A Pilot Study Investigating the Safety and Feasibility of Endoscopic Dilation Using a Radial Incision and Cutting Technique for Benign Strictures of the Small Intestine: A Study Protocol

Abstract BackgroundSmall benign intestinal stenosis is usually treated by endoscopic balloon dilation (EBD) or surgery. Although, EBD and surgery are able to resolve the stenosis in most case, they are associated with several problems such as insufficient dilation and surgical stress, respectively. On the contrary, a novel approach called radial incision and cutting (RIC) is reported to have several benefits when compared to EBD and surgery. We can currently adopt RIC only for the strictures in the colon or terminal ileum and not for those stenotic lesions present further in the small intestine where balloon-assisted endoscopy is utilized, because long-type electric knife is currently not approved for use in Japan. We will herein conduct a pilot study to investigate the safety and feasibility of RIC for treating the benign stenoses of the small intestine using the long-type electric knife.Methods This will be a single-center, single-arm, interventional trial. The major criteria for inclusion will be age ranging from 20 to 80 years and the presence of benign stenosis in the small intestine. We will perform RIC in 10 participants. The primary outcome is the safety of this procedure, which will be assessed by measuring the frequency of adverse events of special interest. The secondary outcomes will be technical success rate, improvement in subjective symptoms, procedure time, and duration of hospitalization.DiscussionThis pilot study will provide useful information that will aid in adopting RIC for treating the benign strictures present in the small intestine. Trial registration jRCT Identifier, jRCTs022200040. Registered on 1 March 2021.URL: https://jrct.niph.go.jp/re/reports/detail/11533

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Balloon enteroscopy-assisted radial incision and cutting method for refractory hepaticojejunostomy anastomotic strictures

Endoscopy ◽

10.1055/a-0838-5557 ◽

2019 ◽

Vol 51 (06) ◽

pp. 566-570

Author(s):

Tadahisa Inoue ◽

Mayu Ibusuki ◽

Rena Kitano ◽

Yuji Kobayashi ◽

Tomohiko Ohashi ◽

...

Keyword(s):

Stent Placement ◽

Clinical Success ◽

Balloon Dilation ◽

Adverse Event Rate ◽

Treatment Technique ◽

Technical Success ◽

Balloon Enteroscopy ◽

Technical Success Rate ◽

Radial Incision ◽

Anastomotic Strictures

Abstract Background Balloon enteroscopy-assisted balloon dilation and temporary biliary stent placement are effective for hepaticojejunostomy anastomotic strictures (HJAS), but the re-stenosis rates are relatively high. We examined the feasibility and efficacy of a novel treatment technique for refractory HJAS, called balloon enteroscopy-assisted radial incision and cutting (BE-RIC). Methods Between January 2016 and June 2018, 11 patients with refractory HJAS that recurred after balloon dilation and/or stent placement, underwent BE-RIC. We evaluated the technical success, clinical success, adverse events, and re-stenosis rates associated with BE-RIC. Results The technical success rate of BE-RIC was 91 % (10/11). Clinical success was achieved in all patients who underwent technically successful procedures. The procedure-related adverse event rate was 9 % (1/11). No re-stenosis was observed during the follow-up period; 9 patients were followed up for more than 6 months, and of these, 5, 4, and 2 patients were followed up for more than 12, 18, and 24 months, respectively, without re-stenosis. Conclusions BE-RIC for refractory HJAS showed favorable results. BE-RIC might be a useful option for treating refractory HJAS.

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Endoscopic radial incision and cutting for Crohn’s Disease-associated intestinal stricture: a pilot study

Endoscopy International Open ◽

10.1055/a-1027-6921 ◽

2020 ◽

Vol 08 (01) ◽

pp. E81-E86 ◽

Cited By ~ 4

Author(s):

Rintaro Moroi ◽

Hisashi Shiga ◽

Masatake Kuroha ◽

Yoshitake Kanazawa ◽

Kotaro Nochioka ◽

...

Keyword(s):

Crohn’S Disease ◽

Pilot Study ◽

Crohn's Disease ◽

Anastomotic Stricture ◽

Alternative Therapy ◽

Balloon Dilation ◽

Ileocecal Resection ◽

Delayed Bleeding ◽

Intestinal Stricture ◽

Radial Incision

Abstract Background and study aims Intestinal stricture associated with Crohn’s disease (CD) is usually treated by endoscopic balloon dilation (EBD) or stricture plasty. Although EBD is effective and safe for such strictures, refractory stricture after EBD poses a problem. Hence, other novel approaches for these refractory strictures are required. On the other hand, the efficacy of radial incision and cutting (RIC) method for esophageal stricture after esophagogastric surgery is reported. In this pilot study, we adopted the RIC technique for five CD patients with refractory intestinal stricture to dilate their strictures. We conducted the RIC procedure using an electric needle knife with a ceramic tip on the top of the needle. Four cases were of anastomotic stricture after ileocecal resection and the remaining one case was of stricture due to mucosal healing. The RIC procedure was successful for all five patients. Average procedure time was 18.6 minutes. One patient developed delayed bleeding after RIC. There were no cases of perforation. RIC could be an alternative therapy for intestinal stricture associated with CD. Further studies should be conducted to clarify its efficacy and safety.

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P4703Distal radial artery access using slender technique for superfitial femoral artery intervention

European Heart Journal ◽

10.1093/eurheartj/ehz745.1084 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

Z Ruzsa ◽

B Nemes ◽

V Orias ◽

A Csuhajda ◽

P Sotonyi ◽

...

Keyword(s):

Pilot Study ◽

Radial Artery ◽

Femoral Artery ◽

Technical Success ◽

Access Site ◽

Femoral Access ◽

Technical Success Rate ◽

Duration Of Hospitalization ◽

Angiographic Data ◽

Acute Success

Abstract Purpose The purpose of this pilot study was to evaluate the acute success and complication rate of the distal radial artery access for femoral artery intervention. Methods and results The clinical and angiographic data of 195 consecutive cases with symptomatic superficial femoral stenosis, treated via distal radial (DR) or proximal radial (PR) access using 6F sheathless guiding between 2014 and 2018, were evaluated in a pilot study. Secondary access was achieved through the pedal artery. Primary endpoint: major adverse events (MAE), rate of major and minor access site complications. Secondary endpoints: angiographic outcome, procedural factors, cross-over rate to femoral access site, and duration of hospitalization. Overall technical success was achieved in 186 patients (95.4%) with 25/26 (96.1%) success in DR and 161/169 (95.2%) success in PR group (ns). The cross over rate to femoral access site was 3.8% in DR and 4.7% in PR group (ns), while dual (transradial and transpedal) access was used in 9/26 (34.6%) patients in DR and 39/169 (23%) patients in PR group (p<0.05). Stent implantation was necessary in 8/26 (30.7%) cases in DR and in 42/169 (24.8%) cases in PR group (ns). CTO recanalization was performed in the DR and PR group with 94.1% (16/17) and 92.6% (79/81) technical success rate. The mean contrast consumption, fluoroscopy time and procedure time was in the DR and PR group was: 93.4 [78–108]ml vs 120 [108–131]ml, 662 [501–822]vs 769 [671–866]min, and 33.4 [27–39]vs 36.5 [32–40]min (ns), respectively. The rate of access site complications in the DR and PR group was 0% and 4.7% (0% major, 4.7% minor) (p p<0.001), respectively. The cumulative incidence of MAE at 3 months in the DR and PR group was 3.8% vs 10.6% (p<0.05). Conclusion Femoral artery intervention can be safely and effectively performed using distal transradial access and distal radial access is associated with lower access site complications.

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Use of Continuous Positive Airway Pressure (CPAP) to Limit Diaphragm Motion—A Novel Approach for Definitive Radiation Therapy for Inoperable Pleural Mesothelioma: A Pilot Study

Biology ◽

10.3390/biology10080711 ◽

2021 ◽

Vol 10 (8) ◽

pp. 711

Author(s):

Assaf Moore ◽

Marc J. Kindler ◽

Aaron Max Allen

Keyword(s):

Pilot Study ◽

Static Field ◽

Normal Lung ◽

Pleural Mesothelioma ◽

Lung Dose ◽

Lung Inflation ◽

Novel Approach ◽

Recent Developments ◽

Ct Simulation ◽

Dose Constraints

Malignant pleural mesothelioma (MPM) is a deadly disease and radiotherapy (RT) plays an important role in its management. Recent developments in technique have made it is possible to deliver RT to MPM in the intact lung. However, it is imperative to reduce normal lung doses. We present a pilot study examining the use of CPAP and VMAT radiotherapy to reduce toxicity when treating MPM, involving three consecutive patients with MPM, not amenable to surgery, who were treated according to Helsinki committee approval. Patients were simulated using four-dimentional CT simulation with the assistance of CPAP lung inflation, then were treated using both IMRT and VMAT techniques. Radiation lung dose was optimized based on accepted lung dose constraints. Patients were followed for toxicity as well as local control and survival. Results: Three patients were treated with CPAP-based IMRT treatment. These patients tolerated the treatment and DVH constraints were able to be met. The comparison plans among the four VMAT arcs and the IMRT static field treatment were able to accomplish the treatment planning objectives without significant advantages with either technique. The treatment combined with CPAP reduced the normal lung dose in MPM patients with intact lungs. This technique is worthy of further investigation.

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Postoperative Albumin Drop Is a Marker for Surgical Stress and a Predictor for Clinical Outcome: A Pilot Study

Gastroenterology Research and Practice ◽

10.1155/2016/8743187 ◽

2016 ◽

Vol 2016 ◽

pp. 1-8 ◽

Cited By ~ 58

Author(s):

Martin Hübner ◽

Styliani Mantziari ◽

Nicolas Demartines ◽

François Pralong ◽

Pauline Coti-Bertrand ◽

...

Keyword(s):

Stress Response ◽

Pilot Study ◽

Clinical Outcomes ◽

Surgical Stress ◽

Major Surgery ◽

Surgical Trauma ◽

Once Daily ◽

Reactive Protein ◽

Estimated Blood Loss ◽

Postoperative Stress

Background. Surgical stress during major surgery may be related to adverse clinical outcomes and early quantification of stress response would be useful to allow prompt interventions. The aim of this study was to evaluate the acute phase protein albumin in the context of the postoperative stress response.Methods. This prospective pilot study included 70 patients undergoing frequent abdominal procedures of different magnitude. Albumin (Alb) and C-reactive protein (CRP) levels were measured once daily starting the day before surgery until postoperative day (POD) 5. Maximal Alb decrease (Alb Δ min) was correlated with clinical parameters of surgical stress, postoperative complications, and length of stay.Results. Albumin values dropped immediately after surgery by about 10 g/L (42.2±4.5 g/L preoperativelyversus33.8±5.3 g/L at day 1,P<0.001). Alb Δ min was correlated with operation length (Pearsonρ=0.470,P<0.001), estimated blood loss (ρ=0.605,P<0.001), and maximal CRP values (ρ=0.391,P=0.002). Alb Δ min levels were significantly higher in patients having complications (10.0±5.4versus6.1±5.2,P=0.005) and a longer hospital stay (ρ=0.285,P<0.020).Conclusion. Early postoperative albumin drop appeared to reflect the magnitude of surgical trauma and was correlated with adverse clinical outcomes. Its promising role as early marker for stress response deserves further prospective evaluation.

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