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The relatively recent adoption of Endoscopic Sleeve Gastroplasty (ESG) amongst obese patients has gained approval within the surgical community due to its notable benefits, including significant weight loss, safety, feasibility, repeatability, and potential reversibility. However, despite its promising clinical outcomes and reduced invasiveness, there is still a lack of standardised procedures for performing ESG. Multiple suture patterns and stitching methods have been proposed over time, yet rational tools to quantify and compare their effects on gastric tissues are absent. To address this gap, this study proposed a computational approach. The research involved a case study analyzing three distinct suture patterns (C-shaped, U-shaped and Z-shaped) using a patient-specific computational stomach model generated from magnetic resonance imaging. Simulations mimicked food intake by placing wire features in the intragastric cavity to replicate sutures, followed by applying a linearly increasing internal pressure up to 15 mmHg. The outcomes facilitated comparisons between suture configurations based on pressure-volume behaviours and the distribution of maximum stress on biological tissues, revealing the U-shaped as the more effective in terms of volume reduction, even if with reduced elongation strains and increased tissues stresses, whereas the Z-shaped is responsible of the greatest stomach shortness after ESG. In summary, computational biomechanics methods serve as potent tools in clinical and surgical settings, offering insights into aspects that are challenging to explore in vivo, such as tissue elongation and stress. These methods allow for mechanical comparisons between different configurations, although they might not encompass crucial clinical outcomes.
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(1) Background: Colorectal cancer (CRC) is a global health concern, particularly among the elderly population. This study aimed to assess the impact of laparoscopic surgery on CRC patients aged ≥80 years. (2) Methods: We conducted a retrospective analysis of prospectively collected data from consecutive CRC patients who underwent surgery at our institution between July 2018 and July 2023. The patients were categorized into three groups: those aged over 80 who underwent laparoscopic surgery (Group A), those aged over 80 who underwent open surgery (Group B), and those under 80 who underwent laparoscopic surgery (Group C). We examined various clinical and surgical parameters, including demographic data, medical history, surgical outcomes, and survival. (3) Results: Group A (N = 113) had shorter hospital stays than Group B (N = 23; p = 0.042), with no significant differences in complications or 30-day outcomes. Compared to Group C (N = 269), Group A had higher comorbidity indices (p < 0.001), more emergency admissions, anemia, low hemoglobin levels, colonic obstruction (p < 0.001), longer hospital stays (p < 0.001), and more medical complications (p = 0.003). Laparotomic conversion was associated with obstructive neoplasms (p < 0.001), and medical complications with ASA scores (p < 0.001). Both the medical and surgical complications predicted adverse 30-day outcomes (p = 0.007 and p < 0.001). Survival analysis revealed superior overall survival (OS) in Group A vs. Group B (p < 0.0001) and inferior OS vs. Group C (p < 0.0001). After a landmark analysis, the OS for patients aged 80 or older and those under 80 appeared to be similar (HR 2.55 [0.75-8.72], p = 0.136). (4) Conclusions: Laparoscopic surgery in very elderly CRC patients shows comparable oncological outcomes and surgical complications to younger populations. Survival benefits are influenced by age, comorbidities, and medical complications. Further prospective multicenter studies are needed in order to validate these findings.
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It is well known by surgeons that patient positioning is fundamental to exposing the organs when performing an operation via laparoscopy, as gravity can help move the organs and facilitate the exposure of the surgical site. But is it also important for endoscopic procedures? This paper examines various types of endoscopic operations and addresses the issue of the patient's position. The patient's position can be changed not only by rotating the patient along the head-toe axis but also by tilting the surgical bed, as is undertaken during laparoscopic surgical procedures. In particular, it is useful to take into account the effect of gravity on lesion exposure, tumour traction during dissection, crushing by body weight, risk of sample drop, risk of damage to adjacent organs, and anatomical exposure for procedures with radiological support. The endoscopist should always keep in mind the patient's anatomy and the position of the endoscope during operative procedures, not limited to considering only intraluminal vision.
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BACKGROUND: Collateral damage to surrounding healthy tissues has been reported in patients who undergo radiation therapy for pelvic malignancies. This study aimed to evaluate the safety, efficacy and cost efficiency of endoscopic diode laser therapy in patients diagnosed with chronic radiation proctitis (CRP). METHODS: The data of 24 patients (median age 78, range 67-90 years) who presented rectal bleeding and were diagnosed with CRP after undergoing high-dose radiotherapy for prostatic cancer and underwent diode laser therapy were evaluated retrospectively. Non-contact fibers were used in the patients who underwent the procedure without sedation in an outpatient setting. RESULTS: The patients underwent a median of two sessions; overall, a mean of 1591 J of laser energy per session was used. No complications were noted during or after the procedures. Bleeding was completely resolved in 21/24 (88%) patients, and two patients showed improvement (96%). It was not necessary to suspend antiplatelet (six patients) or anticoagulant (four patients) therapy during the treatment course. The mean cost per session was EUR 473.4. CONCLUSIONS: The study findings demonstrated that endoscopic non-contact diode laser treatment in CRP patients is safe, effective and cost efficient. For this procedure, antiplatelet and anticoagulant therapy suspension, intraprocedural sedation and hospital admission are not required.
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BACKGROUND: Endoscopic submucosal dissection (ESD) can be used for the en-bloc removal of superficial rectal lesions; however, the lack of a traction system makes the procedure long and difficult in the presence of extensive lesions. CASE SUMMARY: A large polyp occupying 2/3 of the rectal circumference and extending 5 cm in length was removed by ESD with the help of laparoscopic forceps introduced via trans-anal rectoscopic assisted minimally invasive surgery, a disposable platform designed to aid in transanal minimally invasive surgery. Traction of the polyp by forceps during the operation was dynamic, and applied at various points and in various directions. The polyp was removed en-bloc without complications in 1 h and 55 min. A sigmoidoscopy performed 50 d later showed normal healing without polyp recurrence. CONCLUSION: The technique presented here could overcome the issues caused by lack of traction during ESD for rectal lesions.
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The aim of this study was to evaluate the safety and efficacy of the endoscopic sleeve gastroplasty (ESG) procedure. Patients ineligible for bariatric surgery due to comorbidities or low Body Mass Index (BMI) were offered ESG. Gastric tubularization was carried out via multiple multi-bite sutures across the greater curvature of the stomach. The patients underwent a water-soluble swallow test on post-operative day 1 (POD-1) to assess gastric emptying and were placed on a soft diet if upper GI tract function was confirmed. From January 2019 to March 2022, 27 patients underwent ESG: 14 for severe obesity with comorbidities, including liver transplant, end-stage kidney disease, severe cardiovascular and respiratory diseases. The mean BMI before treatment was 36 ± 9 kg/m2. Two patients (7%) who developed gastric bleeding were successfully treated with packed red blood cells (PRBC) transfusions. After a mean follow-up of 18 months, the percentage of total body weight loss (%TBWL) and the percentage of excess weight (%EWL) were 11 ± 7 and 39 ± 27, respectively. The latter was significantly higher in the patients with an initial BMI < 40 kg/m2 (50 vs 22, p < 0.05). The patients whose gastric sleeve extended for more than a third of the length of the stomach (p < 0.05) had better results. ESG was found to be effective and safe in high-risk surgical patients whose initial BMI was (< 40). Studies characterized by larger number of patients and longer follow-up periods will be able to confirm these results.
Subject(s)
Gastroplasty , Humans , Gastroplasty/adverse effects , Obesity/surgery , Treatment Outcome , Weight Loss , Body Mass IndexABSTRACT
Purpose Endoscopic polypectomy to remove gastric hyperplastic polyps in cirrhotic patients is associated to a high risk of postprocedural bleeding. The current study set out to examine the effect of diode laser therapy used to treat this type of polyps in cirrhotic patients. Methods This single-center study retrospectively examined the data of cirrhotic patients with macroscopic bleeding or anemia who underwent diode laser therapy (940 nm wave length, 30-W power setting in continuous mode) to remove histology-confirmed hyperplastic gastric polyps. Results A total of 222 polyps (mean diameter 10 ± 8 mm) were treated in 55 patients who were included in the study. No complications such as bleeding or perforations were reported. After a mean of 5 ± 4 sessions, 31 patients (56%) were completely healed. In 16 patients (29%), there was only a partial response (mean polyp reduction diameter of 64 ± 15%), while 8 (15%) patients did not respond to treatment. Statistically significant better results were noted in the patients who underwent ≥ 2 laser sessions. Hemoglobin levels and number of blood transfusions required were not statistically different after treatment. After a mean study period of 21 ± 17 months, polyp recurrences were noted in 11 patients (20%), but none of the polyps had degenerated. Conclusion Diode laser therapy was found to be a safe treatment for hyperplastic polyps in cirrhotic patients. Due to the presence of others bleeding lesions in cirrhotic patients, this treatment did not have an impact on anemia and transfusion requirements.
Subject(s)
Adenomatous Polyps/complications , Adenomatous Polyps/surgery , Endoscopy , Laser Therapy , Lasers, Semiconductor/therapeutic use , Liver Cirrhosis/complications , Stomach Neoplasms/complications , Stomach Neoplasms/surgery , Aged , Endoscopy/adverse effects , Humans , Laser Therapy/adverse effects , Lasers, Semiconductor/adverse effects , Male , Middle Aged , Recurrence , Retrospective Studies , Treatment OutcomeABSTRACT
PURPOSE: The study aimed to evaluate the feasibility and safety of a new trans-anal rectoscopic-assisted minimally invasive surgery (ARAMIS) platform to treat rectal lesions. METHODS: ARAMIS was first compared with two transanal minimally invasive surgery platforms (SILS Port and GelPOINT Path) on human cadavers. Surgeons with different experience performed running sutures at different distances, at four quadrants, using the three platforms and gave a score to visibility, safety, and maneuverability. ARAMIS was then utilized on patients affected with rectal neoplasia who met the inclusion criteria. Patients and tumor characteristic and results were prospectively collected. The follow-up examinations included proctoscopy at 3, 6, and 12 months. RESULTS: According to surgeons' scores, ARAMIS improves visibility and safety with respect to other platforms for distances beyond 10 cm. The procedure, which lasted an average of 59 min, was successfully carried out in 14 patients. No intraoperative or postoperative complications were reported. The mean tumor size was 3 cm; they were located a mean of 11 cm from the anal verge. Complete removal of the lesion was possible in 13/14 patients. There was one case of adenoma recurrence at follow-up. CONCLUSION: Study results showed that ARAMIS, which is equipped with an adjustable rectoscope, can be considered a safe, effective platform for transanal surgery. The rectoscope protects the rectum during the procedure, a particularly important consideration when proximal rectal lesions are being treated. Further clinical studies are warranted to confirm these encouraging results.
Subject(s)
Rectal Neoplasms , Transanal Endoscopic Surgery , Anal Canal/surgery , Humans , Minimally Invasive Surgical Procedures , Neoplasm Recurrence, Local , Rectal Neoplasms/surgery , Transanal Endoscopic Surgery/adverse effectsSubject(s)
Enterobiasis , Fever/parasitology , Lymphadenitis/parasitology , Pharyngitis/parasitology , Stomatitis, Aphthous/parasitology , Adult , Animals , Child , Child, Preschool , Female , Humans , Male , Middle Aged , Neck , Syndrome , Young AdultABSTRACT
PURPOSE: The study aimed to evaluate the QoL in patients who underwent elective surgery for uncomplicated diverticulitis using a recently developed diverticulitis quality of life questionnaire (DV-QoL). METHODS: All consecutive patients who underwent surgery for uncomplicated diverticulitis or who were hospitalized and treated conservatively for acute uncomplicated diverticulitis episodes in three referral centers, in a 5-year period, were included in the study. The 36-Item Short Form Survey and the DV-QoL were administered to the patients to assess their QoL before and after treatment of diverticular disease. RESULTS: Ninety-seven patients who underwent surgery, 44 patients who were treated conservatively, and 44 healthy volunteers were included in the study. DV-QoL scores correlated with SF-36 scores (p < 0.0001). The surgically treated patients reported a worse quality of life before treatment with respect to the patients treated conservatively (mean 21.12 surgical vs 15.41 conservative, p = 0.0048). The surgically treated patients presented better post-treatment global scores with respect to the conservatively treated patients (mean: 6.90 surgical vs 10.61 conservative, p = 0.0186). Covariance analysis confirmed that the differences between the pre- and post-treatment DV-QoL scores were significantly higher in the surgical (p = 0.0002) with respect to the non-surgical patients. As far as single items were concerned, differences between the two groups were found in the pre- and post-treatment "concerns" and "behavioral changes" DV-QoL items. CONCLUSIONS: Sigmoidectomy reduces concerns about diverticulitis and behavioral changes due to the disease. Quality of life should be considered when referring patients with uncomplicated diverticulitis to surgery. Prospective studies are required to confirm this result.
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Colon, Sigmoid/surgery , Diverticular Diseases/surgery , Laparoscopy , Quality of Life , Aged , Case-Control Studies , Female , Humans , Male , Middle Aged , Reproducibility of Results , Risk Factors , Surveys and Questionnaires , TranslationsSubject(s)
Biliary Fistula/surgery , Common Bile Duct Diseases/surgery , Drainage/methods , Endosonography , Pancreatic Pseudocyst/surgery , Ultrasonography, Interventional , Biliary Fistula/diagnostic imaging , Biliary Fistula/etiology , Common Bile Duct Diseases/diagnostic imaging , Common Bile Duct Diseases/etiology , Female , Humans , Middle Aged , Pancreatic Pseudocyst/complications , Pancreatic Pseudocyst/diagnostic imaging , Surgery, Computer-AssistedABSTRACT
The purpose of this study is to determine the effectiveness of endoscopic diode laser therapy in patients presenting rectal bleeding due to chronic radiation proctitis (CRP). A retrospective analysis of CRP patients who underwent diode laser therapy in a single institution between 2010 and 2016 was carried out. The patients were treated by non-contact fibers without sedation in an outpatient setting. Fourteen patients (median age 77, range 73-87 years) diagnosed with CRP who had undergone high-dose radiotherapy for prostatic cancer and who presented with rectal bleeding were included. Six required blood transfusions. Antiplatelet (three patients) and anticoagulant (two patients) therapy was not suspended during the treatments. The patients underwent a median of two sessions; overall, a mean of 1684 J of laser energy per session was used. Bleeding was resolved in 10/14 (71%) patients, and other two patients showed improvement (93%). Only one patient, who did not complete the treatment, required blood transfusions after laser therapy; no complications were noted during or after the procedures. Study findings demonstrated that endoscopic non-contact diode laser treatment is safe and effective in CRP patients, even in those receiving antiplatelet and/or anticoagulant therapy.
Subject(s)
Endoscopy , Lasers, Semiconductor , Proctitis/surgery , Radiation Injuries/surgery , Aged , Aged, 80 and over , Chronic Disease , Humans , Laser Therapy , Lasers, Semiconductor/adverse effects , Male , Radiation Injuries/etiology , Retrospective StudiesABSTRACT
BACKGROUND: An alternative approach to the treatment of gastroesophageal reflux disease (GERD) has recently been introduced in clinical practice, involving the implantation of a magnetic sphincter augmentation device (MSAD). This "magnetic ring" is implanted laparoscopically around the lower esophageal sphincter to improve its barrier function. The literature is still limited on the midterm results achieved in controlling reflux because the MSAD is a very new procedure. So far, only a few cases of the MSAD causing erosion of the esophagus have been reported. METHODS: We report on two cases of progressive and severe dysphagia after the implantation of an MSAD elsewhere. In both cases, the symptoms were caused by the migration of the device into the esophagus. RESULTS: The devices were removed endoscopically in a single step in both cases, using the Olympus cutter. After 3 months, the first patient had a laparoscopic Nissen fundoplication without any complications and with a good final reflux control. The second only underwent removal of the device, using the same endoscopic approach and again without any complications. CONCLUSIONS: Judging from the literature, MSAD implantation may be an effective way to control GERD, but the method can carry major complications, such as migration of the device into the esophagus (as in the two cases reported here). Endoscopic removal of a device possibly penetrating inside the esophagus is feasible and safe, and may later be followed up with a laparoscopic antireflux procedure without any particular difficulty.
Subject(s)
Deglutition Disorders/etiology , Esophageal Perforation/etiology , Esophageal Sphincter, Lower/surgery , Foreign-Body Migration/complications , Gastroesophageal Reflux/surgery , Prostheses and Implants/adverse effects , Prosthesis Failure , Prosthesis Implantation/adverse effects , Adult , Device Removal/methods , Female , Humans , Laparoscopy/methods , Magnets , MaleABSTRACT
Bariatric surgery includes a variety of procedures that are performed on obese people and aim at decreasing the intake of food and calories. This goal is usually pursued by reducing stomach capacity and/or absorbing capability. Adjustable gastric banding is the most common and successful operation. In general, bariatric surgical procedures are effective, but are often associated with major complications. Surgical procedure and post-surgical conformation of the stomach are usually defined on clinical and surgical basis only. Instead, the optimal configuration should be identified by analyzing the mechanical functionality of the stomach and the surrounding structures, and the relationship between food intake, nutrient adsorption, mechanical stimulation of stomach wall and feeling of satiety. A novel approach to bariatric surgery is required, integrating competences in the areas of biomechanics, physiology and surgery, based on a strong interaction between engineers and clinicians. Preliminary results from coupled experimental and computational investigations are here reported. The analyses aim to develop computational tools for the investigation of stomach mechanical functionality in pre- and post-surgical conformations.
Subject(s)
Bariatric Surgery , Stomach/physiology , Stomach/surgery , Animals , Biophysics , Obesity/surgery , SwineABSTRACT
AIMS: To evaluate the feasibility and safety of Roux-en-Y gastrojejunal bypass procedure using a hybrid NOTES-12 mm trocar technique in a survival porcine model. MATERIAL AND METHODS: The procedure was carried out on ten pigs. Two gastroscopes were introduced through the mouth and through a 12 mm trocar, respectively. A mechanical circular gastro-jejunal anastomosis was created by introducing a stapler after the trocar incision was enlarged. A 21 mm EEA OrVil circular stapler was utilized in the first six pigs and a 25 mm one was used in the other four. All pigs were fed beginning 24 hours after the procedure and were euthanized three weeks later. RESULTS: The procedure was successfully completed in all ten animals. The mean length of the skin incision was 2.5 cm. All pigs survived without complications. Endoscopic inspection detected anastomotic strictures in 5/6 of the 21 mm-stapler and in 0/4 of the 25 mm-stapler anastomoses (p < 0.05). CONCLUSION: Roux-en-Y gastrojejunal bypass using a hybrid NOTES-single 12 mm trocar access technique is a simple and safe procedure in a survival porcine model. Functional results need to be evaluated by further studies.
Subject(s)
Gastric Bypass/methods , Gastroscopes , Natural Orifice Endoscopic Surgery/methods , Surgical Stapling/methods , Anastomosis, Roux-en-Y/methods , Animals , Feasibility Studies , Models, Animal , SwineABSTRACT
The aim of our study was to compare functional outcome and survival in patients who underwent laser therapy (LT) or laser therapy and esophageal stenting (LTES) to palliate inoperable esophageal cancer. Two hundred and twenty-seven consecutive patients who had endoscopic palliation for esophageal cancer were enrolled in this retrospective study. One hundred and sixty-four underwent LT alone and 63 had LTES. A dysphagia score was adopted (0: absolute dysphagia; 1: liquid diet; 2: semisolid diet; 3: free diet). Survival analysis and non parametric statistics were performed. Patients in the LTES group reported a significantly worse dysphagia score than LT patients (p < 0.01). LTES patients more frequently reported difficulty swallowing than LT patients (p < 0.01). No difference between LTES and LT groups was observed in terms of overall survival. Only radiotherapy resulted in a significant predictor of better survival (p = 0.007). Despite a similar survival, LTES is a predictor of a worse functional palliation than LT alone. Radiotherapy was associated with better survival in patients treated with LT. Therefore, these data seem to suggest that a combination of endoscopic LT and external radiotherapy may yield the best results in palliative care of advanced esophageal cancer.
Subject(s)
Deglutition Disorders/surgery , Deglutition/physiology , Esophageal Neoplasms/therapy , Esophagoscopy/methods , Laser Therapy/methods , Neoplasm Staging , Palliative Care/methods , Stents , Aged , Aged, 80 and over , Chemoradiotherapy, Adjuvant/methods , Deglutition Disorders/etiology , Deglutition Disorders/physiopathology , Esophageal Neoplasms/complications , Esophageal Neoplasms/diagnosis , Female , Humans , Male , Middle Aged , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: Surgical training in virtual, animal and cadaver models is essential for minimally invasive surgery. Thiel cadavers are suitable for laparoscopy, but there are few data about the use of embalmed (Tutsch method) and slightly embalmed (Thiel method) cadavers in procedures of Natural Orifice Transluminal Endoscopic Surgery (NOTES), which are usually developed and learned on swine models and fresh frozen cadavers. The aim of this study was thus to assess the use of these cadavers for NOTES approaches. METHODS: The following surgical procedures were evaluated: transanal total mesorectal excision (four cadavers: one Tutsch, two Thiel, one fresh frozen), transanal ileorectal bypass (five cadavers: one Tutsch, three Thiel, one fresh frozen), and transvaginal appendectomy (two Tutsch cadaver). RESULTS: The Thiel method ensured tissue flexibility and consistency suitable for performing the above surgical procedures with good results and without complications, with only a small increase in rigidity with respect to fresh specimens. Cadavers embalmed with higher formalin concentrations (Tutsch method) were more difficult to use, due to high tissue rigidity and resistance of the abdominal wall to pneumoperitoneum, although NOTES accesses were possible. CONCLUSIONS: Thiel cadavers are suitable for transanal/transrectal and transvaginal NOTES approaches, for training surgical residents/specialists and also for surgical research. In minimally invasive surgery (and particularly in NOTES), integration between cadaver (fresh frozen and/or Thiel) and animal models would represent the gold standard, allowing guaranteed knowledge of and respect for human surgical anatomy and correct management of surgery on living subjects. NOTES approaches to human cadavers may also be proposed for the anatomical education of medical students.
Subject(s)
Anatomy/education , Appendectomy/methods , Education, Medical/methods , Natural Orifice Endoscopic Surgery/education , Anal Canal , Cadaver , Feasibility Studies , Female , Humans , Male , VaginaABSTRACT
A novel, minimally invasive diagnostic laparoscopy procedure is described in this report. After positioning a percutaneous trocar and inducing CO2 pneumoperitoneum, a flexible endoscope is introduced through the trocar to inspect intra-abdominal organs, including the surface of the liver, the gallbladder, the stomach, the intestine, the pelvic organs, and free intraperitoneal fluid. Simple procedures such as gathering histological or cytological samples, intraperitoneal lavage, collecting peritoneal fluid for culture, removing adhesions and cyst puncturing are carried out at the endoscopic surgeon's discretion through 1 or 2 working channels. Only a single incision is necessary and, unlike Natural Orifice Translumenal Endoscopic Surgery, visceral iatrogenic perforations are unnecessary.
Subject(s)
Laparoscopy/methods , Aged , Aged, 80 and over , Female , Humans , Laparoscopy/instrumentation , Male , Middle Aged , Pneumoperitoneum, Artificial , SterilizationABSTRACT
BACKGROUND AND OBJECTIVE: The gastrointestinal tract is a primary district of the living organism that shows a complex configuration in terms of biological tissues and structural conformation. The investigation of tissues mechanical functionality in healthy and degenerative conditions is mandatory to plan and design innovative diagnostic and surgical procedures. The aim of this work is to provide some tools for the mechanical analysis of gastrointestinal structures. METHODS: Computational methods allow for evaluating tissues behaviour and interaction phenomena between biomedical devices, prosthetic elements and tissues themselves. The approach envisages a strong integration of expertise from different areas, proceeding from medicine to bioengineering, computational and experimental biomechanics, bio-robotics and materials science. The development of computational models of gastrointestinal structures requires data from histological analysis and mechanical testing, together with engineering and mathematical skills for the definition of constitutive formulations and numerical procedures. RESULTS AND CONCLUSION: An outline of the computational mechanics approach to the investigation of the gastrointestinal tissues and structures response is reported. A general formulation is presented together with specific applications to oesophageal and colonic tissues. Preliminary results from the numerical analysis of interaction phenomena between colonoscopy devices and tissues are also proposed to address to aspects that allow for an evaluation of feasibility and reliability of the proposed approach.
Subject(s)
Computational Biology , Gastrointestinal Tract/physiology , Gastrointestinal Tract/physiopathology , Models, Biological , Bioengineering , Biomechanical Phenomena , Histological Techniques , Humans , RoboticsABSTRACT
OBJECTIVE: To establish the incidence and risk factors for progression to high-grade intraepithelial neoplasia (HG-IEN) or Barrett's esophageal adenocarcinoma (BAc) in a prospective cohort of patients with esophageal intestinal metaplasia [(BE)]. BACKGROUND: BE is associated with an increased risk of BAc unless cases are detected early by surveillance. No consistent data are available on the prevalence of BE-related cancer, the ideal surveillance schedule, or the risk factors for cancer. METHODS: In 2003, a regional registry of BE patients was created in north-east Italy, establishing the related diagnostic criteria (endoscopic landmarks, biopsy protocol, histological classification) and timing of follow-up (tailored to histology) and recording patient outcomes. Thirteen centers were involved and audited yearly. The probability of progression to HG-IEN/BAc was calculated using the Kaplan-Meier method; the Cox regression model was used to calculate the risk of progression. RESULTS: HG-IEN (10 cases) and EAc (7 cases) detected at the index endoscopy or in the first year of follow-up were considered to be cases of preexisting disease and excluded; 841 patients with at least 2 endoscopies {median, 3 [interquartile range (IQR): 2-4); median follow-up = 44.6 [IQR: 24.7-60.5] months; total 3083 patient-years} formed the study group [male/female = 646/195; median age, 60 (IQR: 51-68) years]. Twenty-two patients progressed to HG-IEN or BAc (incidence: 0.72 per 100 patient-years) after a median of 40.2 (26.9-50.4) months. At multivariate analysis, endoscopic abnormalities, that is, ulceration or nodularity (P = 0.0002; relative risk [RR] = 7.6; 95% confidence interval, 2.63-21.9), LG-IEN (P = 0.02, RR = 3.7; 95% confidence interval, 1.22-11.43), and BE length (P = 0.01; RR = 1.16; 95% confidence interval, 1.03-1.30) were associated with BE progression. Among the LG-IEN patients, the incidence of HG-IEN/EAc was 3.17 patient-years, that is, 6 times higher than in BE patients without LG-IEN. CONCLUSIONS: These results suggest that in the absence of intraepithelial neoplastic changes, BE carries a low risk of progression to HG-IEN/BAc, and strict surveillance (or ablative therapy) is advisable in cases with endoscopic abnormalities, LG-IEN or long BE segments.