Novel endoscopic duodenal observation protocol based on Seven Pictures Rule for detecting duodenal neoplasms during esophagogastroduodenoscopy: Prospective observational study.

OBJECTIVES: No protocol for esophagogastroduodenoscopic examination of the duodenum has been established. We examined the feasibility and ability to detect neoplasms of a novel duodenal examination protocol. METHODS: This was a two-facility, prospective, observational study. Our protocol, the Seven Pictures Rule (7PR), requires pictures of the following seven locations: anterior and posterior to the bulb, area of and contralateral to the superior duodenal angle, area of and contralateral to the ampulla, and the transverse duodenum. The primary outcome was rate of completion of 7PR. Secondary outcomes were overall rates of detecting neoplasms, rates of detecting neoplasms for each location, examination time, and completion rates for standard or ultrathin endoscopes. RESULTS: There were 1549 participants. The 7PR completion rate was 81.1% and the detection rates of overall neoplasms, adenomas, and carcinomas were 0.84%, 0.71%, and 0.06%, respectively. The area in which most neoplasms was detected was contralateral to the ampulla (69.2%), and the fewest the transverse duodenum (0%). Mean duration of duodenal examination was 53.1 s. Completion rates for standard vs. ultrathin were 84.4% (1077/1276) vs. 65.6% (179/273) (P < 0.01), respectively. CONCLUSIONS: Seven Pictures Rule is acceptable for duodenal examination and a potential quality indicator.

A Novel Fluorescence-Based Leak Test Method for Rectal Anastomoses Using Aerosolized Indocyanine Green.

BACKGROUND: The intraoperative air leak test is commonly performed during rectal surgery to evaluate anastomotic integrity. However, its drawbacks include occasional difficulties in visualizing the exact point of the leak while maintaining the pelvis under saline, the need for repeat testing to identify the leak point, and a lack of continuous visualization of the leak point. OBJECTIVE: To evaluate the feasibility and clinical applicability of using aerosolized indocyanine green, a fluorescent tracer, for detecting rectal anastomotic leakage. DESIGN: Animal preclinical study. SETTING: Animal laboratory at Kagawa University. PATIENTS: Six healthy adult female beagles were included. INTERVENTIONS: An anastomotic leakage model with a single air leak point was created in each dog. Indocyanine green was aerosolized using a nebulizer kit with a stream of carbon dioxide flowing at 1.5 to 2.0 L/min. The aerosol was administered into the rectum transanally, and laparoscopic observations were performed. MAIN OUTCOME MEASURES: Air leak points were observed using a near-infrared fluorescence laparoscope, after which the presence of corresponding indocyanine green fluorescence was verified. RESULTS: Aerosolized indocyanine green was visualized laparoscopically at all anastomosis sites but not elsewhere. The median time from the administration of the aerosol to its visualization was 4.5 seconds. Pathological examinations were performed 4 weeks postsurgery in all dogs, and no histological abnormalities related to aerosolized indocyanine green administration were observed at the anastomosis sites. LIMITATIONS: The leak points were surgically created and did not occur naturally. CONCLUSIONS: Visualization of air leaks at the sites of rectal anastomosis was laparoscopically achievable by administering aerosolized indocyanine green transanally into the rectum in our canine model. This novel fluorescent leak test could be a valid alternative to established methods.

Effective and Secure Closure after Duodenal Endoscopic Submucosal Dissection: Combination of Endoscopic Ligation with O-Ring Closure and Over-the-Scope Clip.

Duodenal endoscopic submucosal dissection (ESD) is associated with high incidences of intraoperative complications and delayed adverse events (AEs). Delayed AEs can be reduced by closing the post-ESD defects. We developed a new method of closure after duodenal ESD, combining endoscopic ligation with O-ring closure (E-LOC) with an over-the-scope clip (OTSC) (Band OTSC; B-OTSC). Here, we conducted a single-center, retrospective, observational study to investigate the efficacy and safety of the B-OTSC method for preventing delayed AEs in patients undergoing duodenal ESD. The study included nine patients with superficial nonpapillary duodenal epithelial tumors who underwent ESD and were closed with B-OTSC from February 2021 to February 2023. There were no delayed AEs (0%), the mean (± standard deviation) closure time was 53 ± 21.6 min, the complete closure rate was 100%, and the mean hospital stay was 7.8 ± 1.8 days. The sustained closure rates at postoperative days 3 and 7 were 88.9% and 88.9%, respectively. The historical analysis indicated a significant difference in cost between B-OTSC and conventional OTSC (p < 0.01). In conclusion, B-OTSC was a safe, secure, and cost-effective method of closure after duodenal ESD, even in patients with post-ESD defects of more than half the circumference.

Does an Extraoral Suction Device Reduce Aerosol Generation and Prevent Droplet Exposure to the Examiner during Esophagogastroduodenoscopy?

Esophagogastroduodenoscopy (EGD) is an aerosol-generating procedure. A major challenge in the COVID-19 era is how to prevent the spread of aerosols and droplets in endoscopic units. We evaluated the effectiveness of an extraoral suction device in preventing indoor aerosol diffusion and droplet exposure for examiners. The study involved 61 patients who underwent EGD at our institution from 1 February to 31 March 2022. To determine whether aerosol spread increases before or after EGD examination with an extraoral suction device located in front of the patient's mouth, aerosols of 0.3, 0.5, 1, 3, 5, and 10 µm were measured with a handheld particle counter. The degree of contamination of the plastic gowns on the examiners was assessed using the rapid adenosine triphosphate test. The extraoral suction device significantly reduced the diffusion of large particles (3, 5, and 10 µm) after finishing the EGD examination. However, the diffusion of small particles (0.3 and 0.5 µm) was significantly increased. This extraoral suction device was effective in reducing large particle diffusion during EGD examination but was limited for minimizing small particle diffusion or droplet exposure to the examiner.

Comparison of endoscopic closure versus non-closure for post-gastric endoscopic submucosal dissection artificial floor in antithrombotic therapy: a propensity score-matched analysis.

Background: The management of delayed bleeding after gastric endoscopic submucosal dissection (ESD) is currently an important issue because of recent increases in the number of patients on antithrombotic therapy. Artificial ulcer closure has been shown to prevent delayed complications in the duodenum and colon. However, its effectiveness in cases involving the stomach remains unclear. In this study, we aimed to determine whether endoscopic closure reduces post-ESD bleeding in patients undergoing antithrombotic therapy. Methods: We retrospectively analyzed 114 patients who had undergone gastric ESD while on antithrombotic therapy. The patients were allocated to one of 2 groups: a closure group (n=44) and a non-closure group (n=70). Endoscopic closure had been performed using multiple hemoclips or using the endoscopic ligation with O-ring closure method after coagulation of exposed vessels on the artificial floor. Propensity score matching resulted in 32 pairs of patients (closure vs. non-closure 32:32). The primary outcome was post-ESD bleeding. Results: The post-ESD bleeding rate was significantly lower in the closure group (0%) than in the non-closure group (15.6%) (P=0.0264). There were no significant differences between the 2 groups regarding white blood cell count, C-reactive protein, maximum body temperature, or scores on a verbal rating scale that assesses the degree of abdominal pain. Conclusion: Endoscopic closure may contribute to decreasing the incidence of post-ESD gastric bleeding in patients undergoing antithrombotic therapy.

Comparison of Needle Knife versus Scissors Forceps for Colorectal Endoscopic Submucosal Dissection: A Prospective Randomized Study.

BACKGROUND AND AIM: To evaluate the efficacy and safety of a grasping-type knife, called Clutch Cutter (CC), for colorectal endoscopic submucosal dissection (C-ESD). METHODS: This was a randomized prospective study. Patients who underwent C-ESD for colorectal neoplasms >20 mm and <50 mm in size were enrolled, dividing into two groups: ESD using needle type of dual knife alone (D-group) and circumferential incision using dual knife followed by submucosal dissection using CC (CC-group). The primary outcome was the self-completion rate. The secondary outcomes were intraoperative complication rate, procedure time, and en bloc resection rate. RESULTS: A total of 45 patients were allocated to the D-group and 43 to the CC-group were allocated. The self-completion rate was higher in the CC-group (87% [39/45] vs. 98% [42/43]). All of the six patients with an incomplete procedure in the D-group were completely resected with CC use. The intraoperative complication rate was not significant in either group (D vs. CC: 2% vs. 0%). The mean procedure time was significantly shorter in the D-group than that in the CC-group (62.0 vs. 81.1 min; p = 0.0036). The en bloc resection rate was 100% in the D-group and 98% in the CC-group. CONCLUSIONS: While dual knife use is superior to CC in terms of time efficiency, the use of CC may be a safe and efficacious option for achieving complete C-ESD.

Endoscopic Ligation with O-Ring Closure for Mucosal Defects after Rectal Endoscopic Submucosal Dissection: A Feasibility Study (with Video).

INTRODUCTION: Mucosal defect closure after colorectal endoscopic submucosal dissection (ESD) may prevent post-ESD adverse events. Delayed bleeding is a particular concern in the rectum due to the presence of numerous blood vessels. However, rectal defect closure often fails due to the thick rectal wall. This study aimed to examine the feasibility of our newly developed endoscopic ligation with O-ring closure (E-LOC) for defects after rectal ESD. METHODS: This was a prospective observational study conducted at a single institution. After excluding 2 patients with tumors mostly extending into the anal canal, the study cohort comprised 30 consecutive patients who underwent ESD of rectal neoplasms between July 2020 and July 2021. E-LOC using an endoscopic variceal ligation device was performed for closing mucosal defects after rectal ESD. The primary outcome was the complete closure rate. The secondary outcomes were the delayed bleeding rate, E-LOC procedure time, sustained closure rates on postoperative day (POD) 3, and E-LOC-associated complications. RESULTS: Complete closure of the defect (median defect size 29.0 mm) was successfully achieved in 24 cases (80%). Delayed bleeding occurred in one case with incomplete closure (3.3%). The median E-LOC procedure time was 25.5 min (interquartile range, 20.0-30.0 min). The sustained closure rates were 83.3% (20/24) on POD 3 in the 24 cases with complete closure. No E-LOC-associated complications occurred. DISCUSSION/CONCLUSIONS: E-LOC was feasible for defect closure after rectal ESD, and probably led to a decreased incidence of delayed bleeding.

Comparison of purse-string suture versus over-the-scope clip for gastric endoscopic full-thickness closure: traction and leak pressure testing in ex vivo porcine model.

BACKGROUND: The recently developed endoscopic full-thickness resection technique requires reliable closure. The main closure methods are the purse-string suture (PSS) technique and over-the-scope clip (OTSC) technique; however, basic data on the closure strength of each technique are lacking. This study was performed to compare the closure strengths of these two methods in an ex vivo porcine model. METHODS: In the traction test, a virtual 5-cm full-thickness closure line was closed by the following six methods three times each: conventional hemoclips, mucosal PSS, seromuscular PSS, mucosal OTSC, seromuscular OTSC, and surgical suture. The primary endpoint was the tension at the starting point of dehiscence, measured in Newtons (N) by an automatic traction machine. In the leak test, a 15-mm gastric full-thickness defect was closed by PSS or OTSC six times each, and the closed stomach was then pressurized in a water container. The primary endpoint was the leak pressure when air bubbles appeared. The secondary endpoints were the procedure time and presence of complete inverted closure. RESULTS: The mean tension was 2.16, 3.68, 5.15, 18.30, 19.30, and 62.40 N for conventional hemoclips, mucosal PSS, seromuscular PSS, mucosal OTSC, seromuscular OTSC, and surgical suture, respectively. Complete inverted closure was observed for seromuscular PSS, seromuscular OTSC, and surgical suture. The mean leak pressure was 13.7 and 24.8 mmHg in the PSS and OTSC group, respectively (P < 0.01). The mean procedure time was 541 and 169 s in the PSS and OTSC group, respectively (P < 0.01). Complete inverted closure was observed in OTSC alone. CONCLUSION: The OTSC, which allows complete inverted closure, showed greater closure strength than PSS. Considering the size limitation suitable for single OTSC, a therapeutic strategy for closing the larger size is further warranted.

Acceptability of Hybrid Endoscopic Submucosal Dissection Using Multifunctional Snare for Small-sized Gastric Neoplasms: A Prospective Observational Study.

BACKGROUND AND AIMS: The most suitable procedure for resecting small-sized gastric neoplasms remains unclear. Endoscopic mucosal resection leads to non-curative resection owing to slippage of the snare, and technically difficult endoscopic submucosal dissection (ESD) is instrumentally uneconomical. A novel, cost-effective, multifunctional snare called SOUTEN is available as a hybrid ESD (h-ESD) device developed for facilitating ESD. This study aimed to assess the acceptability of h-ESD using the SOUTEN for resecting small-sized gastric neoplasms. METHODS: This was a prospective observational study conducted at our single institution between March 2019 and March 2021. Fifty-seven consecutive patients who underwent h-ESD using SOUTEN for small-sized gastric neoplasms ≤15 mm involving adenoma and tubular-type mucosal carcinoma without ulceration were enrolled. The primary outcome was curative resection rate for h-ESD. Secondary outcomes were the rates of conversion to ESD, rate of total (h-ESD + ESD) curative resection, procedure time, rates of intra-and post- operative complications, and presence of additional knives excluding hemostatic forceps. RESULTS: The curative resection rate of h-ESD was 89.5% (51/57). The total (h-ESD + ESD) curative resection rate was 94.7% (54/57). The mean procedure time was 21.2 (±16.5) minutes. One case of delayed bleeding occurred. Additional knives were applied in two cases. CONCLUSIONS: The cost-efficient h-ESD using SOUTEN can be an acceptable procedure for resecting small- sized gastric neoplasms.

Efficacy of endoscopic ligation with O-ring closure for prevention of bleeding after gastric endoscopic submucosal dissection under antithrombotic therapy: a prospective observational study.

BACKGROUND: We examined the efficacy of a novel endoscopic ligation technique with O-ring closure (E-LOC) to prevent bleeding after gastric endoscopic submucosal dissection (ESD) under antithrombotic therapy. METHODS: This single-center prospective study involved consecutive patients who were taking antithrombotic agents and underwent gastric ESD. E-LOC was performed by anchoring the nylon loop with hemoclips on both defect edges and/or the exposed muscle layer, and using O-ring band ligation around these deployed clips. The primary outcome was post-ESD bleeding rate. Secondary outcomes were complete closure rate, procedure time, sustained closure rate, and complications. RESULTS: 48 patients were finally analyzed. The post-ESD bleeding rate was 0 %, the complete closure rate was 97.9 %, and the mean closure time was 29.9 minutes. The sustained closure rate was 95.8 % at postoperative day 2-3 and 33.3 % at postoperative day 10-11. No complications occurred. CONCLUSION: E-LOC may be an effective option for closing mucosal defects after gastric ESD under antithrombotic therapy. However, the preventive effect on post-ESD bleeding should be further investigated in high risk groups.

Guidewire-assisted over-the-scope clip delivery method into the distal intestine: a case series.

BACKGROUND: The Over-the-scope clip (OTSC) has been recently introduced for multiple purposes, including refractory bleeding, perforation, fistula, and anastomotic dehiscence of the gastrointestinal tract. However, no easy access techniques for delivering OTSCs to distant sites have been described. Therefore, we have developed a simple and safe guidewire-assisted OTSC delivery (GOD) method for use on the distal intestine. This study aimed to investigate the technical feasibility and safety of the method. MATERIAL AND METHODS: Between June 2018 and April 2019, all eight patients who underwent the GOD method were retrospectively examined. The primary outcome was the successful rate of OTSC delivery to the lesion without complications. The secondary outcomes were GOD procedure time, total procedure time, technical and clinical OTSC success rates, and GOD- and OTSC-associated complications. RESULTS: The rate of successful OTSC delivery was 100%. The median procedure time of GOD was 21 min (range 8-29). The median total procedure time was 38.5 min (range 26-41). The technical and clinical success rates of OTSC were 100% and 75% (6/8), respectively. No GOD- or OTSC-associated complications occurred. CONCLUSIONS: The GOD method is a feasible and safe technique for delivering OTSC toward the small and proximal large intestine.

Long-term outcomes of over-the-scope clip for refractory gastrointestinal diseases.

BACKGROUND: The Over-The-Scope Clip (OTSC) can effectively treat refractory gastrointestinal diseases. However, most reports have focused on short-term effectiveness. We examined clinical outcomes of the deployed clips and long-term characteristics. MATERIAL AND METHODS: Of 47 patients with OTSC treatment, 35 with follow-up periods of ≥3 months were retrospectively examined. The indications were 11 bleedings, 17 perforations, and seven fistulas. The observation period was defined as medium-term (3 to <12 months) or long-term (≥12 months). The primary outcome was the clinical success rate without disease recurrence. The secondary outcomes were the complication rate, survival duration, and clip retention rate. RESULTS: The medium- and long-term clinical success rates were 100% during the observation period (median, 44 months; range, 3-78 months). The complication rate was 2.9% (n = 1). The median survival time was 1,634 days for bleeding, 1,757 days for perforation, and 444 days for fistulas. The overall clip retention rates were 56.4%, 38.1%, 30.9%, and 25.9% after one, six, and 12 months and at the final follow-up, respectively. The average clip retention duration was 244 days in bleeding, 656 days in perforations, and 188 days in fistulas. CONCLUSIONS: Regardless of clip detachment, the OTSC can be effective in long-term.

Wafer paper and ring-mounted polyglycolic acid sheet method for shielding artificial gastric floor.

BACKGROUND: The management of postoperative bleeding, after gastric endoscopic submucosal dissection (ESD), has become particularly important because of the recent increase in antithrombotic use. Endoscopic shielding with polyglycolic acid (PGA) sheets has been shown to be effective. However, shrinkage and early displacement of the sheet remain challenges. This study aimed to determine the efficacy and safety of our developed method, named wafer paper and ring-mounted PGA sheet (WaRP). MATERIAL AND METHODS: Twenty-four patients with antithrombotic uptake who underwent the WaRP method following gastric ESD were retrospectively examined. This involved the delivery of a PGA sheet wrapped in wafer paper with ring-thread, and its fixation on the gastric floor using hemoclips. The primary outcome was the technical success rate of the WaRP, and several secondary outcomes were evaluated. RESULTS: The technical success rate of WaRP was 100%. The procedure lasted a mean of 10.5 min (SD 6.7 min). The prevalence of complete retention at follow-up endoscopy was 83.3% (20/24). There were no WaRP-associated complications, but post-ESD hemorrhage occurred in two patients undergoing hemodialysis (8.3%). CONCLUSIONS: The WaRP method is a simple and reliable means of PGA sheet delivery and placement that reduces the incidence of post-ESD hemorrhage.

[A case of adult intussusception in the transverse colon with an advanced ileal Peutz-Jeghers type polyp associated with cancer].

A man in his thirties was admitted to the hospital because of upper abdominal pain. Computed tomography showed intussusception in the ascending and transverse colon. After spontaneous discontinuation, endoscopy revealed a 25-mm 0-I tumor in the ileum. An emergency operation was performed the next day due to intussusception recurrence. The tumor was hyperplastic intestinal epithelium with dendritic smooth muscle fascicles and partly cancerous. The patient had no clinical features of Peutz-Jeghers syndrome. Therefore, the patient was diagnosed with Peutz-Jeghers type polyps based on pathological findings. This case is considered to be a rare case of intussusception in the transverse colon due to Peutz-Jeghers type polyp with canceration.

Clinical Efficacy of Novel Patient-Covering Negative-Pressure Box for Shielding Virus Transmission during Esophagogastroduodenoscopy: A Prospective Observational Study.

Esophagogastroduodenoscopy (EGD) has a high risk of virus transmission during the current coronavirus disease 2019 era, and preventive measures are under investigation. We investigated the effectiveness of a newly developed patient-covering negative-pressure box system (Endo barrier®) (EB) for EGD. Eighty consecutive unsedated patients who underwent screening EGD with EB use were prospectively enrolled. To examine the aerosol ratio before, during, and after EGD, 0.3- and 0.5-µm aerosols were measured every 60 s using an optical counter. Moreover, the degree of contamination of the examiners' goggles and vinyl gowns was assessed before and after EGD using a rapid adenosine triphosphate (ATP) test for simulated droplets. Data were available in 73 patients and showed that 0.3- and 0.5-µm particles did not increase in 95.8% (70/73) and 94.5% (69/73) of patients during EGD under EB. There were no significant differences in the total 0.3- or 0.5-µm particle counts before versus after EGD. The difference in the ATP levels before and after EGD was -0.6 ± 16.6 relative light units (RLU) on goggles and 1.59 ± 19.9 RLU on gowns (both within the cutoff value). EB use during EGD may provide a certain preventive effect against aerosols and droplets, decreasing examiners' exposure to viruses.

White Spot, a Novel Endoscopic Finding, May Be Associated with Acid-Suppressing Agents and Hypergastrinemia.

White globe appearance (WGA) is defined as a microendoscopic white lesion with a globular shape underlying the gastric epithelium and is considered a marker of gastric cancer. We recently reported that endoscopically visualized white spot (WS) corresponding to WGA appeared on the nonatrophic mucosa of patients with acid-suppressing agents (A-SA) use. We evaluated patients undergoing routine esophagogastroduodenoscopy and divided the patients into an A-SA group (n = 112) and a control group (n = 158). We compared the presence of WS in both groups. We also compared WS-positive- (n = 31) and -negative (n = 43) groups within the A-SA group regarding these patients' backgrounds and serum gastrin concentrations. Comparing the A-SA group with controls, the prevalence of WS was significantly higher (31/112 vs. 2/158; p < 0.001). The number of patients with high serum gastrin concentrations was significantly higher in the WS-positive group (18/31) vs. the WS-negative group (5/43) (p < 0.001). Within the A-SA group, the prevalence of WS was also significantly higher in patients taking potassium-competitive acid blockers vs. proton-pump inhibitors (21/31 vs. 10/31, p < 0.001). The WS-positive group had a significantly greater percentage of patients, with a high serum gastrin level (p < 0.001). WS may be associated with hypergastrinemia and potassium-competitive acid blockers.

Pocket Creation and Ring-thread Traction Facilitates Colorectal Endoscopic Submucosal Dissection for Non-experts.

BACKGROUND/AIM: Colorectal endoscopic submucosal dissection (ESD) is a difficult technique. Counter-traction may facilitate the procedure but its efficacy in non-experts remains unclear. We determined the safety and efficacy of pocket creation and ring-thread traction (PRM) for non-expert colorectal ESD. PATIENTS AND METHODS: We retrospectively compared patients who underwent conventional colorectal ESD (C-group, n=50) or PRM (pocket creation, whole-circumferential cutting, ring-thread traction, submucosal dissection; PRM-group, n=48). All procedures were performed by four non-experts, each with ≤40 experiences of colorectal ESD. RESULTS: Procedural time was significantly shorter in the PRM-group compared with the C-group (p=0.007), with less additional device usage (p<0.001). There also tended to be fewer perforation incidents and muscle injuries in the PRM-group. There were no significant differences in en bloc or R0 resection rates between the groups. CONCLUSION: PRM may be a safe, useful, and cost-effective technique for non-experts learning to perform colorectal ESD.