A feasibility study comparing gel immersion endoscopic resection and underwater endoscopic mucosal resection for superficial nonampullary duodenal epithelial tumors.

BACKGROUND: Although gel immersion endoscopic resection (GIER) is a potential alternative to underwater endoscopic mucosal resection (UEMR) for superficial nonampullary duodenal epithelial tumors (SNADETs), comparisons between the two are currently insufficient. METHODS: 40 consecutive procedures performed in 35 patients were retrospectively reviewed; the primary outcome was procedure time, and the secondary outcomes were en bloc and R0 resection rates, tumor and specimen size, and adverse events. RESULTS: Lesions were divided into GIER (n = 22) and UEMR groups (n = 18). The median (range) procedure time was significantly shorter in the GIER group than in the UEMR group (2.75 [1-3.5] minutes vs. 3 2 3 4 5 6 7 8 9 10 minutes; P = 0.01). The en bloc resection rate was 100 % in the GIER group, but only 83.3 % in the UEMR group. The R0 resection rate was significantly higher in the GIER group than in the UEMR group (95.5 % vs. 66.7 %; P = 0.03). The median specimen size was larger in the GIER group than in the UEMR group (14 mm vs. 7.5 mm; P < 0.001). The tumor size was not significantly different between the groups and no adverse events were observed. CONCLUSIONS: GIER is efficacious and safe to treat SNADETs, although additional studies are needed.

Gel immersion endoscopy-facilitated endoscopic mucosal resection of a superficial nonampullary duodenal epithelial tumor: a novel approach.

Video 1Gel immersion endoscopy-facilitated endoscopic mucosal resection of a superficial nonampullary duodenal epithelial tumor.

The efficacy of prophylactic clip closure of mucosal defects after colorectal endoscopic submucosal dissection on delayed bleeding.

OBJECTIVE: Although prophylactic clip closure after endoscopic mucosal resection may prevent delayed bleeding, information regarding colorectal endoscopic submucosal dissection (CR-ESD) is lacking. Therefore, this study evaluated the effect of prophylactic clip closure on delayed bleeding rate after CR-ESD. MATERIALS AND METHODS: A total of 614 CR-ESD procedures performed in 561 patients were retrospectively reviewed. The primary outcome, which was delayed bleeding rate, was analyzed between the prophylactic clip closure and non-closure groups. Furthermore, the predictors of delayed bleeding were also evaluated. RESULTS: The patients were divided into the clip closure group (n = 275) and non-closure group (n = 339). Delayed bleeding rate was significantly lower in the closure group than in non-closure group (6 cases [2.2%] vs. 20 cases [5.9%], p = .026). The univariate logistic regression analyses revealed that delayed bleeding was significantly associated with laterally spreading tumor-granular-nodular mixed type (LST-G-Mix; odds ratio [OR], 3.77; 95% confidence interval [CI], 1.70-8.34; p = .001). By contrast, prophylactic clip closure was significantly associated with low delayed bleeding rate (OR, 0.36; 95%CI, 0.14-0.90; p = .029). The multivariate logistic regression analyses revealed LST-G-Mix as a significant independent delayed bleeding predictor (OR, 3.25; 95%CI, 1.45-7.32; p = .004), whereas, prophylactic clip closure was identified as a significant independent preventive factor of delayed bleeding (OR, 0.39; 95%CI, 0.15-1.00; p = .049). CONCLUSIONS: Prophylactic clip closure after CR-ESD is associated with low delayed bleeding rate. LST-G-Mix promotes delayed bleeding, and performing prophylactic clip closure may be advisable.

Clinical and therapeutic features and prognostic factors of metastatic colorectal cancer over age 80: a retrospective study.

BACKGROUND: Colorectal cancer (CRC) is one of the most common cancers in the world. The number of elderly patients with CRC increases due to aging of the population. There are few studies that examined chemotherapy and prognostic factors in metastatic colorectal cancer (mCRC) patients aged ≥ 80 years. We assessed the efficacy of chemotherapy and prognostic factors among patients with mCRC aged ≥ 80 years. METHODS: We retrospectively analyzed clinical and laboratory findings of 987 patients newly diagnosed with CRC at Asahi General Hospital (Chiba, Japan) between January 2012 and December 2016. The Kaplan-Meier method was used for the overall survival (OS) and the log-rank test was used to identify difference between patients. A multivariate Cox proportional hazard regression analysis was performed to determine the hazard ratios and 95% confidence intervals (CIs) of prognostic factors among super-elderly patients. RESULTS: In total, 260 patients were diagnosed with mCRC (super-elderly group: n = 43, aged ≥ 80 years and younger group, n = 217, aged < 80 years). The performance status and nutritional status were worse in the super-elderly group than in the younger group. The OS of super-elderly patients who received chemotherapy was worse than that of younger patients (18.5 vs. 28.8 months; P = 0.052), although the difference was not significant. The OS of patients who received chemotherapy tended to be longer than that of those who did not; however, there were no significant differences in OS in the super-elderly group (18.5 vs. 8.4 months P = 0.33). Multivariate analysis revealed that carcinoembryonic antigen levels ≥ 5 ng/mL (hazard ratio: 2.27; 95% CI 1.09-4.74; P = 0.03) and prognostic nutritional index ≤ 35 (hazard ratio: 8.57; 95% CI 2.63-27.9; P = 0.0003) were independently associated with poor OS in the super-elderly group. CONCLUSIONS: Patients with mCRC aged ≥ 80 years had lower OS than younger patients even though they received chemotherapy. Carcinoembryonic antigen and prognostic nutritional index were independent prognostic factors in super-elderly patients with mCRC, but chemotherapy was not. TRIAL REGISTRATION: retrospectively registered.

A prospective multicenter study of endoscopic ultrasound-guided fine needle biopsy using a 22-gauge Franseen needle for pancreatic solid lesions.

BACKGROUND AND AIM: While encouraging data of endoscopic ultrasound (EUS)-guided fine-needle biopsy (EUS-FNB) using a 22-gauge Franseen needle have been reported, large-scale data of per pass and quantitative analyses are still lacking. METHODS: This was a multicenter prospective study of EUS-FNB using the 22-gauge Franseen needle for a pancreatic solid lesion. Cytological and histological analyses per pass were evaluated and semi-quantitative analyses were performed on core tissue and blood contamination. Primary end-point was diagnostic accuracy per session. Prognostic factors were analyzed for diagnostic accuracy, sensitivity, core tissue, and blood contamination. RESULTS: A total of 629 passes were performed in 244 cases at 14 centers between 2018 and 2019. The median tumor size was 29 mm, and the puncture was transduodenal in 43%. The median pass number was 2. Diagnostic accuracy per session, at a first pass, and per pass were 93%, 90%, and 88%. In 198 cases with pancreatic cancer, diagnostic sensitivity per session, at a first pass, and per pass were 94%, 89%, and 89%. The rates of core tissue score of 4 and blood contamination score of 3 were 50% and 47%. The adverse event rate was 1.6%. In the multivariate analysis, tumor size ≤20 mm (odds ratio [OR] of 0.46, P = 0.03), transduodenal puncture (OR of 0.53, P = 0.04), and suction (OR of 0.16, P = 0.01) were associated with lower diagnostic accuracy. CONCLUSIONS: The EUS-FNB using the 22-gauge Franseen needle for pancreatic solid lesions showed high per pass and overall diagnostic accuracy.

Learning curve for endoscopic submucosal dissection of early colorectal neoplasms with a monopolar scissor-type knife: use of the cumulative sum method.

OBJECTIVE: Although scissor-type knives such as the Stag-Beetle (SB) Knife Jr are expected to result in a safe and easy colorectal endoscopic submucosal dissection (CR-ESD), information regarding the learning curve is lacking. Therefore, this study evaluated the learning curve with using SB Knife Jr. MATERIALS AND METHODS: We retrospectively reviewed 507 CR-ESD procedures performed in 464 patients using SB Knife Jr. The primary endpoint was a learning curve to achieve a satisfactory complete resection rate. The secondary endpoints were learning curves to achieve a satisfactory en bloc resection rate, curative resection rate, and resection speed. RESULTS: The complete, en bloc, and curative resection rates were 91.9%, 95.9%, and 84.0%, respectively. Moving average analysis showed that 39 cases were required for a complete resection rate of >80%, 41 for an en bloc resection rate of >90%, and 50 for a curative resection rate of >75%. We divided the procedure into three phases using the cumulative sum method: I, II, and III (cases 1-36, 37-119, and 120-507, respectively). Although we found no significant between-phase differences, the complete resection rate showed an increasing trend in Phase III (83.3 vs. 89.2 vs. 93.3%; p = .099). The en bloc resection rate (91.7 vs. 91.6 vs. 97.2%; p = .047) and resection speed (20.5 vs. 7.2 vs. 6.8 min/cm2; p < .001) were greater in Phase III. Despite the larger specimen size (27.3 vs. 38.2 vs. 40.4 mm; p < .001) and more severe fibrosis (p < .001) in Phase III, the procedure time was shorter (73.8 vs. 57.8 vs. 54.2 min; p = .041). The curative resection rate was not significantly different between phases. CONCLUSIONS: SB Knife Jr enables safe and easy CR-ESD during the introductory period compared to the conventional tip-type knife and has an acceptable learning curve. Therefore, using this knife will encourage the widespread adoption of CR-ESD in Asian general hospitals and non-Asian countries.

Safety and Efficacy of Early Tube Removal Following Percutaneous Transhepatic Gallbladder Drainage: an Observational Study.

BACKGROUND: There are currently no guidelines concerning the advisability and timing of tube removal following percutaneous transhepatic gallbladder drainage (PTGBD). The present study aimed to assess the feasibility and risks of early removal of the PTGBD tube under the scenario of subsiding inflammation, patent cystic and common bile ducts, and absence of intraperitoneal leakage. METHODS: Patient background and outcomes were assessed retrospectively in 701 cases of acute cholecystitis treated with PTGBD. The median times until tube removal and tube dislodgement and the cumulative rates of tube dislodgement were calculated. RESULTS: Tube removal was performed in 275 patients after a median time of 16 days (range: 6 to 213 d); biliary peritonitis was observed in 2 patients following tube removal. Tubes were removed in 8 and 35 patients within 7 and 10 days, respectively. Tube dislodgement was observed in 82 patients after a median time of 12 days (range: 1 to 125 d). CONCLUSION: The present study suggests that drainage tube removal is safe and effective when performed after a short drainage period of 7 to 10 days if the criteria for the removal of the drainage tube were met.

Effects of Early Initiation of Solid Versus Liquid Diet after Endoscopic Submucosal Dissection on Quality of Life and Postoperative Outcomes: A Prospective Pilot Randomized Controlled Trial.

BACKGROUND/AIMS: Feeding recommendations after endoscopic submucosal dissection (ESD) for gastric neoplasms are not established and based on clinical experience. METHODS: This was a prospective pilot randomized controlled trial. Patients undergoing ESD for gastric neoplasms were randomly assigned to solid (n = 50) or liquid diet (n = 50) groups. Beginning the day after hemostasis confirmation until discharge, the solid diet group started on a diet of rice porridge, whereas the liquid diet group started on a liquid diet, with gradual transition to solid food. The primary endpoint was delayed bleeding rate. The secondary endpoints were quality of life (QOL), ulcer-stage, hospital fees, and post-ESD symptoms. RESULTS: Delayed bleeding occurred in the solid diet group (2%) but not in the liquid diet group. The QOL evaluation using European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-STO22 showed better score in the solid diet group. The patients who felt dietary restriction at discharge was of a larger number in the liquid diet group (p = 0.019). More patients experienced appetite loss (p = 0.038), constipation (p = 0.022), and dietary restriction (p = 0.037) in the liquid diet group during hospitalization. The other endpoints were equivalent between the groups. CONCLUSION: Early initiation of solid foods after ESD is feasible and associated with higher QOL, potentially rendering conventional liquid diets unnecessary, although additional studies are needed (Trial registration number: UMIN000013297).

Safety and efficacy of metallic stent for unresectable distal malignant biliary obstruction in elderly patients.

AIM: To study the safety of insertion of metallic stents in elderly patients with unresectable distal malignant biliary obstruction. METHODS: Of 272 patients with unresectable distal malignant biliary obstruction, 184 patients under the age of 80 were classified into Group A, and 88 subjects aged 80 years or more were classified into Group B. The safety of metallic stent insertion, metal stent patency period, and the obstruction rate were examined in each group. RESULTS: In Group B, patients had a significantly worse performance status, high blood pressure, heart disease, cerebrovascular disease, and dementia; besides the rate of patients orally administered antiplatelet drugs or anticoagulants tended to be higher (P < 0.05). Metallic stents were successfully inserted in all patients. The median patency period was 265.000 ± 26.779 (1-965) d; 252.000 ± 35.998 (1-618) d in Group A and 269.000 ± 47.885 (1-965) d in Group B, with no significant difference between the two groups. Metallic stent obstruction occurred in 82 of the 272 (30.15%) patients; in 53/184 (28.80%) patients in Group A and in 29/88 (32.95%) of those in Group B, showing no significant difference between the two groups. Procedural accidents due to metal stent insertion occurred in 24/272 (8.8%) patients; in 17/184 (9.2%) of patients in Group A and in 7/88 (8.0%) of those in Group B, with no significant difference between the two groups, either. CONCLUSION: These results suggested that metallic stents can be safely inserted to treat unresectable distal malignant biliary obstruction even in elderly patients aged 80 years or more.

Multicenter study of endoscopic preoperative biliary drainage for malignant hilar biliary obstruction: E-POD hilar study.

BACKGROUND AND AIM: Endoscopic nasobiliary drainage (ENBD) is often recommended in preoperative biliary drainage (PBD) for hilar malignant biliary obstruction (MBO), but endoscopic biliary stent (EBS) is also used in the clinical practice. We conducted this large-scale multicenter study to compare ENBD and EBS in this setting. METHODS: A total of 374 cases undergoing PBD including 281 ENBD and 76 EBS for hilar MBO in 29 centers were retrospectively studied. RESULTS: Extrahepatic cholangiocarcinoma (ECC) accounted for 69.8% and Bismuth-Corlette classification was III or more in 58.8% of the study population. Endoscopic PBD was technically successful in 94.6%, and adverse event rate was 21.9%. The rate of post-endoscopic retrograde cholangiopancreatography pancreatitis was 16.0%, and non-endoscopic sphincterotomy was the only risk factor (odds ratio [OR] 2.51). Preoperative re-intervention was performed in 61.5%: planned re-interventions in 48.4% and unplanned re-interventions in 31.0%. Percutaneous transhepatic biliary drainage was placed in 6.4% at the time of surgery. The risk factors for unplanned procedures were ECC (OR 2.64) and total bilirubin ≥ 10 mg/dL (OR 2.18). In surgically resected cases, prognostic factors were ECC (hazard ratio [HR] 0.57), predraiange magnetic resonance cholangiopancreatography (HR 1.62) and unplanned re-interventions (HR 1.81). EBS was not associated with increased adverse events, unplanned re-interventions, or a poor prognosis. CONCLUSIONS: Our retrospective analysis did not demonstrate the advantage of ENBD over EBS as the initial PBD for resectable hilar MBO. Although the technical success rate of endoscopic PBD was high, its re-intervention rate was not negligible, and unplanned re-intervention was associated with a poor prognosis in resected hilar MBO.

Advances in the genome-wide association study of chronic hepatitis B susceptibility in Asian population.

Chronic hepatitis B (CHB) is the most common chronic liver disease resulting from viral infection and has become a serious threat to human health. Each year, about 1.2 million people in the world die from diseases caused by chronic infection of hepatitis B virus. The genetic polymorphism is significantly associated with the susceptibility to chronic hepatitis B. Genome-wide association study was recently developed and has become an important tool to detect susceptibility genes of CHB. To date, a number of CHB-associated susceptibility loci and regions have been identified by scientists over the world. To clearly understand the role of susceptibility loci in the occurrence of CHB is important for the early diagnosis and prevention of CHB.

Curative resectability of gastrointestinal cancer identified from iron deficiency anemia.

The present study aimed to clarify the staging and curative resectability of gastrointestinal cancer found through iron deficiency anemia (IDA). An electronic database was used and females >51 and males >18 years old were identified who had been diagnosed with IDA at the internal medicine outpatient clinic of Asahi General Hospital (Chiba, Japan) from 1 April 2010 to 31 March 2012. IDA was defined as a hemoglobin level of <135 g/l for males and <120 g/l for females, combined with a serum ferritin level of <33.71 pmol/l. Of the 472 patients who had been diagnosed with IDA, 347 patients underwent either a gastroscopy and/or colonoscopy, including 120 patients who had undergone both gastroscopy and colonoscopy, 197 patients who only underwent gastroscopy, and 30 patients who only underwent colonoscopy. In total, 125/472 patients diagnosed with IDA did not undergo a gastroscopy or a colonoscopy. From the 50 patients who were diagnosed with cancer as a result of the investigation, 24 patients had gastric cancer and 23 patients had colorectal cancer. Of the gastric cancer patients, 6 patients were stage I, 3 patients stage II, 5 patients were stage III and 9 patients were stage IV. In colorectal cancer, 9 patients were stage II, 8 patients were stage III and 4 patients were stage IV. Curative surgery including endoscopic treatment was performed on 14 gastric cancer patients and 17 colorectal cancer patients of stage III or lower. Malignancies were found in 50 patients with IDA, and curative surgery was performed on >50% of the patients.

Clinical utility of 0.025-inch guidewire VisiGlide2TM in the endoscopic retrograde cholangiopancreatography-related procedures.

AIM: To examine the result of the use of 0.025-inch guidewire (GW) VisiGlide2TM as the first choice in the endoscopic retrograde cholangiopancreatography (ERCP)-related procedures without selecting the patient in a multicenter prospective study. METHODS: ERCP using 0.025-inch GW VisiGlide2TM as the first choice was conducted in patients who have needed ERCP, and its accomplishment rate of procedure, procedural time, incidence of accidental symptoms were compared with those of ERCP using 0.025-inch GW VisiGlideTM. RESULTS: The accomplishment rate of procedure was 97.5% (197/202), and procedural time was 23.930 ± 16.207 min. The accomplishment rate of procedure using 0.025-inch GW VisiGlideTM was 92.3% (183/195), and procedural time was 31.285 ± 19.122 min, thus the accomplishment rate of procedure was significantly improved and procedural time was significantly shortened (P < 0.05). Accidental symptoms by ERCP-related procedures were observed in 3.0% (6/202), and all were conservatively alleviated. CONCLUSION: When 0.025-inch GW VisiGlide2TM was used for ERCP-related procedure as the first choice, it showed high accomplishment rate of procedure and low incidence of accidental symptoms, suggesting it can be used as the universal GW. Clinical Trial Registry (UMIN0000016042).

Multicenter study of endoscopic preoperative biliary drainage for malignant distal biliary obstruction.

AIM: To determine the optimal method of endoscopic preoperative biliary drainage for malignant distal biliary obstruction. METHODS: Multicenter retrospective study was conducted in patients who underwent plastic stent (PS) or nasobiliary catheter (NBC) placement for resectable malignant distal biliary obstruction followed by surgery between January 2010 and March 2012. Procedure-related adverse events, stent/catheter dysfunction (occlusion or migration of PS/NBC, development of cholangitis, or other conditions that required repeat endoscopic biliary intervention), and jaundice resolution (bilirubin level < 3.0 mg/dL) were evaluated. Cumulative incidence of jaundice resolution and dysfunction of PS/NBC were estimated using competing risk analysis. Patient characteristics and preoperative biliary drainage were also evaluated for association with the time to jaundice resolution and PS/NBC dysfunction using competing risk regression analysis. RESULTS: In total, 419 patients were included in the study (PS, 253 and NBC, 166). Primary cancers included pancreatic cancer in 194 patients (46%), bile duct cancer in 172 (41%), gallbladder cancer in three (1%), and ampullary cancer in 50 (12%). The median serum total bilirubin was 7.8 mg/dL and 324 patients (77%) had ≥ 3.0 mg/dL. During the median time to surgery of 29 d [interquartile range (IQR), 30-39 d]. PS/NBC dysfunction rate was 35% for PS and 18% for NBC [Subdistribution hazard ratio (SHR) = 4.76; 95%CI: 2.44-10.0, P < 0.001]; the pig-tailed tip was a risk factor for PS dysfunction. Jaundice resolution was achieved in 85% of patients and did not depend on the drainage method (PS or NBC). CONCLUSION: PS has insufficient patency for preoperative biliary drainage. Given the drawbacks of external drainage via NBC, an alternative method of internal drainage should be explored.

[A case of gastric carcinosarcoma treated with surgical resection and irinotecan and mitomycin C combination therapy].

A 59-year-old man was admitted following episodes of melena. Upper gastrointestinal endoscopy revealed a type 2 carcinoid-like tumor in the cardium of the stomach. Histopathological analysis of a biopsy specimen revealed adenocarcinoma. Although hepatic metastases were detected, total gastrectomy was initially performed for hemorrhage control. The final histopathological diagnosis of the resected primary tumor was gastric carcinosarcoma with an osteosarcoma component. After ineffective first-line combination therapy with S-1 (tegafur, gimeracil, and oteracil) and cisplatin, irinotecan and mitomycin C chemotherapy was introduced. Although the hepatic metastases showed shrinkage after three courses of the chemotherapy, the patient succumbed seven months after surgery. This case report suggests that systemic chemotherapy using irinotecan and mitomycin C may be effective in the treatment of gastric carcinosarcoma with an osteosarcoma component and distant metastases.

Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer.

PURPOSE: The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-1 (GS) combination chemotherapy in patients with unresectable pancreatic cancer. METHODS: Patients were randomly assigned to receive GS (oral S-1 60 mg/m(2) daily on days 1-15 every 3 weeks and gemcitabine 1,000 mg/m(2) on days 8 and 15) or gemcitabine (1,000 mg/m(2) on days 1, 8, and 15 every 4 weeks). The primary endpoint was progression-free survival (PFS). RESULTS: One hundred and one patients were randomly assigned. PFS was significantly longer in the GS arm with an estimated hazard ratio (HR) of 0.65 (95 % CI 0.43-0.98; P = 0.039; median 5.3 vs 3.8 months). Objective response rate (ORR) was also better in the GS arm (21.6 vs 6 %, P = 0.048). Median survival was 8.6 months for GS and 8.6 months for GEM (HR 0.93; 95 % CI 0.61-1.41; P = 0.714). Grade 3-4 neutropenia (44 vs 19.6 %, P = 0.011) and thrombocytopenia (26 vs 8.7 %, P = 0.051) were more frequent in the GS arm. CONCLUSIONS: GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.

Long-term outcome of the WallFlex partially covered stent for unresectable malignant biliary obstruction: a multicenter single-arm prospective study.

BACKGROUND/AIMS: Covered metallic stent was developed to prevent tumor ingrowth. However, procedural accidents due to its insertion often occur and migration after long-term insertion causes problems. The WallFlex partially covered stent (WF) with reduced axial force enables stenting along the bile duct. We examined the usefulness of WF placement in an unresectable malignant distal biliary obstruction. METHODOLOGY: We examined procedural accidents, stent obstruction rate, and patency period caused by WF insertion. RESULTS: Ninety-seven patients were analyzed; procedural accidents caused by WF insertion occurred in 8 patients (7.2%) composed of acute cholecystitis in 3 patients (3.2%), acute pancreatitis in 2 patients (2.1%), acute cholangitis in 1 patient (1%), and other in 1 patient (1%). The stent obstruction rate was 19.6% (19 patients), and obstruction cause includes sludge in 9 patients (9.3%), migration in 4 patients (4.1%), food impaction in 3 patients (3.1%), ingrowth in 1 patient (1%), overgrowth in 0 patients (0%), and unknown in 2 patients (2.1%). The mean stent patency period was 634.918 +/- 66.545 (7-946) days. CONCLUSIONS: WF has less procedural accidents when inserted into unresectable malignant biliary obstruction patients with reduced migration rate after a long period and low obstruction rate.