four domains (bimanual dexterity, depth perception, efficiency, and tissue handling) was scored on a Likert scale between 1 and 5, scoring anchor, with a total score ranging from 4 to 20. The learning curve analysis was performed using the cumulative sum control chart (CUSUM) for GOALS grades (Registration number: KCT0006798).

Results

There was no significant difference between group with regards to type of operation, hospital stay, and 30-day postoperative complication. The GOALS’ grades were similar between the two groups (15.7 ± 0.7 vs. 15.9 ± 0.5, P = 0.190), but the scores in two domains (depth perception and tissue handling) were significantly higher in the ArtiSential® group (3.9 ± 0.3 vs. 4.0 ± 0.2, P = 0.014 and 3.9 ± 0.2 vs. 4.1 ± 0.2, P = 0.048, respectively) compared with those in the conventional group. In addition, patients in the ArtiSential® group experienced a shorter operation time (122.3 ± 58.9 vs. 88.1 ± 35.1, P = 0.022) and less intraoperative blood loss (56.5 ± 69.9 vs. 29.8 ± 1.4, P = 0.002) than those in the conventional group. According to the CUSUM learning curve analysis, the first 10 cases using ArtiSential® were in the inexperienced phase, and the remaining 40 cases were in the experienced phase. The GOALS’ score in the experienced phase of ArtiSential® was improved compared with that in the conventional group (16.0 ± 0.5 vs. 15.7 ± 0.7, P = 0.037).

Conclusion

A plateau in the learning curve of laparoscopic colorectal surgery performed with an articulated instrument was observed in approximately 10 cases, and it can be expected that surgical proficiency in the experienced phase increases without deterioration of clinical outcome as compared to that in conventional surgery.

References

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Disclosure

This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grantnumber: HI20C2092).

Introduction

Endoscopic full thickness resection (EFTR) of the colon has been described as an effective practicable method for resection of recurrent /advanced neoplastic lesions, but its performance and success may be difficult or different according to location of the lesion in the corresponding colonic segment.
The aim was to investigate the segment-specific efficacy and safety of EFTR in the colon using a full thickness resection device (FTRD) from real-world data.

Aims & Methods

EFTR was conducted in patients being referred to either of the 4 participating centers after previous colonoscopy leading to a diagnosis suitable for EFTR. The primary efficacy measure of EFTR was histologically complete resection (R0) of the lesion. Safety was investigated considering the frequency of adverse events (AE) to EFTR occurring during the procedure or afterwards.

Results

105 patients (66m/39f; median 70yrs) were included in the analysis. FTRD was technically successful in 101 patients (96.2%) with a median lesion size of 20 x 19mm (15-24).
Histologically R0 resection was obtained in 77.1% of the patients with a segment-specific range from 90% (rectum), 70.6% sigmoid, 78.6% descending colon to 62.5% (transverse colon), while in ascending colon and cecum resection rates of 76.9 and 83.3% could be achieved.
Overall, adverse event rate (AE, any) were documented in 33 patients (31.4%), with only 1 perforation in sigmoid (0.95%), while the others were minor, abdominal postsurgical pain (18.1%), hematochezia (9.5%), and haemoglobin decline (7.6%). Topographical analysis revealed that AE were most attributable to transverse colon (12.5%), while in the other segments AE were each lower or equal than 8.2%; the lowest rate of AE was found in rectum with 1.4%.

Conclusion

EFTR is efficacious for the endoscopic treatment of colorectal lesions with best outcome parameters in rectum (high R0 rate, low AE), followed by cecum. The other segments appeared to be more difficult for complete resection and showed a higher AE rate. Transverse colon was identified with lowest R0 resection rates and highest frequency of AE. While only one major complication occurred, minor complications in all other segments were below 8.2% and short-lived.

Introduction

Post surgical fistulas of the upper digestive tract(UDT) are associated with significant morbidity and mortality. The indication for surgery may influence outcomes.

Aims & Methods

We aimed to evaluate the clinical presentation,efficacy and safety of a primarily endoscopic approach to management of post surgical fistula of the UDT comparing oncologic versus non-oncologic indications for surgery.

Multicentre retrospective analysis involving 126 consecutive patients who underwent primarily endoscopic management of post surgical fistulas of the UDT between March2009-January2022. Clinical efficacy (fistula closure) and adverse events in patients with fistulas after oncologic and non-oncologic surgery were compared.Qualitative variables were evaluated with Chi-square test. Quantitative variables with non-normal distribution were expressed as median(min-max) and evaluated with Mann-Whitney´s test. We performed logistic regression analysis to determine factors associated with fistula closure and adverse events. A p value <0.05 was considered statistically significant (IBM SPSS28).

Results

Median age was 57(17-89) years and 73(60%) patients were female. Indications for surgery were non-oncologic in 80 patients(63.5%) ((mostly bariatric, n=73)) and cancer in 46(36.5%) patients.
Patients undergoing oncologic surgery were older and with male predominance. There were no differences regarding median time to detect fistula or fistula size between the groups. Fever, abdominal pain and abdominal collections were more frequent in non-oncologic surgery group. On laboratory analysis, only haemoglobin was significantly lower in patients undergoing oncologic surgery(Table1). We found no significant difference on leukocyte count, neutrophil percentage, C-reactive protein, AST, ALT, total bilirubin, INR or creatinine.

		Oncologic	Non-oncologic	p-value
Characterization	Median age	71(52-89),	45(17-79)	<0.001
	Female gender	21(26%)	35 (76%)	<0.001
	Median time to fistula detection(days)	8(1-83)	6(1-387)	0.08
	Fistula size(mm)	5.0(2.0-25.0)	5.0(1.0-30.0)	0.671
Clinical presentation	Fever	18(39%)	49(61%)	0.049
	Abdominal pain	13(28%)	46(58%)	0.006
	Abdominal collections	11(n=24%)	48(60%)	<0.001
	Sepsis	13(n=28)	21(26%)	0.309

Endoscopic interventions were similar in both groups and included placement of a covered metallic stent in 64(80.0%) non-oncologic patients and 34(73.9%) oncologic patients (p=0.506) and clips in 99(48.8%) oncologic patients and 19(41.3%) (p=0.461) non-oncologic patients. The frequency of early adverse events (<1 week) (8(17%) vs 14(18%), p=1.0),as well as late adverse events (10(22%)vs 21(26%), p=0.670) were similar in both groups
We documented clinical success (fistula closure) in 72(90%) of non-oncologic patients and 34(74%, p=0.023) of oncologic patients, but after a similar median duration of management (13 (1-423) weeks vs 6(1-55) weeks, p=0.11) and number of endoscopies (3(1-8) vs 2(1-13), p=0.706).
After a median follow up of 36(1-147) and 12.5(1-113) months, 6(7.5%) and 28(60.9%) patients died, respectively from the group of non-oncologic and oncologic surgery. In the oncologic surgery group, 12 patients (48%) died from progression of oncologic disease.

Conclusion

A primarily endoscopic approach is effective in >70% of patients with fistulas after UDT surgery but it´s efficacy was significantly lower in patients with fistulas after oncologic surgery compared to non-oncologic surgery and this may have been due to the higher age and male predominance.

Introduction

Stenosis after esophageal Endoscopic Submucosal Dissection (ESD) has a high incidence of ranks, and muscular injury might be an important risk factor for esophageal stenosis.

Aims & Methods

Our study aimed to classify muscular injury degree and investigate its association with postoperative stenosis. This retrospective study included 1,033 patients with esophageal mucosal lesions treated by ESD between August 2015 and March 2021. Demographic and clinical parameters were analyzed, and stenosis risk factors were identified using multivariate logistic regression. A novel muscular injury classification system was proposed and further used to investigate the association between the different degrees of muscular injury and postoperative stenosis. Finally, a scoring system was established for the prediction of muscular injury.

Results

Of 1,033 patients, 118 (11.4%) had esophageal stenosis. The multivariate analysis demonstrated that the history of endoscopic esophageal treatment, circumferential range, and muscular injury were significant risk factors for esophageal stenosis. Patients with Type II muscular injuries tended to develop complex stenosis (n = 13, 36.1%, p < 0.05). Moreover, Type II muscular injuries were more likely to predispose patients to severe stenosis than Type I (73.3 and 92.3%, respectively). According to the scoring system for predicting muscular injury, patients with high scores (3-6) were more likely to suffer muscular injury. The score model presented good discriminatory power in the internal validation (AUC: 0.706; 95% CI: 0.645-0.767) and goodness-of-fit in the Hosmer-Lemeshow test (p = 0.865).

Conclusion

Muscular injury was an independent risk factor for esophageal stenosis. The scoring system demonstrated good performance in predicting muscular injury during ESD.

References

1. Yang D, Othman M, Draganov PV. Endoscopic Mucosal Resection vs Endoscopic Submucosal Dissection For Barrett's Esophagus and Colorectal Neoplasia. Clin Gastroenterol Hepatol. 2019;17:1019-28.
2. Chen M, Dang Y, Ding C, et al. Lesion size and circumferential range identified as independent risk factors for esophageal stricture after endoscopic submucosal dissection. Surg Endosc. 2020;34:4065-71.
3. Ishihara R, Arima M, Iizuka T, et al. Endoscopic submucosal dissection/endoscopic mucosal resection guidelines for esophageal cancer. Dig Endosc. 2020;32:452-93.
4. Zhang BZ, Zhang Y, Wang YD, et al. Stent placement to prevent strictures after esophageal endoscopic submucosal dissection: a systematic review and meta-analysis. Dis Esophagus. 2021;34.
5. Wu QN, Xu XY, Zhang XC, et al. Submucosal fibrosis in achalasia patients is a rare cause of aborted peroral endoscopic myotomy procedures. Endoscopy. 2017;49:736-44.
6. Nagami Y, Ominami M, Shiba M, et al. Prediction of esophageal stricture in patients given locoregional triamcinolone injections immediately after endoscopic submucosal dissection. Dig Endosc. 2018;30:198-205.
7. Xu Y, Lin Z, Zhong S, et al. Muscular injury was identified the risk factor of post-operative stenosis after large area but non-circumferential esophageal endoscopic submucosal dissection. Scand J Gastroenterol. 2022:1-8.

Introduction

In recent years, various novel technologies have emerged to aid health care providers in optimizing patient management. Mixed Reality (MR) is an interactive, real-time processed, three-dimensional (3D) registered spatial computing technology that combines virtual (VR) and augmented reality (AR). Advantageous features of MR in endoscopy are the gesture operation and 3D spatial guidance, allowing more comfortable ergonomic interactions for GI endoscopists (translation and rotation) avoiding the need for touching monitors, increasing situational awareness, with a potential reduction or even replacement of monitors in the endoscopy suite.

Aims & Methods

We aim to evaluate the feasibility of mixed-reality holographic monitors in terms of interconnectivity and user’s experience during endoscopic procedures. A non-blinded, non-randomized, interventional trial to assess the added utility and user’s experience with MR was performed from November 2022 to March 2023 in a single tertiary center. The GI endoscopists used an MR system, a dedicated processor and software, paired with VR lenses during diagnostic procedures in adult patients. The primary outcomes were device technical assessment (interconnectivity and frame rate) and user’s acceptance (comfort, functionality, and learnability), measured by the specialized platform and Likert scale, respectively.

Results

30 operators used the dedicated software as replacement of the surgical monitors. 86.7% of the operators were males and the median age was 36 years (31 – 37). Fifteen esophagogastroduodenoscopies (50.0%), three cholangioscopies (10.0%), ten colonoscopies (33.3%), and two endoscopic ultrasounds (6.7%) were performed. One hologram (Figure 1) was used in 90.0% of the procedures, two procedures used two holograms (6.7%), and one cholangioscopy used three holograms (3.3%). The operators’ acceptance in terms of comfort, functionality, and learnability is summarized in table 1. The mean latency was 89.7 ± 2.87ms and the holograms performed at a 58.50 ± 1.11 frames per second (FPS).

Table 1. Summary of the Likert scales evaluating the users’ acceptance for Mixed-Reality Holographic Screens in terms of comfortability, functionality, learnability, and image quality.

	Very bad	Bad	Acceptable	Good	Very good
Gestures functionality	-	-	3/30 (10.0%)	18/30 (60.0%)	9/30 (30.0%)
Holographic Image Quality	-	3/30 (10.0%)	5/30 (16.7%)	16/30 (53.3%)	6/30 (20.0%)
Surgical field image through the lenses	-	-	4/30 (13.3%)	14/30 (46.7%)	12/30 (40.0%)
	Very bad	Hard	Acceptable	Easy	Very easy
Gestures learnability	-	-	3/30 (10.0%)	20/30 (66.7%)	7/30 (23.3%)
	Totally Disagree	Disagree	Neither agree nor disagree	Agree	Totally agree
Lenses Comfortability				22/30 (73.3%)	8/30 (26.7%)
Posture Comfortability		2/30 (6.7%)		23/30 (76.7%)	5/30 (16.7%)

Conclusion

This dedicated system can replace surgical monitors within endoscopy units with good interconnectivity and FPS rate. Operators indicated that the software and hardware were comfortable and easy to use. Prospective studies assessing more cases with remote assistance and risk of potential complications should be performed for real-world evaluation of this MR system. NCT05640401.

References

1. Zhang J, Zhu L, Yao L, Ding X, Chen D, Wu H, Lu Z, Zhou W, Zhang L, An P, Xu B, Tan W, Hu S, Cheng F, Yu H. Deep learning-based pancreas segmentation and station recognition system in EUS: development and validation of a useful training tool (with video). Gastrointest Endosc. 2020 Oct;92(4):874-885.e3. doi: 10.1016/j.gie.2020.04.071. Epub 2020 May 6. Erratum in: Gastrointest Endosc. 2021;93(3):781. PubMed ID: 32387499
2. Yeung AWK, Tosevska A, Klager E, Eibensteiner F, Laxar D, Stoyanov J, Glisic M, Zeiner S, Kulnik ST, Crutzen R, Kimberger O, Kletecka-Pulker M, Atanasov AG, Willschke H. Virtual and Augmented Reality Applications in Medicine: Analysis of the Scientific Literature. J Med Internet Res. 2021;23(2):e25499. doi: 10.2196/25499. PubMed ID: 33565986
3. Reis G, Yilmaz M, Rambach J, Pagani A, Suarez-Ibarrola R, Miernik A, Lesur P, Minaskan N. Mixed reality applications in urology: Requirements and future potential. Ann Med Surg (Lond). 2021; 66: 102394. doi: 10.1016/j.amsu.2021.102394. eCollection 2021. Review. PubMed ID: 34040777
4. Verhey JT, Haglin JM, Verhey EM, Hartigan DE. Virtual, augmented, and mixed reality applications in orthopedic surgery. Int J Med Robot. 2020 Apr;16(2):e2067. doi: 10.1002/rcs.2067. Epub 2020. Review. PubMed ID: 31867864

Disclosure

Carlos Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Boston Scientific, Steris, Medtronic, Motus, Micro-tech, G-Tech Medical Supply, CREO Medical, EndoSound, and mdconsgroup. The other authors declare no conflicts of interest.