Interobserver variability in endoscopic ultrasonography: a prospective evaluation.

BACKGROUND: Endoscopic ultrasonography (EUS) is an imaging modality that is now widely used to stage gastrointestinal malignancies. Few studies have addressed the issue of interobserver variability in the interpretation of EUS, particularly as it pertains to the staging of rectal carcinoma. METHODS: Twenty-six patients with a diagnosis of rectal carcinoma were evaluated prospectively by three endoscopists. One performed sigmoidoscopy, the second (primary endosonographer) performed an EUS staging examination with full knowledge of the patient history and sigmoidoscopic appearance of the lesion, and the third endoscopist (secondary endosonographer) performed EUS blinded to this information. The results of the respective examinations were then compared. RESULTS: When the EUS findings of the endosonographers were compared, T stage agreed in 88% of patients, with the following kappa coefficients: T1 (kappa = 0.00); T2 (kappa = -0.04); T3 (kappa = -0.05); T4 (kappa = 0.00). Interrator N stage agreed in 73% of patients (kappa = 0.42). CONCLUSION: Our study prospectively evaluated interobserver variation in staging rectal carcinoma by EUS. The protocol that was followed provides a useful template that eliminated potential observer bias. Fair agreement was demonstrated regarding lymph node assessment. Although the raters agreed in 88% of the patients, kappa statistic analysis did not reach significant agreement, due to this institution's preponderence of UT3 lesions. Thus, validation of our findings in a setting where a broader spectrum of disease is encountered is required.

Clinical implications of endoscopic ultrasound: the American Endosonography Club Study.

BACKGROUND: Despite increased clinical use of endoscopic ultrasound (EUS), there are little data regarding complications of EUS or its impact on patient management. METHODS: A prospective multicenter study was completed to evaluate clinical outcomes of EUS. Before each EUS examination the endosonographer recorded further theoretical patient management plans as if EUS was unavailable. After the EUS, endosonographers recorded actual management plans based on EUS results. The actual management plan after EUS was compared to the theoretical management before EUS. Complications were assessed in short-term follow-up. RESULTS: Four hundred twenty-eight subjects were enrolled. Of subjects able to be evaluated, EUS changed the treatment plan in 74%. Management changes of major importance occurred in 120 patients (31% of subjects able to be evaluated) and included decisions regarding surgery (62 patients), decisions regarding nonsurgical invasive management (36 patients), and decisions regarding further follow-up (22 patients). When there was a change in management, the change was to less costly, risky, or invasive management in 55%, to more costly/risky/invasive in 37%, and to equally costly/risky/invasive in 8%. Short-term follow-up was completed in 81% of subjects, with six complications identified (1.7%). Three complications were mild, two were moderate, one severe, and none fatal. CONCLUSIONS: (1) Changes in management plan may occur in the majority of patients based on EUS results. (2) The management changes are often of major importance with regard to health care costs and safety, and are more often in the direction of less costly, risky, and invasive management. (3) EUS is safe in experienced hands.

Endoscopic stenting for pain relief in chronic pancreatitis: results of a standardized protocol.

BACKGROUND: Pancreatic endoscopic stenting aims to relieve abdominal pain due to chronic pancreatitis. Optimal treatment modalities and post-treatment effects have still to be determined. The object of this study was to investigate the results of a standardized protocol of endoscopic stenting. METHODS: Twenty-three patients with abdominal pain due to chronic pancreatitis and stricture of the distal main pancreatic duct were treated according to the following protocol: after balloon dilation of the stenosis, a 10F stent was placed into the main pancreatic duct and then exchanged every 2 months, the total duration of drainage being 6 months. RESULTS: Use of analgesics could be discontinued in 17 patients (74%) on termination of drainage, and in 12 patients (52%) 1 year later. These results were significantly associated with reduction of main pancreatic duct diameter and resolution of stricture, but were not influenced by abstinence from alcohol and pancreatic enzyme supplementation. CONCLUSIONS: Pancreatic duct stenting results in short-term clinical improvement in patients with chronic pancreatitis and proximal main pancreatic duct stricture. Persistence of advantageous clinical results is to be expected in 50% of cases and when strictures have resolved.

Cellular kinetics in rectal cancer.

Measurements of dynamic tumour cell kinetic parameters, particularly the potential doubling time (Tpot) may have potential as predictive assays for treatment outcome after radiotherapy. This paper details the distributions of Tpot and other kinetic and DNA content parameters measured in rectal cancers. Biopsies were taken from 119 patients approximately 6 h after infusion of 200 mg m-2 bromodeoxyuridine (BrdUrd). The samples were analysed by bivariate DNA/BrdUrd flow cytometry. The primary purpose of the study was to measure the kinetic parameters of labelling index (LI), duration of S-phase (TS) and Tpot. Secondarily, tumour DNA ploidy (DNA index) and S-phase fractions (SPFs) were also estimated from the univariate DNA histograms. The 101 evaluable patients were classified according to clinical stage as T2 (n = 12), T3 (n = 53), T4 (n = 28) or recurrent tumours (n = 8). Of the evaluable tumours, 73 were DNA aneuploid. The median LI, TS, and Tpot of the aneuploid tumours were 21%, 20 h and 3.3 days respectively. The calculated LI, TS, and Tpot of diploid tumours were subject to uncertainties because of the contribution of normal cells. The LI and SPF of all tumours were, however, significantly (P < 0.001) correlated, having a correlation coefficient of only 0.76. The wide distributions of values for LI (quartiles 13.5%, 26.9%) and Tpot (quartiles 2.4, 5.6 days) that were found are necessary baseline information if these parameters are to be useful in individual treatment selection or as predictors of treatment outcome.

Preoperative infusional chemoradiation therapy for stage T3 rectal cancer.

PURPOSE: To evaluate preoperative infusional chemoradiation for patients with operable rectal cancer. METHODS AND MATERIALS: Preoperative chemoradiation therapy using infusional 5-fluorouracil (5-FU), (300 mg/m2/day) together with daily irradiation (45 Gy/25 fractions/5 weeks) was administered to 77 patients with clinically Stage T3 rectal cancer. Endoscopic ultrasound confirmed the digital rectal exam in 63 patients. Surgery was performed approximately 6 weeks after the completion of chemoradiation therapy and included 25 abdominoperineal resections and 52 anal-sphincter-preserving procedures. RESULTS: Posttreatment tumor stages were T1-2, N0 in 35%, T3 N0 in 25%, and T1-3, N1 in 11%; 29% had no evidence of tumor. Local tumor control after chemoradiation was seen in 96% (74 out of 77); 2 patients had recurrent disease at the anastomosis site and were treated successfully with abdominoperineal resection. Overall, pelvic control was obtained in 99% (76 out of 77). The survival after chemoradiation was higher in patients without node involvement than in those having node involvement (p = n.s.). More patients with pathologic complete responses or only microscopic foci survived than did patients who had gross residual tumor (p = 0.07). The actuarial survival rate was 83% at 3 years; the median follow-up was 27 months, with a range of 3 to 68 months. Acute, perioperative, and late complications were not more numerous or more severe with chemoradiation therapy than with traditional radiation therapy (XRT) alone. CONCLUSIONS: Excellent treatment response allowed two-thirds of the patients to have an anal-sphincter-sparing procedure. Gross residual disease in the resected specimen indicates a poor prognosis, and therapies specifically targeting these patients may improve survival further.

Feasibility of five courses of pre-operative chemotherapy in patients with resectable adenocarcinoma of the oesophagus or gastrooesophageal junction.

The purpose of this study was to examine the feasibility of administering all chemotherapy pre-operatively to patients with resectable adenocarcinoma of the oesophagus or gastrooesophageal junction. 32 patients with potentially resectable adenocarcinoma of the oesophagus or gastrooesophageal junction were studied in a stepwise fashion in which combination chemotherapy with cisplatin, high-dose arabinoside and 5-fluorouracil was administered. In the first part, 15 patients were to receive three chemotherapy courses pre-operatively and two chemotherapy courses postoperatively. In the second part, the next 15 patients were to receive all five chemotherapy courses pre-operatively, provided there was an objective response after three courses. Endoscopic ultrasonography was also performed, when feasible, prior to chemotherapy and surgery, and in some patients sequentially between chemotherapy courses. All of the 14 assessable patients in the first group tolerated all three courses of pre-operative chemotherapy, and 86% of patients in this group completed all protocol chemotherapy. In the second group, 9 of 18 (50%) assessable patients tolerated all five courses of preoperative chemotherapy, and 100% of patients in this group received all protocol chemotherapy. The median number of chemotherapy courses for the entire group (32 patients) was five (range one to five). Forty-one per cent (13/32) of patients had a major response to chemotherapy. Sixty-nine per cent (or 76% of 29 patients taken to surgery) had a curative resection. One patient had a pathological complete response. The median survival time of 32 patients was 17 months (range 2-36+ months). 14 patients (37%) remain alive at a median follow-up time of 26+ months. There was a correlation between endoscopic ultrasonographic tumour and nodal stage and pathological tumour and nodal stages in 16 patients. The tumour stage correlation was higher (75%) than the nodal stage correlation (62%). Our data suggest that it is feasible to administer five courses of cisplatin-based chemotherapy to patients with potentially resectable adenocarcinoma of the oesophagus or gastrooesophageal junction. More effective chemotherapy regimens that might result in higher pathological complete response rates and acceptable toxic effects are needed.

Endoscopic ultrasonography in the quantitative assessment of response to chemotherapy in patients with adenocarcinoma of the esophagus and esophagogastric junction.

We used endoscopic ultrasonography (EUS) to clinically stage eight patients with adenocarcinoma of the esophagus and to monitor their disease after subsequent courses of experimental preoperative chemotherapy. Stage of disease (TNM), tumor area, and tumor width were determined at each session. These results were then compared with barium esophagram and histopathology from resection specimens. EUS provided a consistent interpretation of the stage of disease and accurately predicted histopathologic findings. Measurement of tumor area and maximal width did not reliably correlate with the response to chemotherapy as assessed by barium esophagram. Although this technique seems promising, it cannot yet be recommended as a means of predicting response to chemotherapy.

Endoscopic ultrasonography in staging rectal cancer.

Endoscopic ultrasonography (EUS) was used to stage rectal cancer by assessing depth of invasion through bowel wall layers and/or involvement of lymph nodes. EUS findings were correlated with histopathologic findings to discern the usefulness of this modality in predicting which patients could be candidates for sphinctersaving procedures and the avoidance of abdominoperineal resection. The Olympus EU-M3 endoscopic ultrasound system was used to assess depth of penetration through rectal wall layers and to identify lymph nodes. Comparison of EUS findings to histopathologic findings was possible in 13 patients. EUS agreed with histopathology in 9 of 13 cases (69.3%) ( p = 0.07, kappa statistic). EUS agreed with histopathology as the presence or absence of lymph nodes in 9 of 13 cases (69.3%) (p = 0.07). However, the presence of lymph nodes could not necessarily predict metastatic involvement of these nodes. In one patient, invasion of vaginal cuff was correctly predicted. In nine cases, computed tomographic analysis (CT) was available for comparison to EUS in detection of penetration beyond the bowel wall. CT agreed with histopathology in 3 of 9 (33%), whereas EUS agreed with histopathology in 7 of 9 (78%).