Elisa Chiara Ferrara

Safety of cold polypectomy for <10mm polyps at colonoscopy: a prospective multicenter study.

BACKGROUND Cold polypectomy techniques (without electrocautery) by means of biopsy forceps or snare are widely adopted for the removal of subcentimetric polyps. However, few data are available on the safety of this approach. The aim of this study was to assess the safety of cold polypectomy for subcentimetric polyps, as well as the rate of advanced neoplasia in these lesions. PATIENTS AND METHODS In a prospective multicenter trial, consecutive patients with at least one < 10-mm polyp at colonoscopy were prospectively included. All of the < 10-mm polyps detected within the study period were removed by cold polypectomy. The rates of immediate or delayed bleeding and other complications were assessed at 7 and 30 days after cold polypectomy by telephone calls. The rate of advanced histology was also assessed. Predictive variables of postpolypectomy bleeding or advanced neoplasia were identified by multivariate analysis. RESULTS A total of 1015 < 10-mm polyps in 823 patients (15.5 % on antiplatelet agents) were removed. Of these, 822 (81 %) were ≤ 5 mm and 193 (19 %) were 6 - 9 mm. Immediate postpolypectomy bleeding occurred in 18 patients, corresponding to a per-patient and per-polyp bleeding rate of 2.2 % (95 % confidence interval [CI] 1.2 % - 3.2 %) and 1.8 % (95 %CI 1 % - 2.6 %), respectively. Therapy with antiplatelet agents (odds ratio [OR] 4; 95 %CI 1.5 - 10.6) and larger polyp size (OR 2; 95 %CI 1.1 - 6.9) were independent predictors of bleeding. Bleeding was successfully treated by endoscopic hemostasis in all cases and required no further medical intervention. Advanced neoplasia prevalence in polyps ≤ 5 mm was as high as 8.7 %. CONCLUSIONS The results from this study showed the high safety of a cold polypectomy approach for subcentimetric polyps. This was due to the low rate of postpolypectomy bleeding and to the high efficacy of endoscopic hemostasis in its treatment. The high rate of advanced neoplasia in polyps ≤ 5 mm should prompt some caution on the management of these lesions following detection at computed tomography colonography or colon capsule endoscopy.

High efficacy of endoscopic submucosal dissection for rectal laterally spreading tumors larger than 3 cm

BACKGROUND Endoscopic submucosal dissection (ESD) was recently developed to allow en bloc resection of early neoplasia of the GI tract, including colorectal neoplasia. The endoscopic technique is technically demanding and not yet standardized, and new devices are needed. OBJECTIVE This study aimed to evaluate the efficacy and safety of a new device that combines the functions of injection and cutting. DESIGN Prospective, pilot, single-arm study. METHODS Consecutive patients with rectal laterally spreading tumors (LSTs) 3 cm or larger unsuitable for en bloc resection were enrolled. ESD was performed with a new device that allows cutting and coagulation as well as a needleless, tissue-selective mucosal and submucosal elevation through an axial water-jet channel. MAIN OUTCOME MEASUREMENT The primary endpoint of the study was the en bloc resection rate achieved with ESD in a Western hospital setting. RESULTS Overall, ESD was attempted in 40 consecutive patients (27 male, mean age 65.3 years) with rectal LSTs larger than 3 cm (72.5% LSTs, nongranular type, 5% depressed type, 22.5% protruding type). The mean lesion size was 46.8 ± 10.9 mm (range 33-80 mm). The mean procedure time was 86.1 ± 35.5 minutes (range 40-190 minutes). The en bloc resection rate was 90% (36/40). In the remaining patients, resection was completed with a piecemeal approach. The rate of curative resection (R0) was 32 of 40 LSTs (80%). Two patients with submucosal invasion were referred for surgery. Perforation occurred in 1 patient (2.5%), which was managed conservatively. Postoperative bleeding occurred in 2 patients (5%) and was treated by endoscopic hemostasis. LIMITATIONS Single-center study with a relatively small number of patients. CONCLUSIONS ESD is a safe and effective method to provide en bloc and curative resection of large rectal LSTs. The operating time and adverse event rate were comparable to those of previously published data from Japanese experts.

Balanced propofol sedation administered by nonanesthesiologists: The first Italian experience

AIM To assess the efficacy and safety of a balanced approach using midazolam in combination with propofol, administered by non-anesthesiologists, in a large series of diagnostic colonoscopies. METHODS Consecutive patients undergoing diagnostic colonoscopy were sedated with a single dose of midazolam (0.05 mg/kg) and low-dose propofol (starter bolus of 0.5 mg/kg and repeated boluses of 10 to 20 mg). Induction time and deepest level of sedation, adverse and serious adverse events, as well as recovery times, were prospectively assessed. Cecal intubation and adenoma detection rates were also collected. RESULTS Overall, 1593 eligible patients were included. The median dose of propofol administered was 70 mg (range: 40-120 mg), and the median dose of midazolam was 2.3 mg (range: 2-4 mg). Median induction time of sedation was 3 min (range: 1-4 min), and median recovery time was 23 min (range: 10-40 min). A moderate level of sedation was achieved in 1561 (98%) patients, whilst a deep sedation occurred in 32 (2%) cases. Transient oxygen desaturation requiring further oxygen supplementation occurred in 8 (0.46%; 95% CI: 0.2%-0.8%) patients. No serious adverse event was observed. Cecal intubation and adenoma detection rates were 93.5% and 23.4% (27.8% for male and 18.5% for female, subjects), respectively. CONCLUSION A balanced sedation protocol provided a minimalization of the dose of propofol needed to target a moderate sedation for colonoscopy, resulting in a high safety profile for non-anesthesiologist propofol sedation.

Endoscopic submucosal dissection of early gastric neoplastic lesions: A western series

Objective Endoscopic submucosal dissection (ESD) has been found to be effective and safe for endoscopic removal of early gastric neoplasia in large Asian series. However, few data are available on the use of ESD in western countries. We assessed the efficacy of ESD performed in patients with early gastric neoplastic lesions. Methods We analyzed prospectively collected data of consecutive patients who underwent the ESD procedure for gastric neoplasia at a single Italian center. Procedure-related outcomes, including complete histological resection rate (i.e. R0 resection), immediate and late complication rate, procedure-related mortality, and follow-up were evaluated. Results Forty-two patients underwent gastric ESD. The en-bloc removal of lesions was successful in all cases, whereas R0 was achieved in 39 (92.8%) patients. A bleeding episode was observed in three (7.1%) patients, which was successfully managed by endoclip positioning. No perforations and procedure-related deaths were observed. The median follow-up period was 19 months (range: 9−53). A small residue of adenomatous lesion and a recurrent dysplastic lesion were removed by endoscopic mucosal resection in two (5%) patients. Conclusion Our data are comparable with those of larger Asian series. Use of ESD for removal of gastric neoplastic lesions should be implemented in western countries.

Endo-sponge therapy for management of anastomotic leakages after colorectal surgery: A case series and review of literature

BACKGROUND Endo-sponge treatment is a novel approach to manage selected patients with anastomotic leakage following colorectal surgery. However, the available data are still scanty. AIMS To evaluate the efficacy and safety of the endo-sponge therapy in a large series, and to perform a review of the current evidence concerning such a treatment. METHODS Consecutive patients diagnosed with partial colonic anastomotic leakage managed with endo-sponge placement were enrolled. The endo-sponge system was changed every 48-72 h as outpatient, until to cavity closure. Literature review was performed for pooled-data analysis. RESULTS Twenty-five patients were enrolled, including 13 (52%) with diverting ileostomy. Following endo-sponge applications (median sessions: 9, range: 1-39; median treatment duration: 4 weeks, range: 1-32), a complete healing was achieved in 22 (88%) patients. Three (12%) patients developed a major complication (1 uretheric fistula, 1 ileal fistula, and 1 pararectal abscess), all successfully treated by surgery. Ileostomy closure was achieved in 11 (84.6%) patients. No mortality related to the procedure was observed. Overall, 174 patients treated with endo-sponge were reported in literature. By considering data of the larger 7 studies, a complete healing of presacral cavity was achieved in 131 (94.3%) out of 149 patients. CONCLUSIONS Our relatively large series of patients confirmed the efficacy, tolerability, and an acceptably low complication rate of endo-sponge therapy for colorectal anastomosis leakage treatment.

Endoscopic Management of Benign Esophageal Ruptures and Leaks

Opinion statementEsophageal leaks (EL) and ruptures (ER) are rare conditions associated with a high risk of mortality and morbidity. Historically, EL and ER have been surgically treated, but current treatment options also include conservative management and endoscopy. Over the last decades, interventional endoscopy has evolved as an effective and less invasive alternative to primary surgery in these cases. A variety of techniques are currently available to re-establish the continuity of the digestive tract, prevent or treat infection related to the leak/rupture, prevent further contamination, drain potential collections, and provide nutritional support. Endoscopic options include clips, both through the scope (TTS) and over the scope (OTS), stent placement, vacuum therapy, tissue adhesive, and endoscopic suturing techniques. Theoretically, all of these can be used alone or with a multimodality approach. Endoscopic therapy should be combined with medical therapy but also with percutaneous drainage of collections, where present. There is robust evidence suggesting that this change of therapeutic paradigm in the form of endoscopic therapy is associated with improved outcome, better quality of life, and shortened length of hospital stay. Moreover, recent European guidelines on endoscopic management of iatrogenic perforation have strengthened and to some degree regulated and redefined the role of endoscopy in the management of conditions where there is a breach in the continuity of the GI wall. Certainly, due to the complexity of these conditions and the variety of available treatment options, a multidisciplinary approach is strongly recommended, with close clinical monitoring (by endoscopists, surgeons, and intensive care physicians) and special attention to signs of sepsis, which can lead to the need for urgent surgical management. This review article will critically discuss the literature regarding endoscopic modalities for esophageal leak and perforation management and attempt to place them in perspective for the physician.

Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial

BACKGROUND Dilation is the standard of care for recurrent benign esophageal strictures (BES). Biodegradable stents may prolong the effect of dilation and reduce recurrences. Efficacy and safety of dilation and biodegradable stent placement early in the treatment algorithm of recurrent BES were compared. METHODS This multicenter, randomized study enrolled patients with BES treated with previous dilations to ≥ 16 mm. The primary end point was number of repeat endoscopic dilations for recurrent stricture within 3 and 6 months. Secondary outcomes through 12 months included safety, time to first dilation for recurrent stricture, dysphagia, and level of activity. RESULTS At 3 months, the biodegradable stent group (n = 32) underwent significantly fewer endoscopic dilations for recurrent stricture compared with the dilation group (n = 34; P < 0.001). By 6 months, the groups were similar. The number of patients experiencing adverse events was similar between the groups. Two patients in the biodegradable stent group died after developing tracheoesophageal fistulas at 95 and 96 days post-placement; no deaths were attributed to the stent. Median time to first dilation of recurrent stricture for the biodegradable stent group was significantly longer (106 vs. 41.5 days; P = 0.003). Dysphagia scores improved for both groups. Patients in the biodegradable stent group had a significantly higher level of activity through 12 months (P < 0.001). CONCLUSION Biodegradable stent placement is associated with temporary reduction in number of repeat dilations and prolonged time to recurrent dysphagia compared with dilation. Additional studies are needed to better define the exact role of biodegradable stent placement to treat recurrent BES.

Cost analysis and outcome of endoscopic submucosal dissection for colorectal lesions in an outpatient setting

BACKGROUND AND STUDY AIMS Endoscopic submucosal dissection (ESD), a minimally invasive treatment for early gastrointestinal (GI) cancer, is considered challenging and risky in the colorectum. As such, most patients undergoing ESD are hospitalized due to the perceived increased risk of adverse events. The aim of this study was to compare the costs, safety and efficacy of colorectal-ESD in an outpatient vs inpatient setting in a tertiary level center. METHODS This is a retrospective study on consecutive patients admitted for colorectal-ESD. Patients were divided into outpatients (Group-A, same-day discharge), and inpatients (Group-B, admitted for at least one night). Data on overall costs, outcomes and adverse events were assessed for each group. RESULTS A total of 136 patients were considered. Fourteen were excluded because ESD was not performed due to intraprocedural suspicion of invasive cancer. Eighty-three patients were treated as outpatients (Group-A, 68%) and 39 (Group-B, 32%) were hospitalized. R0-rate was 90.4% in Group-A and 89.7% in Group-B(P = 0.98). One perforation occurred in Group-A (1.2%) and 2 in Group-B(5.1%, P = 0.2). Mean Length of stay (LOS) was 1 day for outpatients and 3.3 days for inpatients. Management of Group-A as outpatients produced a cost savings of 941€ on average per patient. CONCLUSIONS Outpatient colorectal-ESD is a feasible, cost-effective strategy to manage superficial colorectal tumors with outcomes comparable to inpatient colorectal-ESD. By using proper selection criteria, outpatient ESD could be considered the first-line approach for most patients.

Self-Expanding Metal Stents for the Treatment of Post-Surgical Esophageal Leaks: A Tertiary Referral Center Experience

Background/Aims: The study aimed to evaluate the effectiveness and safety of self-expanding metal stents (SEMS) in the management of post-surgical esophageal leaks. Methods: Retrospective data of consecutive patients with a post-surgical esophageal leak treated by means of a metal stent between January 2008 and December 2014 at the Humanitas Research Hospital (Milan, Italy) were extracted from a prospectively maintained register of SEMS used for benign indications, such as post-surgical benign esophageal strictures and/or leaks. The primary outcome of the study was to assess the rate of successful leak closure and to identify the variables associated with its achievement. As a secondary outcome, we evaluated the overall safety of SEMS placement and the efficacy and safety for different types of SEMS in this specific setting of patients. Leak resolution was documented with endoscopic and/or imaging studies. In the case of leak persistence, further attempts of esophageal stenting were carried out at the discretion of both endoscopists and surgeons. Results: A total of 49 patients were included in the study (men 41 of 49, 83.7%, mean age 62.4 ± 11.9). One patient was excluded from analysis, because of death 1 day after stent insertion due to worsening of pre-existing mediastinitis. A total number of 82 stents were placed (mean number of stents per patient: 1.7) in 49 patients: 35 patients (71.4%) received a partially covered SEMS (PCSEMS) as the first stent positioned, while the remaining 14 (28.6%) received a fully covered SEMS (FCSEMS); but 1 patient (2%) died following stent insertion; therefore, data regarding therapeutic success were available for 48 patients. Stents were left in place for a mean period of 21.9 ± 15.2 days. Leak closure after the first stent placement was achieved in 22 of 48 (45.8%) patients. Of the 26 patients with failure of index stent placement, 18 patients underwent further stenting attempts (69.2%), and secondary closure of leak was achieved in 7 (38.9%) of these 18 patients. Thus, the overall success rate was 60.5% (29 of 48). On the basis of stent type, the success rate was 57.1% (8 of 14) for FCSEMS and 64.7% (22 of 34) for PCSEMS. Logistic regression analysis did not find any significant association between successful leak closure and analyzed variables. Overall mortality was 13.0%. Complication rate was 38.8% (19 of 49 patients). Conclusion: The use of SEMS is an effective and safe option for post-surgical esophageal leaks, with no evidence of any significant influence of stent type on outcome.