Performance of endoscopic submucosal dissection for undifferentiated early gastric cancer: a multicenter retrospective cohort.

Background and study aims Undifferentiated early gastric cancer (UD-EGC) represents an extended indication for endoscopic submucosal dissection (ESD) based on the existing guidelines. This study evaluated the prevalence of UD-EGC recurrence after ESD, and potentially implicated risk factors. Patients and methods Data from 17 centers were collected retrospectively including demographics, endoscopic and pathological findings, and follow-up data from UD-EGC cases treated by ESD. Patients with incomplete resection or advanced disease were excluded. Descriptive statistics quantified variables and calculated the incidence of recurrence. Chi-square test was applied to assess any link between independent variables and relapse; significantly associated variables were inserted to a multivariable regression model. Results Seventy-one patients were eligible, with 2:1 female to male ratio and age of 65.8 ± 11.8 years. Mean lesion size was 33.5 ± 18.8 mm and the most frequent histological subtype was signet ring-cells UGC (2:1). Patients were followed-up every 5.6 ± 3.7 months with a mean surveillance period of 29.3 ± 15.3 months until data collection. Four patients (5.6%) developed local recurrence 8.8 ± 6.5 months post-ESD, with no lymph node or distal metastases been reported. Lesion size was not associated with recurrence ( P = 0.32), in contrast to lymphovascular and perineural invasion which were independently associated with local recurrence ( P = 0.006 and P < 0.001, respectively). Conclusions ESD could be considered as the initial step to manage UD-EGC, providing at least an "entire-lesion" biopsy to guide therapeutic strategy. When histology confirms absence of lymphovascular and perineural invasion, this modality could be therapeutic, providing low recurrence rates.

Impact of peroral cholangioscopy on the management of indeterminate biliary conditions: a multicentre prospective trial.

BACKGROUND AND AIMS: Single-operator cholangioscopy (SOC) can help diagnose biliopancreatic conditions. The impact of SOC on patient outcome has never been specifically addressed. PATIENTS AND METHODS: Consecutive patients bearing indeterminate biliary strictures (IDBS), or primary sclerosing cholangitis (PSC) with suspected cholangiocarcinoma, were included. Patients with IDBS had at least one previous inconclusive endoscopic retrograde cholangio pancreatography (ERCP) + cytology. Primary endpoint was the difference in adequacy of management planned before and after SOC with regard to final diagnosis obtained after surgery or 24 months follow-up. DESIGN: Prospective open-label multicentre trial. RESULTS: 61 patients were included (IDBS: 48; PSC: 13); 70.5% had a benign lesion (IDBS 66.7%, PSC 84.6%). The management adequacy rate was significantly higher after SOC than before SOC overall (p<10-5), in IDBS (p<0.001) and PSC (p<0.05) patients. SOC induced changes in the management of the majority of patients in all groups (60.3%). The overall sensitivity of combined visual impression and biopsy ranged from 52% to 63.6% depending on investigator or independent expert rating (κ 0.92-0.96), whereas specificity, positive and negative predictive values of SOC were, respectively, 100%, 100% and 83.6%. Patient management observed at the end of follow-up was consistent with that anticipated after SOC in 88.5% overall. CONCLUSION: Despite a moderate sensitivity for the diagnosis of malignancy, SOC has a dramatic impact on the management of patients with IDBS and PSC with suspected carcinoma. Cholangioscopy might be implemented in the workup of selected patients with challenging diagnosis, when a significant impact on outcome (essentially resection vs conservative management) is to be expected.

The expansion of endoscopic submucosal dissection in France: A prospective nationwide survey.

INTRODUCTION: Early reports of endoscopic submucosal dissection (ESD) in Europe suggested high complication rates and disappointing outcomes compared to publications from Japan. Since 2008, we have been conducting a nationwide survey to monitor the outcomes and complications of ESD over time. MATERIAL AND METHODS: All consecutive ESD cases from 14 centers in France were prospectively included in the database. Demographic, procedural, outcome and follow-up data were recorded. The results obtained over three years were compared to previously published data covering the 2008-2010 period. RESULTS: Between November 2010 and June 2013, 319 ESD cases performed in 314 patients (62% male, mean (±SD) age 65.4 ± 12) were analyzed and compared to 188 ESD cases in 188 patients (61% male, mean (±SD) age 64.6 ± 13) performed between January 2008 and October 2010. The mean (±SD) lesion size was 39 ± 12 mm in 2010-2013 vs 32.1 ± 21 for 2008-2010 (p = 0.004). En bloc resection improved from 77.1% to 91.7% (p < 0.0001) while R0 en bloc resection remained stable from 72.9% to 71.9% (p = 0.8) over time. Complication rate dropped from 29.2% between 2008 and 2010 to 14.1% between 2010 and 2013 (p < 0.0001), with bleeding decreasing from 11.2% to 4.7% (p = 0.01) and perforations from 18.1% to 8.1% (p = 0.002) over time. No procedure-related mortality was recorded. CONCLUSIONS: In this multicenter study, ESD achieved high rates of en bloc resection with a significant trend toward better outcomes over time. Improvements in lesion delineation and characterization are still needed to increase R0 resection rates.

Technological review on endoscopic submucosal dissection: available equipment, recent developments and emerging techniques.

Endoscopic submucosal dissection (ESD) is widely practiced in Japan and the Eastern World and is rapidly expanding in western countries for the management of early malignancies of the upper and lower gastrointestinal tube. In addition, novel therapeutic applications deriving from ESD have emerged including the treatment of achalasia, of submucosal tumors, of diverticula, of strictures and of reflux disease. An ESD procedure necessitates not only skills and specific training, but also familiarization with a vast spectrum of devices (endoscopes, high-frequency generators and their settings, endoknives, hoods, irrigation devices) and techniques (such as countertraction, artificial ulcer closure), that render the procedure faster, more efficient and safer. This technological article gives an overview on current and novel equipment for an ESD and associated techniques.

Temporary placement of fully covered self-expandable metal stents for the treatment of benign biliary strictures.

BACKGROUND: Endoscopic treatment of benign biliary strictures (BBS) can be challenging. OBJECTIVE: To evaluate the efficacy of fully covered self-expandable metal stents (FCSEMS) in BBS. METHODS: Ninety-two consecutive patients with BBS (chronic pancreatitis (n = 42), anastomotic after liver transplantation (n = 36), and post biliary surgical procedure (n = 14)) were included. FCSEMS were placed across strictures for 6 months before endoscopic extraction. Early success rate was defined as the absence of biliary stricture or as a minimal residual anomaly on post-stent removal endoscopic retrograde cholangiopancreatography (ERCP). Secondary outcomes were the final success and stricture recurrence rates as well as procedure-related morbidity. RESULTS: Stenting was successful in all patients. Stenting associated complications were minor and occurred in 22 (23.9%) patients. Migration occurred in 23 (25%) patients. Stent extraction was successful in all but two patients with proximal stent migration. ERCP after the 6 months stenting showed an early success in 84.9% patients (chronic pancreatitis patients: 94.7%, liver transplant: 87.9%, post-surgical: 61.5%) (p = 0.01). Final success was observed in 57/73 (78.1%) patients with a median follow-up of 12 ± 3.56 months. Recurrence of biliary stricture occurred in 16/73 (21.9%) patients. CONCLUSIONS: FCSEMS placement is efficient for patients with BBS, in particular for chronic pancreatitis patients. Stent extraction after 6 months indwelling, although generally feasible, may fail in a few cases.

Endoscopic submucosal dissection for superficial rectal tumors: prospective evaluation in France.

BACKGROUND AND STUDY AIMS: Endoscopic submucosal dissection (ESD) provides a high en bloc resection rate for superficial colorectal tumors. The aims of this study were to assess the feasibility of ESD in France and to evaluate the complete resection rate at 1 year. PATIENTS AND METHODS: Patients with superficial rectal tumors ≥ 10 mm in size were prospectively included in the study at nine French expert centers between February 2010 and June 2012. The study was stopped temporarily because of a high complication rate. Study recruitment resumed following remedial action. RESULTS: A total of 45 patients were included (mean age 67 years; 24 males). The immediate perforation rate was 18 % (n = 8), and salvage surgery was not required. Six patients (13 %) had late bleeding, which was treated endoscopically in five patients and surgically in one patient who had required blood transfusion. The mortality rate was zero. The en bloc resection rate was 64 % (29/45), and the curative R0 resection rate was 53 % (24/45). Three patients (7 %) had an invasive tumor (two sm1, one T2). At 1-year follow-up, endoscopic examinations showed complete resection in 38 /43 patients (88 %). At the end of the study, after the remedial action, the en bloc resection rate had increased from 52 % to 82 %, and the perforation rate had decreased significantly from 34 % to 0 %. CONCLUSIONS: The study reflects the initial prospective experience of ESD in France, and suggests that curative R0 resection rates should increase and complication rates should decrease with experience and corrective actions.

Long-term follow-up of patients undergoing capsule and double-balloon enteroscopy for identification and treatment of small-bowel vascular lesions: a prospective, multicenter study.

BACKGROUND AND STUDY AIMS: Few data are available concerning the long-term outcome of patients treated endoscopically for bleeding small-bowel vascular lesions (SBVL). The aim of this study was to evaluate the risk of rebleeding after endoscopic therapy for SBVLs detected by video capsule enteroscopy (VCE). The secondary aim was to assess risk factors for rebleeding. PATIENTS AND METHODS: A prospective, multicenter study (15 centers) was conducted, involving patients with obscure gastrointestinal bleeding and SBVL on VCE who were treated during double-balloon enteroscopy (DBE). The likelihood of bleeding was defined according to VCE findings, as high or low. RESULTS: A total of 183 patients underwent endotherapy during DBE, and 64 (35 %) had rebleeding during the 1 year follow-up period. Multivariate analysis indicated that cardiac disease (hazard ratio [HR] 2.04, 95 % confidence interval [CI] 1.20 - 3.48; P < 0.01) and the presence of overt bleeding (HR 1.78, 95 %CI 1.07 - 2.97; P = 0.03) at presentation were associated with the risk of rebleeding. The association between chronic renal failure and the risk of rebleeding was close to statistical significance (HR 1.77, 95 %CI 0.94 - 3.33; P = 0.08). Kaplan-Meier analysis suggested that patients treated during DBE for a lesion with low likelihood of bleeding on VCE had higher rebleeding rates than those with a high likelihood of bleeding (HR 1.87, 95 %CI 0.94 - 3.37; P = 0.07). CONCLUSION: Despite long-term remission in most patients, about one-third had rebleeding at 1 year. Independent risk factors for rebleeding were cardiac disease and overt bleeding at original presentation. The lesion characteristics on VCE may be useful to evaluate the bleeding potential of the lesion and may be used for better selection of patients for DBE.

Endoscopic papillectomy for early ampullary tumors: long-term results from a large multicenter prospective study.

BACKGROUND AND STUDY AIMS: Endoscopic papillectomy of early tumors of the ampulla of Vater is an alternative to surgery. This large prospective multicenter study was aimed at evaluating the long-term results of endoscopic papillectomy. PATIENTS AND METHODS: Between September 2003 and January 2006, 10 centers included all patients referred for endoscopic papillectomy and meeting the inclusion criteria: biopsies showing at least adenoma, a uT1N0 lesion without intraductal involvement at endoscopic ultrasound (EUS), and no previous treatment. A standardized endoscopic papillectomy was done, with endoscopic monitoring with biopsies 4 - 8 weeks later where complications were recorded and complementary resection performed when necessary. Follow-up with duodenoscopy, biopsies, and EUS was done at 6, 12, 18, 24 and 36 months. Therapeutic success was defined as complete resection (no residual tumor found at early monitoring) without duodenal submucosal invasion in the resection specimen in the case of adenocarcinoma and without relapse during follow-up. RESULTS: 93 patients were enrolled. Mortality was 0.9 % and morbidity 35 %, including pancreatitis in 20 %, bleeding 10 %, biliary complications 7 %, perforation 3.6 %, and papillary stenosis in 1.8 %. Adenoma was not confirmed in the resection specimen in 14 patients who were therefore excluded. Initial treatment was insufficient in 9 cases (8 carcinoma with submucosal invasion; 1 persistence of adenoma). During follow-up, 5 patients had tumor recurrence and 7 died from unrelated diseases without recurrence. Finally, 81.0 % of patients were cured (95 % confidence interval 72.3 % - 89.7 %). CONCLUSION: Endoscopic papillectomy of selected ampullary tumors is curative in 81.0 % of cases. It must be considered to be the first-line treatment for early tumors of the ampulla of Vater without intraductal invasion.

Comparison of a standard fully covered stent with a super-thick silicone-covered stent for the treatment of refractory esophageal benign strictures: A prospective multicenter study.

BACKGROUND: Some esophageal strictures resist endoscopic treatments. There is a need for new treatments, such as specifically designed stents. OBJECTIVE: Our study sought to compare the results achieved with a standard, fully covered metallic stent (FCMS) and those achieved using a stent designed specifically for benign strictures (BS-FCMS). PATIENTS AND METHODS: The study used a prospective, multicenter, controlled design, with patients recruited from tertiary referral centers. Patients with refractory esophageal strictures were included. Standard FCMS were used in group 1 (N = 24), and BS-FCMS were used in group 2 (N = 17). Patients were followed for 24 months after stent removal. The main outcomes measured were stricture resolution rate, 24 months' recurrence rate and stent-related morbidity. RESULTS: Early stent migrations occurred in one (4.1%) patient from group 1 and five (29.4%) from group 2 (p < 0.05). During esophageal stenting, complications occurred in six patients (25%) in group 1 and six patients (35.3%) in group 2 (p = 0.47), respectively. Fifty percent of complications were attributed to migration. There was no procedure-related morbidity associated with the extraction of the stent. The stricture resolution rate was, respectively, 95.2% in group 1 and 87.5% in group 2 (the difference between the two groups is not significant). During follow-up, stricture recurrence occurred in 15/19 patients (group 1, 79%) and 7/8 patients (group 2, 87.5%; p = 1.0). The median time to recurrence of esophageal stricture was 1.7 months (group 1, 0.6-12 months) and 1 month (group 2, 0.1-6 months). Study limitations include its nonrandomized design. CONCLUSION: The stricture resolution rate was high at the end of the stenting period for both types of stents without any statistical difference between the two groups, but the long-term results were disappointing, with stricture recurring frequently and rapidly in both groups.

Active gastrointestinal bleeding: use of hemostatic forceps beyond endoscopic submucosal dissection.

To the best of our knowledge, this is the first report of the application of hemostatic forceps in active gastrointestinal (GI) bleeding that is not related to endoscopic submucosal dissection. An 86-year-old woman with chronic intake of low-dose aspirin had a Dieulafoy's lesion of the third duodenal portion. Bleeding control with epinephrine injection was unsuccessful. A 60-year-old man presented with a bleeding ulcer in the duodenal bulb. Ten days after combined endotherapy, he had recurrent bleeding from two minimal lesions in the same location. A 66-year-old woman under combined antithrombotic treatment was referred to us for chronic GI bleeding of unexplained origin. Endoscopy revealed active diverticular bleeding in the second duodenal portion. A 61-year-old woman underwent endoscopic mucosal resection of superficial gastric adenocarcinoma, which was complicated with immediate bleeding. In all cases, the blood was washed out using a water-jet-equipped, single-channel gastroscope with a large working channel. The bleeding points were pinched and retracted with hemostatic forceps. Monopolar electrocoagulation was performed using an electrosurgical current generator. Hemostasis was achieved. No complications occurred. In conclusion, hemostatic forceps may be an effective as well as safe alternative approach for active GI bleeding of various origins.

Endoscopic management of a tubular esophageal duplication diagnosed in adolescence (with videos).

BACKGROUND: Esophageal duplication is a rare congenital lesion. Surgery is the standard treatment. Tubular duplication is extremely rare, with esophageal communication in very few cases. OBJECTIVE: The aim of this study was to document the feasibility of the endoscopic management of tubular esophageal duplication. DESIGN: Case report. INTERVENTION: A 14-year-old boy presented with acute dysphagia and acute retrosternal pain. Based on his radiographic and endoscopic findings, a cystic esophageal duplication with an upper esophageal stricture was initially suspected. A laparoscopic gastrostomy was performed. A cyst resection through right thoracoscopy assisted by flexible endoscopy was decided upon. When no extraluminal cystic duplication was found, a tubular duplication was considered and the procedure was abandoned. An endoscopic treatment was performed. A standard endoscope was inserted through an upper esophageal stricture. Two lumens were identified 25 cm from the incisors. A pediatric endoscope was passed through the main one, revealing a thick intraluminal bridge. By using a guidewire, the endoscope's passage into the narrow lumen revealed a distal communication with the esophagus. With the guidewire left in place, the endoscope was reintroduced into the main lumen. A lengthwise incision of the bridge was performed by using a needle knife. At the end of the procedure, an esophageal dilation was performed. Histology confirmed the diagnosis of duplication. RESULTS: The endoscopic incision of the duplication was completed uneventfully. For 11 months, the patient followed a normal diet and experienced no symptoms. LIMITATIONS: Single case. CONCLUSION: To our knowledge, this is the first report of successful endoscopic incision of a total tubular esophageal duplication.

Joystick interfaces are not suitable for robotized endoscope applied to NOTES.

BACKGROUND: NOTES has changed the working environment of endoscopy, leading to new difficulties. The limitations of conventional endoscopes call for the development of new platforms. Robotics may be the answer. MATERIALS AND METHODS: The authors compared human to robotized manipulation of a flexible endoscope into the abdominal cavity, in an animal model. Thirty-two participants were enrolled. Results were analyzed according to the clinical background of the participants: experienced endoscopists, experienced laparoscopists, and medical students. Two single-channel gastroscopes were used. Whereas one was not modified, the other had the handling wheels replaced by motors controlled through a computer and a joystick. A NOTES transgastric approach was used to access the peritoneal cavity. The time to touch previously positioned intra-abdominal numbered plastic targets was recorded 3 times with each endoscope. RESULTS: Mean time to complete the tasks was significantly shorter using the conventional endoscope (2.71 vs 6.96 minutes, P < .001). When the robotized endoscope was used, the mean times of endoscopists (7.42 minutes), laparoscopists (6.84 minutes), and students (6.77 minutes) were statistically identical. No differences were found between laparoscopists and students in both techniques. DISCUSSION: Applying robotics to a flexible endoscope fails to enhance ability to move into the abdominal cavity, partly because of the interface. To overcome the limitations of endoscope when performing complex NOTES tasks, robotics may be useful, especially to control the instruments and to stabilize the endoscope itself. CONCLUSION: Robotized endoscope with joystick interface is not sufficient to enhance immediate intuitiveness of flexible endoscopy applied to NOTES.

Supplementation of endoscopic submucosal dissection with sentinel node biopsy performed by natural orifice transluminal endoscopic surgery (NOTES) (with video).

BACKGROUND: Endoscopic submucosal dissection (ESD) is proving to be effective for the resection of selected early gastric and colon cancers. Its application and appropriateness could be extended if a means of determining lymphatic dissemination without recourse to a conventional operation could be provided. OBJECTIVE: To demonstrate the feasibility of companion sentinel node biopsy (SNB) by natural orifice transluminal endoscopic surgery (NOTES) concurrent with intraluminal ESD in both the sigmoid colon and stomach. DESIGN: Acute porcine model. INTERVENTION: Arbitrarily selected mucosal foci were targeted for combined NOTES-SNB and ESD in the sigmoid and stomach of 2 separate anesthetized animals. NOTES peritoneal access was obtained either transgastrically or transvaginally. A second intraluminal endoscope was passed either orally or rectally, as appropriate, to perform submucosal injection for lymphatic mapping under direct vision of the NOTES endoscope. This endoscope then identified the first-order draining (sentinel) nodes and allowed their excisional biopsy. The sigmoid was retracted by magnetic assistance as required, while torque of an intraluminal gastroscope manipulated the stomach. After retrieval of the nodes, 1-cm and 1.5-cm specimens were resected from the sigmoid and stomach, respectively, by conventional ESD. At procedure end, necropsy was performed. RESULTS: All sentinel nodes were identified, underwent biopsy, and were retrieved intact. ESD was subsequently readily performed without complication. SNB completeness and ESD quality were confirmed postprocedure. LIMITATIONS: Experimental model with limited sample size. CONCLUSIONS: Although not yet appropriate for human use, this proposal merits serious consideration as a potential means of augmenting the effectiveness and appropriateness of ESD techniques for GI neoplasia.