Creating the Future of (Endoluminal) GI Interventions.

Major innovation into how we pursue diagnosis and therapies for gastrointestinal (GI) diseases is urgently needed to seek better, less invasive, and less costly innovations in diagnostic and therapeutic interventions in the GI tract. Learning from prior paradigm shifts in cardiac and vascular we present here several initial steps we have undertaken to follow the endoluminal path, using advanced imaging methods, including endoscopy, and data management with avoidance of entry into a body cavity when possible. We will review the benefit and ease of incorporating routine fluoroscopy with endoscopy to improve safety and efficiency. We describe the development of "hybrid" procedure rooms for GI interventions and rationale for their use. We also emphasize the importance of collaborating with interventional radiologists, software engineers, and data specialists. We predict major improvement in outcomes in both diagnosis and treatment will follow.

Mixed reality in interventional radiology: a focus on first clinical use of XR90 augmented reality-based visualization and navigation platform.

INTRODUCTION: Augmented reality (AR) and virtual reality (VR) are emerging tools in interventional radiology (IR), enhancing IR education, preprocedural planning, and intraprocedural guidance. AREAS COVERED: This review identifies current applications of AR/VR in IR, with a focus on studies that assess the clinical impact of AR/VR. We outline the relevant technology and assess current limitations and future directions in this space. We found that the use of AR in IR lags other surgical fields, and the majority of the data exists in case series or small-scale studies. Educational use of AR/VR improves learning anatomy, procedure steps, and procedural learning curves. Preprocedural use of AR/VR decreases procedure times, especially in complex procedures. Intraprocedural AR for live tracking is accurate within 5 mm live patients and has up to 0.75 mm in phantoms, offering decreased procedure time and radiation exposure. Challenges include cost, ergonomics, rapid segmentation, and organ motion. EXPERT OPINION: The use of AR/VR in interventional radiology may lead to safer and more efficient procedures. However, more data from larger studies is needed to better understand where AR/VR is confers the most benefit in interventional radiology clinical practice.

Contemporary Assessment of Adhesiolysis and Resection for Adhesive Small Bowel Obstruction in the State of New York.

BACKGROUND: Adhesive small bowel obstruction (aSBO) is a common surgical problem, with some advocating for a more aggressive operative approach to avoid recurrence. Contemporary outcomes in a real-world setting were examined. STUDY DESIGN: A retrospective cohort study was performed using the New York Statewide Planning and Research Cooperative database to identify adults admitted with aSBO, 2016-2020. Patients were stratified by the presence of inflammatory bowel disease (IBD) and cancer history. Diagnoses usually requiring resection were excluded. Patients were categorized into four groups: non-operative, adhesiolysis, resection, and 'other' procedures. In-hospital mortality, major complications, and odds of undergoing resection were compared. RESULTS: 58,976 patients were included. 50,000 (84.8%) underwent non-operative management. Adhesiolysis was the most common procedure performed (n = 4,990, 8.46%), followed by resection (n = 3,078, 5.22%). In-hospital mortality in the lysis and resection groups was 2.2% and 5.9% respectively. Non-IBD patients undergoing operation on the day of admission required intestinal resection 29.9% of the time. Adjusted odds of resection were highest for those with a prior aSBO episode (OR 1.29 95%CI 1.11-1.49), delay to operation ≥3 days (OR1.78 95%CI 1.58-1.99), and non-New York City (NYC) residents being treated at NYC hospitals (OR1.57 95%CI 1.19-2.07). CONCLUSION: Adhesiolysis is currently the most common surgery for aSBO, however nearly one-third of patients will undergo a more extensive procedure, with an increased risk of mortality. Innovative therapies are needed to reduce the risk of resection.

Iterative evaluation of novel access techniques for small bowel obstruction: combining image guided, percutaneous, and endoscopic methods.

Objective: To avoid the need for extensive adhesiolysis in patients with small bowel obstruction (SBO). We evaluated the feasibility of using advanced imaging, percutaneous access, and endoscopy as alternative therapies for SBO. Design: Retrospective case series (IDEAL [Idea, Development, Exploration, Assessment, and Long-term Study Collaborative] stages 1 and 2a). Setting: Single tertiary referral center. Participants: Twelve adults with chronic SBO resulting from inflammatory bowel disease, disseminated cancer, radiation, and/or adhesive disease. Participants were included if they underwent one of three novel access procedures. There were no exclusion criteria. The median age of participants was 67.5 years (range 42-81); two-thirds were women; and median American Society of Anesthesiology class was 3. Interventions: All participants underwent one of three novel access methods, followed by wire-guided balloon dilation of a narrowed area of small bowel. These methods combined endoscopic, fluoroscopic, and surgical techniques. The techniques were (1) a purely endoscopic approach aided by an over-the-scope double-balloon device, (2) a combined endoscopic and percutaneous approach, and (3) a cut-down approach. Main outcome measures: Procedural success (defined as successful access to the small bowel and successful balloon dilation of the stenotic area). Secondary outcomes included major complications, recurrence, length of stay, and procedure time. Results: Procedural success was achieved in 10 of 12 patients (83%). At the time of median follow-up of 10 months, recurrence of SBO was observed in two patients. In only one patient, the novel method did not change the treatment plan. No major complications occurred. Conventional operative intervention was avoided in all patients who achieved technical success with one of the novel approaches. The median postprocedure length of hospital stay was 4 days. Median procedure time was 135 min. Conclusions: Novel minimally invasive approaches to SBO represent feasible alternatives to surgical procedures in select patients. Further study should compare these approaches to standard ones as new methods are refined.

Use of a novel endoscopic overtube with bilateral tool channels for endoscopic resection of experimental lesions and repair of intestinal defects in the right colon: preclinical trial.

BACKGROUND: Endoscopic tumor resection and intestinal defect repair are technically challenging leading to invasive surgery and colectomy performed for resection of benign polyps. In this study, we evaluated the use of an endoscopic overtube with bilateral tool channels for these procedures. METHODS: Using a fresh porcine colorectum in a 3D ex vivo model, 3 cm lesions at the posterior wall of the transverse colon were removed by two different techniques: standard endoscopic submucosal dissection (ESD) technique (STD, n = 12) and ESD using the overtube with an endoscopic snare and grasper through the bilateral channels (OT, n = 12). Procedure times and the number of muscular injuries were evaluated. Using the same model, 5-10 mm full-thickness perforations within a 3 cm mucosal defect at the posterior wall of the transverse colon were closed by two different techniques: standard endoscopic closure technique (STD, n = 12) and endoscopic closure using the overtube with two graspers (OT, n = 12). The outcomes measured included bursting pressure and the number of endoscopic clips used for closure. RESULTS: Endoscopic resection of lesions was performed by the OT group in a significantly shorter total procedure time (STD vs. OT = median 38.9 min vs. 17.3, p < 0.001) and with fewer muscular injuries (median 0 vs. 2, p = 0.002), compared with the STD group. After repair of intestinal defects, the OT group showed higher median bursting pressures (STD vs. OT = 11.2 mmHg vs. 57.1, p = 0.008) despite using fewer clips (median 13 vs. 10, p < 0.001). CONCLUSION: This study demonstrates a novel traction technique with an endoscopic overtube using multiple instruments to remove lesions and repair intestinal defects in the colon more effectively. This endoscopic platform could provide a safe alternative to invasive surgical treatment.

Luminal mapping reveals mesenteric predominance of colonic adenomas and adenocarcinomas.

BACKGROUND: Previous studies have examined the relationship between colorectal tumor distribution and metastasis, but the tumor luminal location and associative risk factors promoting tumor growth remain unknown. METHODS: In this study, we mapped the luminal distribution of human colonic adenomas/adenocarcinomas and their association with various physiologic parameters. RESULTS: We identified a mesenteric predominance for colonic adenomas and adenocarcinomas. CONCLUSION: The findings of this study raise the possibility of novel mechanistic pathways in the development of adenomas and subsequent transformation into adenocarcinomas.

A pilot randomized controlled trial comparing THUNDERBEAT to the Maryland LigaSure energy device in laparoscopic left colon surgery.

BACKGROUND: The THUNDERBEAT is a multi-functional energy device which delivers both ultrasonic and bipolar energy, but there are no randomized trials which can provide more rigorous evaluation of the clinical performance of THUNDERBEAT compared to other energy-based devices in colorectal surgery. The aim of this study was to compare the clinical performance of THUNDERBEAT energy device to Maryland LigaSure in patients undergoing left laparoscopic colectomy. METHODS: Prospective randomized trial with two groups: Group 1 THUNDERBEAT and Group 2 LigaSure in a single university hospital. 60 Subjects, male and female, of age 18 years and above undergoing left colectomy for cancer or diverticulitis were included. The primary outcome was dissection time to specimen removal (DTSR) measured in minutes from the start of colon mobilization to specimen removal from the abdominal cavity. Versatility (composite of five variables) was measured by a score system from 1 to 5 (1 being worst and 5 the best), and adjusted/weighted by coefficient of importance with distribution of the importance as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue manipulation 0.1. Other variables were: dryness of surgical field, intraoperative and postoperative complications, and mortality. Follow-up time was 30 days. RESULTS: 60 Patients completed surgery, 31 in Group 1 and 29 in Group 2. There was no difference in the DTSR between the groups, 91 min vs. 77 min (p = 0.214). THUNDERBEAT showed significantly higher score in dissecting and tissue manipulation in segment 3 (omental dissection), and in overall versatility score (p = 0.007) as well as versatility score in Segment 2 (retroperitoneal dissection p = 0.040) and Segment 3 (p = 0.040). No other differences were noted between the groups. CONCLUSIONS: Both energy devices can be employed effectively and safely in dividing soft tissue and sealing mesenteric blood vessels during laparoscopic left colon surgery, with THUNDERBEAT demonstrating some advantages over LigaSure during omental dissection and tissue manipulation. CLINICALTRIAL: gov # NCT02628093.

Use of an endoscopic flexible grasper as a traction tool for excision of polyps: preclinical trial.

Endoscopic submucosal dissection (ESD) is challenging in the right colon. Traction devices can make it technically easier. In this study, we evaluated a flexible grasper with articulating tip and elbow-like bending (IgE) through a double-balloon surgical platform (DESP), compared with an earlier generation grasper without elbow-like bending (Ig). The reach of Ig/IgE was investigated at eight locations using a synthetic colon within a 3D model. Using a fresh porcine colorectum, 4 cm pseudo-polyps were created at the posterior wall of the ascending colon. Fifty-four ESD procedures were performed using three techniques: standard ESD (STD), ESD using Ig (DESP + Ig), and ESD using IgE (DESP + IgE). IgE was able to reach the full circumference at all the locations, whereas the medial walls proximal to the descending colon were out of Ig's reach. Compared with the STD, both DESP + Ig and DESP + IgE showed significantly shorter procedure time (STD vs. DESP + Ig vs. DESP + IgE = median 48.9 min vs. 38.6 vs. 29.9) and fewer injuries (1.5 vs. 0 vs. 0). Moreover, the DESP + IgE had a shorter procedure time than the DESP + Ig (p = 0.0025). The IgE with DESP increased instrument reach compared to Ig, and likely represented a traction tool for excision of large pseudo-polyps in the right colon.

Intraluminal gas escape from biopsy valves and endoscopic devices during endoscopy: caution advised during the COVID-19 era.

Background and study aims The risk of aerosolization of body fluids during endoscopic procedures should be evaluated during the COVID-19 era, as this may contribute to serious disease transmission. Here, we aimed to investigate if use of endoscopic tools during flexible endoscopy may permit gas leakage from the scope or tools. Material and methods Using a fresh 35-cm porcine rectal segment, a colonoscope tip, and manometer were placed intraluminally at opposite ends of the segment. The colonoscope handle, including the biopsy valve, was submerged in a water bath. Sequentially, various endoscopic devices (forceps, clips, snares, endoscopic submucosal dissection (ESD) knives) were inserted into the biopsy valve, simultaneously submerging the device handle in a water bath. The bowel was slowly inflated up to 74.7 mmHg (40 inH 2 O) and presence of gas leakage, leak pressure, and gas leakage volume were measured. Results Gas leakage was observed from the biopsy valve upon insertion and removal of all endoscopic device tips with jaws, even at 0 mmHg (60/60 trials). The insertion angle of the tool affected extent of gas leakage. In addition, gas leakage was observed from the device handles (8 of 10 devices) with continuous gas leakage at low pressures, especially two snares at 0 mmHg, and an injectable ESD knife at 0.7 ±â€Š0.8 mmHg). Conclusions Gas leakage from the biopsy valve and device handles commonly occur during endoscopic procedures. We recommend protective measures be considered during use of any tools during endoscopy.

Endoscopic submucosal dissection of large polyps in the right colon using an endoscopic snare with a double-balloon endolumenal interventional platform: an ex vivo study in a porcine colorectal model.

BACKGROUND: Endoscopic submucosal dissection (ESD) is a challenging procedure for the removal of colorectal tumors, especially tumors located in the right colon. The use of traction could make this procedure technically easier and reduce procedure times and complication rates. In this study, we demonstrated the feasibility and utility of a traction technique utilizing an endoscopic snare through an overtube, a double-balloon endolumenal interventional platform (DEIP) in a porcine colorectal model. METHODS: A total of 120 procedures were performed using three different techniques: standard ESD technique (STD), ESD with DEIP (DEIP alone), and ESD with DEIP and a snare (DEIP + Snare). The snare was passed inside the overtube and used as a grasper on the tissue to provide traction. Lesions 3 or 4 cm in diameter were removed with a 5 mm margin from the anterior and posterior walls of the proximal Transverse Colon, the Hepatic Flexure, and the posterior wall of the Cecum. The outcomes measured included procedure times and the number of muscularis propria injuries. RESULTS: The DEIP + Snare group showed significantly shorter total procedure and submucosal dissection times for lesions in all locations (median 28.1 min (DEIP + Snare, n = 32) vs 39.8 (STD, n = 32) vs 39.7 (DEIP alone, n = 32); 7.5 min vs 25.3 vs 25.1) and had fewer muscularis propria injuries (median 0 [range 0-2] vs 2 [0-7] vs 1 [0-6]) than the two other groups. Larger lesions (4 cm) were successfully removed by regrasping the tissue in DEIP + Snare group, which showed significantly shorter total procedure time [31.4 min (DEIP + Snare, n = 8) vs 40.1 (STD, n = 8) vs 45.6 (DEIP alone, n = 8)] and submucosal dissection time (12.3 min vs 27.6 vs 29.1) than the two other groups. CONCLUSIONS: ESD traction technique with an endolumenal platform and snare enables faster removal of large polyps in the right colon with fewer injuries than standard methods of ESD.

Rectal Prolapse Repair with Abdominal Fixation Under Sedation and Local or Epidural Anesthesia: Prospective Pilot Study in 10 Elderly Subjects.

Background: Rectal prolapse (RP) is primarily a disease of the elderly, where treatment may be associated with significant postoperative morbidity including that related to anesthesia. Objective: The aim of this study was to evaluate the safety and feasibility of a novel abdominal approach to RP repair under sedation and local anesthesia and to assess short- and long-term clinical outcomes in elderly patients (>70 years). Design Settings: This is a prospective pilot study with 10 patients using a novel RP repair. The anesthesia type was local or epidural with sedation. Follow-up was done at 30 days, 12, and 24 months. Patients: Patients were men and women >70 years of age with RP. Main Outcome Measures: (1) Feasibility: successful completion of RP repair using the novel abdominal approach with laparoscopic assistance. (2) Safety: safety was measured by the incidence of the intraoperative complications (bowel perforation, organ injury, and bleeding requiring blood transfusion). (3) Sedation and local anesthesia feasibility: surgery was safely completed without patient intubation. Results: Ten female patients >70 years of age underwent RP repair using the novel abdominal approach. General anesthesia was not required in any of the 10 patients. Two patients recurred within 6 months. One of the patients with recurrence of RP subsequently underwent laparoscopic rectopexy, and the other was minimal and required no further treatment. One mortality occurred at 3 months unrelated to the procedure. No other anesthetic or surgical intraoperative and postoperative complications were observed. Limitations: This is a single-institution pilot study. Conclusions: Abdominal RP repair under sedation and regional anesthesia appears feasible and safe in elderly patients and may, in the future, provide an effective alternative to current treatment options for RP, avoiding general anesthesia. ClinicalTrial.gov registration number: NCT01980043.

Correction to: Facilitating endoscopic submucosal dissection: double balloon endolumenal platform significantly improves dissection time compared with conventional technique (with video).

Gerd Silberhumer's name was misspelled in the original publication; it is correct as displayed here.

Facilitating endoscopic submucosal dissection: double balloon endolumenal platform significantly improves dissection time compared with conventional technique (with video).

BACKGROUND: Flexible endoscopes ability to manipulate the intestinal environment is limited. As a result, complex endolumenal procedures are often technically demanding and result in long procedure times, impacting institutional resources. Single- and double-balloon add-on endoscopic devices have been employed throughout the GI tract to facilitate tissue control e.g., small bowel enteroscopy, with recent reports suggesting a possible colonic utility for complex procedures e.g., ESD. Our objective was to objectively analyze the efficacy of a new double-balloon device in performing ESD. METHODS: Ex vivo-12 simulated colonic lesions were created in porcine rectum using a standard 40 mm diameter template. Two categories were evaluated, standard cap technique ESD and double-balloon assisted ESD with retraction (ESD-R). Cases were performed sequentially. In vivo-Six, 40 mm lesion ESD-R's were performed in a porcine model. The primary outcomes of this study were total procedure and dissection times. RESULTS: In ex vivo studies, the median total procedure time with the double-balloon platform was significantly shorter than the traditional ESD technique (29 ± 18 vs. 57 ± 21 min, p = 0.03). In the in vivo studies, lesions were successfully removed in a mean time of 48 min, with a dissection time of 20 min with no significant complications. Balloon-clip retraction and specimen retrieval capabilities were used in all double-balloon assisted cases. After 6 cases, times were significantly shorter (ex vivo 47 vs. 17 min; in vivo 57 vs. 27 min). CONCLUSIONS: We have demonstrated the development of a unique technical ESD method facilitated by a new double-balloon device. Ex and in vivo investigation demonstrated superiority of ESD-R over the conventional ex vivo method. The DB device provided increased stability, improved visualization and tissue traction, which significantly reduced dissection time. Such an approach may increase safety, improve patient outcomes, and may prevent unnecessary surgeries for benign conditions.

Treatment Effects Can Mimic Recurrent Extramammary Paget Disease in Perianal Skin.

The histologic differential diagnosis of perianal Paget disease includes malignant melanoma, pagetoid spread of squamous cell carcinoma, and secondary involvement by colorectal carcinoma. While consideration of these entities is useful when establishing a diagnosis, it does not apply when patients with Paget disease undergo surveillance for recurrent disease. Treatment of perianal Paget disease consists of a combination of surgical excision with skin grafts and topical chemotherapeutic agents that induce cytologic alterations in benign cells and simulate recurrent malignancy. To evaluate the therapy-related changes and possible diagnostic pitfalls in patients with Paget disease, we reviewed 412 posttreatment tissue samples from 3 women with primary perianal Paget disease who underwent wide excision, skin grafting, and topical 5-fluorouracil therapy. Biopsy samples from engrafted skin often displayed single and clustered cells with hyperchromatic nuclei dispersed in the deep epidermis. Similar cells were scattered throughout all levels of the epidermis in biopsy samples following topical chemotherapy. The abnormal cells were negative for cytokeratin 7 (CK7) and mucicarmine in both situations. Disease ultimately recurred in all patients; some Paget cells showed classic features with eosinophilic or mucinous cytoplasm and eccentric nuclei, whereas others were smaller with less conspicuous atypia. All Paget cells showed strong, membranous CK7 staining. In short, treatment of perianal Paget disease can elicit cytologic abnormalities in benign epithelial cells that simulate the cytologic features of recurrent disease, and can diminish the atypia of Paget cells. Immunohistochemical stains for CK7 can be helpful when evaluating surveillance samples from these patients.

Antigravity ESD - double-balloon-assisted underwater with traction hybrid technique.

BACKGROUND AND STUDY AIMS: Complex colorectal polyps or those positioned in difficult anatomic locations are an endoscopic therapeutic challenge. Underwater endoscopic submucosal dissection (UESD) is a potential technical solution to facilitate efficient polyp removal. In addition, endoscopic tissue retraction has been confined to limited methods of varying efficacy and complexity. The aim of this study was to evaluate the efficiency of a unique UESD technique for removing complex polyps using double-balloon-assisted retraction (R). MATERIALS AND METHODS: Using fresh ex-vivo porcine rectum, 4-cm polyps were created using electrosurgery and positioned at "6 o'clock" within an established ESD model. Six resections were performed in each group. Underwater techniques were facilitated using a novel double-balloon platform (Dilumen, Lumendi, Westport, Connecticut, United States). RESULTS: UESD-R had a significantly shorter total procedural time than cap-assisted ESD and UESD alone (24 vs. 58 vs. 56 mins). UESD-R produced a dissection time on average of 5 minutes, attributed to the retraction provided. There was also a subjective significant reduction in electrosurgical smoke with the underwater techniques contributing to improved visualization. CONCLUSIONS: Here we report the first ex-vivo experience of a unique double-balloon endoscopic platform optimized for UESD with tissue traction capability. UESD-R removed complex lesions in significantly shorter time than conventional means. The combined benefits of UESD and retraction appeared to be additive when tackling complex polyps and should be studied further.