Efficacy of vonoprazan 10 mg compared with 20 mg for the initial treatment in patients with erosive esophagitis: a randomized pilot study.

BACKGROUND: The study aimed to investigate the efficacy of vonoprazan 10 mg compared with 20 mg in patients with erosive esophagitis. METHOD: Seventy-three patients with erosive esophagitis were randomly divided into two groups either vonoprazan 20 mg (n = 37) or 10 mg (n = 36). They were administered each dose for 4 weeks as the initial treatment followed by maintenance treatment with 10 mg for 8 weeks. The primary endpoints were mucosal healing rate and symptom relief at 4 weeks. The secondary endpoint was symptom relief at 12 weeks after the maintenance treatment. Mucosal healing was assessed endoscopically, and symptom relief was assessed using the FSSG score. RESULTS: At 4 weeks, the endoscopic healing rates of the 20 mg and 10 mg groups were 94.6% and 94.4%, respectively. The FSSG scores of the 20 mg and 10 mg groups were significantly decreased in both treatment groups from 13 (4-39) to 4 (0-25) and 14 (4-40) to 3 (0-29), respectively. At 12 weeks, the scores further decreased to 2 (0-13) and 2 (0-26), respectively. The vonoprazan 10 mg group showed a similar therapeutic effect to the 20 mg group in mucosal healing at 4 weeks and in symptom relief throughout the study period. When stratified by esophagitis grading, these findings were still demonstrated in grade A/B patients but not in grade C/D patients. CONCLUSION: Our findings suggest that initial treatment with vonoprazan 10 mg might be useful especially in patients with mild erosive esophagitis. Large controlled studies are warranted to confirm our investigation.

Watch-and-wait policy versus rituximab-combined chemotherapy in Japanese patients with intestinal follicular lymphoma.

BACKGROUND AND AIM: Few reports have demonstrated the effectiveness of treatments for intestinal follicular lymphoma (FL) because of the limited number of patients who undergo comprehensive small intestinal examinations. This study compared the efficacy of rituximab-combined chemotherapy in patients with asymptomatic and low tumor burden (LTB) intestinal FL, according to the criteria of the Groupe d'Etude des Lymphomes Folliculaires, with that of a "watch and wait" (W&W) approach. METHODS: The endoscopic examination for entire gastrointestinal tracts was performed in 29 Japanese patients with intestinal FL. These patients had CD21-positive follicular dendritic cells arranged in a duodenal pattern. In a prospective, two-center, open-label trial, this study evaluated the efficacy of rituximab-combined chemotherapy ([cyclophosphamide, doxorubicin, vincristine, and prednisone] or [cyclophosphamide, vincristine, and prednisone]) and prolonged treatment with rituximab (R-Chemo+prolongedR) in 14 patients and compared their outcomes with those of 15 patients managed with a W&W approach. RESULTS: Four patients managed with the W&W plan showed worsening macroscopic findings, lesion area enlargement, or clinical stage progression but stayed on this plan because they had LTB and experienced no changes in bowel function. In the R-Chemo+prolongedR group, all patients achieved complete remission; recurrence occurred in one patient, who was subsequently managed with the W&W plan because of LTB. There were no significant differences in progression-free survival between the two groups (P = 0.1045). Overall survival was 100% in both groups. CONCLUSIONS: The prognoses of patients with asymptomatic intestinal FL and LTB who were managed with a W&W strategy were comparable with those of patients receiving R-Chemo+prolongedR.

Evaluation and validation of computed virtual chromoendoscopy in early gastric cancer.

BACKGROUND: The Flexible spectral Imaging Color Enhancement (FICE) system estimates the spectrum reflectance from a white-light endoscopic image and reconstitutes a color image from the wavelength, including useful information about the GI tract. The aim of this study was to investigate the usefulness of FICE with a specific wavelength in the assessment of early gastric cancers (EGCs), and the relationship between the FICE visualization and blood vessels. DESIGN: A retrospective study. SETTING: Department of Endoscopy, Hiroshima University, Hiroshima, Japan. PATIENTS AND MAIN OUTCOME MEASUREMENTS: The study subjects consisted of 100 patients with EGCs (78 differentiated, 22 undifferentiated) who underwent an endoscopic or surgical resection. We analyzed the wavelengths to generate the maximum difference of the spectral reflectance between the normal gastric mucosa and the EGCs. We observed the same visual field first with white-light endoscopy and then with the FICE system. Then, we scored the demarcation of color between the cancer and the normal mucosa of white-light endoscopic observation and FICE observation, each without magnification. We examined the relationship between the score of the FICE image and the section of the vascular space. RESULTS: The wavelength that generated the maximum difference in the tissue was 530 nm. The score of the FICE observation improved in 46 cases (46%), was unchanged in 54 cases (54%), and decreased in no cases (0%). There was a correlation between the score of the FICE images and the section of the vascular spaces. CONCLUSIONS: The FICE observation demonstrated that setting the wavelength at 530 nm resulted in an improvement in the visualization of the EGCs. It is thought that the FICE system is noninvasive and may more easily detect EGC without dye during both routine and detailed examinations.

Usefulness of endoscopic ultrasonography in determining the depth of invasion and indication for endoscopic treatment of early gastric cancer.

INTRODUCTION: Endoscopic ultrasonography (EUS) is a useful method for visualizing features of gastric cancer. However, a previously reported classification system tended to result in overstaging. We investigated the usefulness of EUS for evaluation of the depth of gastric cancer invasion and indications for endoscopic treatment. METHODS: Accuracy of EUS for determining the depth of invasion and incidences of a positive basal margin were assessed in 235 patients who underwent endoscopic treatment or surgery for gastric cancer. The EUS-determined depth of invasion was classified as follows: EUS-M (lesion confined to sonographic layers 1 and 2); EUS-M/SM border (lesion with changes in sonographic layer 3 but no deeper than 1 mm); EUS-SM (lesion with changes in sonographic layer 3 deeper than 1 mm); or EUS-AD (lesion with changes in sonographic layer 4 or 5). RESULTS: Accuracy of EUS for determining the depth of invasion was as follows: EUS-M, 99% were M and SM1 lesions; EUS-M/SM border, 87% were M and SM1 lesions; EUS-SM, 91% were SM2 lesions; EUS-AD, 100% were muscularis propria or deeper lesions. There was no EUS-M or EUS-M/SM border lesion for which endoscopic treatment resulted in a positive basal margin. CONCLUSIONS: EUS is useful for accurately determining the depth of invasion of gastric cancer. When there are no endoscopically determined ulcerous changes, endoscopic treatment should be considered for EUS-M and EUS-M/SM border lesions, and EUS-SM lesions should be treated surgically.

Endoscopic submucosal dissection for colorectal neoplasia: possibility of standardization.

BACKGROUND: Endoscopic submucosal dissection (ESD) has been positively applied to and gradually standardized for early stomach cancer, particularly in Japan. However, because it is technically difficult to perform ESD of the colon, ESD is not a commonly used technique. OBJECTIVE: The aim of this study was to evaluate the possibility of standardizing colorectal ESD. SETTING: ESD was performed at the Department of Endoscopy, Hiroshima University Hospital. DESIGN: Time required for ESD, rate of complete en bloc resection, complication, and postoperative local persistence and recurrence were investigated retrospectively in 70 cases of colorectal neoplasia, wherein the lesion was more than 20 mm in diameter. INTERVENTIONS: All lesions were resected by ESD. RESULTS: The average (+/-SD) time required for ESD was 70.5+/-45.9 minutes (range, 15-180 minutes), and the histologic rate of complete en bloc resection was 80.0% (56/70). With regard to complication, 1.4% of cases of postoperative hemorrhage (1/70) and 10.0% of cases of perforation (7/70) were observed in total. The rate of perforation was investigated with respect to the type of knife used for ESD and the period after the induction of ESD. The rate of perforation markedly decreased with the practice of the technique. Moreover, the rate of perforation was high when an insulated-tip diathermic knife was used; practicing this technique was insufficient to reduce the rate of perforation. The average duration of follow-up was 614+/-289.5 days, and no case of local persistence and recurrence or metastasis was observed. LIMITATIONS: The ESD technique depends on the level of each skill of each colonoscopist. CONCLUSIONS: With regard to ESD of the colon, complication, eg, perforation, could be decreased by sufficient practice and selection of an appropriate knife. It is suggested that, in the near future, ESD will be standardized for the colon.

Optical biopsy of GI lesions by reflectance-type laser-scanning confocal microscopy.

BACKGROUND: Laser-scanning confocal microscopy (LCM) is a new, noninvasive method of optical imaging that may be able to provide an instant microscopic image of untreated tissue under endoscopy. OBJECTIVE: The aim of this study was to compare LCM images and histologic images of GI lesions to clarify the usefulness of LCM in diagnosing neoplastic lesions. DESIGN: This study was a feasibility study. SETTING: The Department of Endoscopy, Hiroshima University Hospital. PATIENTS AND MAIN OUTCOME MEASUREMENTS: The study materials were GI lesions resected endoscopically at our institute. Twenty-two areas of 15 untreated specimens from the esophagus (normal mucosa, n=1; dysplasia, n=1), stomach (normal mucosa, n=3; cancer, n=5), and colon (normal mucosa, n=3; adenoma, n=8; cancer, n=1) were examined. LCM images and images of hematoxylin and eosin-stained sections were compared. A prototype probe LCM system that is equipped with a semiconductor laser that oscillates at 685 nm and that analyzes reflected light was used. RESULTS: Smooth nuclei of cells were visualized by LCM in the normal esophageal-mucosa specimen. Irregular nuclei were visualized in 3 of 5 gastric-cancer specimens and in cells around the crypt of the colonic-cancer specimen. Nuclei were visualized in 5 of 8 colonic-adenoma specimens. Nuclei were not visualized in 2 of 3 normal gastric-mucosa specimens or in normal colonic-mucosa specimens. CONCLUSIONS: LCM provides instant microscopic images, and, with further technical improvement, in the future this novel method will aid in immediate diagnosis under endoscopy without the need for tissue biopsy.

Advantage of endoscopic submucosal dissection compared with EMR for early gastric cancer.

BACKGROUND: In EMR of early gastric cancer (EGC), en bloc resection reduces the risk of residual cancer. Endoscopic submucosal dissection (ESD) now allows en bloc resection of large EGCs. OBJECTIVE: To retrospectively determine whether ESD is more advantageous than EMR for EGCs. DESIGN: EMR (825 lesions, 711 patients) or ESD (195 lesions, 185 patients) was performed. The en bloc resection rate, histologically complete resection rate, operation time, complications, and local recurrence rate were studied in relation to ulceration. SETTING: Hiroshima University Hospital. PATIENTS: Subjects comprised 896 patients in whom 1020 EGCs were resected endoscopically from 1990 to 2004. RESULTS: In cases without ulceration, en bloc and histologically complete resection rates were significantly higher with ESD than with EMR, regardless of tumor size. The frequency of ulceration did not differ significantly between groups. Average operation time was significantly longer for ESD than for EMR, regardless of tumor size. Also, regardless of ulceration, the incidence of intraoperative bleeding was significantly higher with ESD (22.6%) than with EMR (7.6%). Delayed bleeding did not differ. In cases with ulceration, the incidence of perforation was significantly higher with ESD (53.8%) than with EMR (2.9%). Local recurrences were treated by incomplete EMR (en bloc, 2.9%; piecemeal, 4.4%). No patient experienced recurrence after ESD. CONCLUSIONS: ESD increased en bloc and histologically complete resection rates and may reduce the local recurrence rate. Increased operation time and complication risks with ESD in comparison with EMR remain problematic. Special measures are necessary for ESD of ulcerated lesions to reduce the rates of perforation and incomplete resection.