Background and Aims Image quality can be guaranteed with the conventional dosage of fluorescein sodium in probe-based confocal laser endomicroscopy (pCLE). However, yellow discoloration of the skin ...seriously affects daily life and simultaneously increases the risk of adverse events such as allergic reactions. The aim of this study was to test whether a lower dosage of fluorescein sodium can provide satisfactory image quality and to compare the diagnostic accuracy of gastric intestinal metaplasia (GIM) through a randomized blind controlled trial. Methods Consecutive patients were randomly assigned to different doses of fluorescein sodium. Image quality was determined by the endoscopists’ subjective assessments and signal-to-noise ratio (SNR) assessment systems. Skin discoloration was tested using a neonatal transcutaneous jaundice detector. In addition, consecutive patients with a known or suspected diagnosis of GIM were examined by pCLE with the lower dose and the traditional dose. Results Only 0.01 mL/kg dose of 10% fluorescein sodium led to a significant decrease in image quality ( P < .05), and a dose of 0.02 mL/kg had the highest SNR value ( P < .05). There were no significant differences in skin discoloration between the 0.01 mL/kg and 0.02 mL/kg doses ( P = .148) and no statistical difference in the diagnostic accuracy of pCLE for GIM between the 0.02 mL/kg and 0.10 mL/kg doses ( P > .05). The kappa values for the correlation between pCLE and histopathology were 0.867 (95% confidence interval, 0.782–0.952) and 0.891 (95% confidence interval, 0.811–0.971). Conclusions The 0.02 mL/kg dose of 10% fluorescein sodium seems to be the best dose for pCLE in the upper GI tract, with comparable image quality with the conventional dose and insignificant skin discoloration. This dose is also very efficient for the diagnosis of GIM.
To evaluate the safety and efficacy of a new crosslinked hyaluronan (NCH) gel in reducing postoperative adhesions.
Randomized controlled trial (Canadian Task Force classification I).
Seven ...departments of obstetrics and gynecology in China.
A total of 216 women scheduled for gynecologic laparoscopic surgery for primary removal of adhesions, myomas, ovarian cysts, or endometriotic cysts.
Patients were randomized to receive either NCH gel or saline with 1:1 allocation.
All patients were evaluated using a modified American Fertility Society (mAFS) scoring system for the incidence, extent, and severity of pre-existing and postoperative adhesions at the 10 anatomic sites of ovaries/tubes and at the expanded 23 or 24 anatomic sites throughout the abdominopelvic cavity by laparoscopy. A total of 215 randomized patients were treated with either saline solution (108 of 108) or NCH gel (107 of 108), composing the full analysis set (FAS), and 196 patients (94 of 108 in the saline control group and 102 of 108 in the NCH gel group) completed the entire study, composing the per protocol set (PPS). The postoperative incidence of moderate or severe adhesions evaluated at the 10 sites (the primary endpoint for efficacy) was 27.7% in the control group and 9.8% in the NCH gel group, a difference of 14.4% (95% confidence interval CI, 2.6%-20.6%) in the PPS, and 37.0% in the control group and 14.0% in the NCH gel group, a difference of 20.0% (95% CI, 8.9%-26.8%) in the FAS. The postoperative incidence of moderate or severe adhesions evaluated at the 24 sites was also significantly lower in the NCH gel group compared with the control group (5.9% vs 14.9%; p = .036) in the PPS. Also in the PPS, the NCH gel group had significantly lower postoperative adhesion scores of severity, extent, and mAFS: 60.0%, 50.8%, and 76.9%, respectively (median scores of the 10 sites; p = .002) and 48.5%, 50.0%, and 72.2% (median scores of the 24 sites; p = .001) lower than those recorded in the control group. No serious adverse events were observed, and the safety profile of NCH gel was comparable to that of saline control.
This study demonstrates that NCH gel is safe and significantly reduces adnexal adhesion formation and global adhesion formation throughout the abdominopelvic cavity after gynecologic laparoscopic surgery.
To more accurately define clinical target volume for cervical cancer radiation treatment planning by evaluating tumor microscopic extension toward the uterus body (METU) in International Federation ...of Gynecology and Obstetrics stage Ib-IIa squamous cell carcinoma of the cervix (SCCC).
In this multicenter study, surgical resection specimens from 318 cases of stage Ib-IIa SCCC that underwent radical hysterectomy were included. Patients who had undergone preoperative chemotherapy, radiation, or both were excluded from this study. Microscopic extension of primary tumor toward the uterus body was measured. The association between other pathologic factors and METU was analyzed.
Microscopic extension toward the uterus body was not common, with only 12.3% of patients (39 of 318) demonstrating METU. The mean (±SD) distance of METU was 0.32 ± 1.079 mm (range, 0-10 mm). Lymphovascular space invasion was associated with METU distance and occurrence rate. A margin of 5 mm added to gross tumor would adequately cover 99.4% and 99% of the METU in the whole group and in patients with lymphovascular space invasion, respectively.
According to our analysis of 318 SCCC specimens for METU, using a 5-mm gross tumor volume to clinical target volume margin in the direction of the uterus should be adequate for International Federation of Gynecology and Obstetrics stage Ib-IIa SCCC. Considering the discrepancy between imaging and pathologic methods in determining gross tumor volume extent, we recommend a safer 10-mm margin in the uterine direction as the standard for clinical practice when using MRI for contouring tumor volume.
Background Patients diagnosed with extrahepatic bile duct carcinoma (EBDC) have a poor prognosis. Objective The purpose of these studies was to design radioactive stents for EBDC and to evaluate the ...feasibility and safety of the stents in healthy pigs. Design Plastic stents with inserted iodine-125 seeds were designed and tested in 11 healthy pigs. The pigs were divided into 4 groups on the basis of radiation doses. Interventions The stents with estimated radiation dose at a 5-mm radial distance from the axis of the seeds of 30 Gy, 60 Gy, and 90 Gy were implanted in the common bile duct (CBD) in groups A, B, and C (n = 3 in each group), with the control group (n = 2) being implanted with the stents containing nonradioactive seeds. Main Outcome Measurements Histologic evaluation was performed under a light microscope. Results The procedures were successfully performed on all pigs. Severe hyperplasia of the mucosa was seen in the control group. In the experimental groups, obvious mucosal necrosis near the radioactive seeds was observed but without perforation of the CBD wall. In lower-dose groups (30 Gy), mild hyperplasia of mucosal glands with fibrosis under the necrosis layer was seen. However, after the increase of the dose, mucosal glands were disappearing without a visible mucosal layer. Conclusions The radioactive stents are safe at each dose in healthy pigs. Moreover, our observations indicate the feasibility to design specific radioactive stents according to the size, shape, and position of EBDC in future clinical applications.
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