Prospective multicenter evaluation of colon capsule examination indicated by colonoscopy failure or anesthesia contraindication.

BACKGROUND AND STUDY AIMS: In France, in about 5% of cases colonoscopies are incomplete or temporarily contraindicated.We tested the diagnostic yield of colon capsule endoscopy (CCE) in these patients. PATIENTS AND METHODS: In a prospective study, in 17 French centers, inclusion criteria were colonoscopy failure or general disease that excluded colonoscopy with anesthesia. Patients underwent CCE using the first-generation PillCam Colon capsule. The main end point was CCE diagnostic yield, defined as identification of a colorectal lesion that directly explained symptoms or necessitated a diagnostic or therapeutic examination. A secondary objective was to test a simplified Movi-Prep colon cleansing. Follow-up to identify missed symptomatic cancer was scheduled. RESULTS: CCE showed positive findings in 36 patients (diagnostic yield 33.6 %), among whom 23 subsequently underwent therapeutic intervention. Among 64 patients with negative capsule findings, 9 had a complementary procedure showing adenomas in only 1 case. CCE was incomplete in 7/107 patients. Colonoscopy was done in one patient to retrieve a capsule retained in the left colon, and sigmoidoscopy in 11 because the rectum was not reached. No colorectal cancer was diagnosed during the follow-up period. Colon cleansing with MoviPrep was rated good or excellent in 75.9% of cases. CONCLUSION: This study shows the feasibility and the usefulness of CCE in the situation of colonoscopy failure or contraindication. The colon capsule modality should be tested against other available approaches, such as virtual colonoscopy or repeat colonoscopy by an expert.

Small-bowel capsule endoscopy diagnoses early and advanced neoplasms in asymptomatic patients with Lynch syndrome.

BACKGROUND AND STUDY AIMS: Patients with Lynch syndrome are at increased risk of developing small-bowel adenocarcinoma, which usually has a bad prognosis and needs to be diagnosed early. Our aim was to evaluate the yield of capsule endoscopy and CT enteroclysis in this situation. PATIENTS AND METHODS: We performed a prospective, blinded, comparative study of capsule endoscopy and CT enteroclysis in five academic centers. Thirty-five consecutive asymptomatic patients with Lynch syndrome, all with one proven deleterious mutation, were included. A double reading was performed blind for both types of examination. RESULTS: Histologically confirmed small-bowel neoplasms were diagnosed in three patients (8.6 %): one adenocarcinoma (T3N0M0) and two adenomas with low-grade dysplasia. Capsule endoscopy identified all neoplasms. CT enteroclysis raised suspicion of one neoplasm (adenocarcinoma) but missed the two others. Concordance between the two capsule readings was high with a κ value of 0.78 (95 %CI 0.55 to 1.0), which was not the case for CT enteroclysis, where the κ value was 0.15 (95 %CI -0.27 to 0.58). CONCLUSION: Curable early or advanced neoplasms in asymptomatic patients with Lynch syndrome using capsule endoscopy can be detected with a better reproducibility than with CT enteroclysis. The clinical usefulness of systematic small-bowel screening in these patients should be confirmed through large prospective studies.

Diagnostic accuracy of esophageal capsule endoscopy versus conventional upper digestive endoscopy for suspected esophageal squamous cell carcinoma.

BACKGROUND AND STUDY AIM: A video capsule similar to that used in small-bowel capsule endoscopy is now available for esophageal exploration. The aim of our study was to compare the accuracy of upper endoscopy (esophageal gastroduodenoscopy [EGE]) with esophageal capsule endoscopy (ECE) in patients at risk of esophageal squamous cell cancer (SCC). PATIENTS AND METHODS: 68 patients at risk of SCC secondary to a history of head and neck neoplasia were included in this comparison of techniques for detecting SCC and dysplasia. ECE was done using the first generation Pillcam ESO and EGE was performed in accordance with the usual practice of each center, followed by examination with 2 % Lugol staining and biopsy of unstained areas (39 neoplasia comprising 5 low grade dysplasia, 8 high grade dysplasia and 26 SCC). RESULTS: Compared with EGE with and without Lugol staining, the sensitivities of ECE for neoplasia diagnosis were 46 % and 54 %, respectively. On a per-patient basis, the sensitivity, specificity, and positive and negative predictive value of ECE were 63 %, 86 %, 77 % and 76 %, respectively, compared with EGE without staining, and 61 %, 86 %, 77 % and 73 % compared with EGE with iodine staining. Neither the ECE transit time nor the distance between the esopharyngeal line and the neoplastic lesion differed between the 21 false-negative and 18 true-positive cases diagnosed by ECE; the only difference was a smaller median diameter among false negatives ( P < 0.001). CONCLUSION: In a cohort at high risk for esophageal SCC, ECE is not sensitive enough to diagnose neoplastic lesions.

Esophageal capsule endoscopy vs. EGD for the evaluation of portal hypertension: a French prospective multicenter comparative study.

OBJECTIVES: Esophagogastroduodenoscopy (EGD) is the standard method for the diagnosis of esophago-gastric varices. The aim of this prospective multicenter study was to evaluate the PillCam esophageal capsule endoscopy (ECE) for this indication. METHODS: Patients presenting with cirrhotic or noncirrhotic portal hypertension underwent ECEfollowed by EGD at the time of diagnosis. Capsule recordings were blindly read by two endoscopists. RESULTS: A total of 120 patients (72 males, mean age: 58 years; mean Child-Pugh score: 7.2) were included. Esophageal varices were detected in 74 patients. No adverse event was observed after either EGD or ECE. Seven (6%) patients were unable to swallow the capsule. The mean recording time was 204 s (range 1-876). Sensitivity, specificity, negative predictive value, and positive predictive value of ECE for the detection of esophageal varices were 77%, 86%, 69%, and 90%, respectively. Sensitivity, specificity, negative and positive predictive values of ECE for the indication of primary prophylaxis (esophageal varices > or = grade 2 and/or red signs) were 77, 88, 90, and 75%, respectively, and 85% of the patients were adequately classified for the indication (or not) of prophylaxis. Interobserver concordance for ECE readings was 79.4% for the diagnosis of varices, 66.4% for the grading of varices, and 89.7% for the indication of prophylaxis. CONCLUSIONS: This large multicenter study confirms the safety and acceptable accuracy of ECE for the evaluation of esophageal varices. ECE might be proposed as an alternative to EGD for the screening of portal hypertension, especially in patients unable or unwilling to undergo EGD.

Clinical impact of capsule endoscopy compared to push enteroscopy: 1-year follow-up study.

BACKGROUND AND STUDY AIMS: The long-term outcome for patients with obscure bleeding after capsule endoscopy (CE) is still unclear. In this study, the clinical outcome was used as the gold standard to determine the sensitivity and specificity of CE and push enteroscopy (PE) in the diagnosis of small-bowel lesions in patients with obscure bleeding. PATIENTS AND METHODS: Fifty-eight patients from a previous prospective study (comparing PE and CE) were included; the patients were contacted after 1 year. The final diagnosis, bleeding status, new gastrointestinal examinations, and treatments performed were recorded. On the basis of these data, each case was classified into true/false positive or true/false negative findings at PE and CE. The results were compared with the initial classification of lesions observed at CE: highly relevant (P2) and less relevant (P0, P1) lesions. RESULTS: Follow-up data were available for 56 patients. According to the defined true/false positive and negative cases, the sensitivity and specificity values for CE and PE were 92 % and 48 %, and 80 % and 69 %, respectively ( P < 0.01 for the difference between CE and PE). Highly relevant (P2) lesions observed at CE were more frequently classified into true-positive cases (15 of 18 versus seven of 22; P < 0.01) and led more frequently to therapeutic decisions (11 of 18 versus five of 22; P = 0.02) in comparison with less relevant lesions (P0, P1). CONCLUSIONS: CE is a highly sensitive examination for the detection of small-bowel lesions in patients with obscure gastrointestinal bleeding, with a specificity lower than that of PE when the clinical outcome is used as the gold standard.

Any clinical benefit from the use of oncofoetal markers in the management of chemotherapy for patients with metastatic colorectal carcinomas?

AIMS: Computed tomography (CT) is the reference technique for evaluating response to chemotherapy. The potential helpfulness of tumour markers is debated. MATERIALS AND METHODS: From March 1997 to January 1999, 91 consecutive patients receiving chemotherapy for metastatic colorectal carcinoma underwent whole-body spiral CT, estimates of anti-carcinoembryonic antigen (CEA) and CA19-9 every 8 weeks. RESULTS: CEA and CA19-9 levels were above normal in 78 (85.7%) and 61 (67.5%) patients, respectively. Tumour response evaluation according to the RECIST criteria was obtained at 8-week evaluation in 83 (91%) patients. The positive predictive values (PPV) for response of a decrease of the marker levels were 53.8 for CEA and 41.7 for CA19-9 using a 30% decrease threshold, and 60/52.2, respectively, using a 50% decrease threshold. Meaningful PPV values (> 90%) for progression of an increase of the marker levels were only obtained using the 200% increase threshold for CEA alone or a combination of CEA and CA 19-9. A 100% CEA increase between baseline and the 8-week evaluation was correlated to overall survival (P = 0.0023). The need for a radiological confirmation of tumour progression could be avoided by the systematic dosage of tumour markers at baseline and after 8 weeks of treatment only in a sub-population of 13% of the patients with a 200% increase of CEA or CA 19-9 at 8 weeks. CONCLUSIONS: CEA, CA 19-9, or both should be used with caution for tumour response evaluation to chemotherapy in addition to CT in metastatic colorectal carcinoma.

Diagnostic value of endoscopic capsule in patients with obscure digestive bleeding: blinded comparison with video push-enteroscopy.

BACKGROUND AND STUDY AIMS: This study was designed to prospectively compare the diagnostic yield of the M2A endoscopic capsule with that of video push-enteroscopy in exploring the small intestine in patients with obscure digestive bleeding. PATIENTS AND METHODS: Patients with either occult or overt obscure digestive bleeding and a negative endoscopic work-up underwent a double intestinal investigation, with video push-enteroscopy and a wireless capsule, performed blindly by separate examiners. The diagnostic yield for each technique was defined as the frequency of detection of clinically relevant intestinal lesions, i. e. those having the potential for bleeding. RESULTS: 60 patients (27 men, 33 women; age 58 +/- 18 years; hemoglobin 9.4 +/- 2.5 g/dl) were included, 32 with occult and 28 with overt bleeding. Results were analyzed for 58 patients, who completed both examinations. Lesions were detected in 43 patients: with both techniques in 19, only by capsule in 21, and, conversely, only by push-enteroscopy in 3 ( P = 0.04). Final diagnoses were as follows: a P2 lesion with high bleeding potential in 28 patients (19 angiomata, 6 ulcerations, 2 tumors, 1 case of intestinal varices); a P1 lesion with intermediate bleeding potential in 15 patients (2 patients with mucosal erosions, 13 patients with mucosal red spots); and there were normal findings from 15 procedures. No procedure induced any complication. CONCLUSION: The use of the wireless endoscopy capsule detects significantly more clinically relevant intestinal lesions than video push-enteroscopy in patients with obscure digestive bleeding, raising the diagnostic yield to 67.2 %. Its influence on the clinical outcome for patients needs further investigation.

Assessment of tumour response to chemotherapy for metastatic colorectal cancer: accuracy of the RECIST criteria.

Evaluation of tumour size modifications in response to treatment is a critical issue in the management of advanced malignancies. In 1981, the World Health Organization (WHO) established guidelines for tumour response assessment. These WHO1981 criteria were recently simplified in a revised version, named RECIST (Response Evaluation Criteria in Solid Tumours), which uses unidimensional instead of bidimensional measurements, a reduced number of measured lesions, withdrawal of the progression criteria based on isolated increase of a single lesion, and different shrinkage threshold for definitions of tumour response and progression. In order to validate these new guidelines, we have compared results obtained with both classifications in a prospective series of 91 patients receiving chemotherapy for metastatic colorectal cancer. Data from iterative tomographic measurements were fully recorded and reviewed by an expert panel. The overall response and progression rates according to the WHO1981 criteria were 19% and 58%, respectively. Using RECIST criteria, 16 patients were reclassified in a more favourable subgroup, the overall response rate being 28% and the progression rate 45% (non-weighted kappa concordance test 0.72). When isolated increase of a single measurable lesion is not taken into account for progression with the WHO1981 criteria, only 7 patients were reclassified and the kappa test was satisfying, i.e. > or =0.75, for the whole population as well as for each of the responding and progressive subgroups. Since it provides concordant results with a simplified method, the use of RECIST criteria is recommended for evaluation of treatment efficacy in clinical trials and routine practice.

[Intussusception of the small intestine due to Peutz-Jeghers syndrome: a case report and review of the literature]. / Invagination intestinale dans le cas d'un syndrome de Peutz-Jeghers et revue de la littérature.

One case of small bowel's intussuception has been found in one patient with abdominal pains. Since 13 years this patient has a Peutz-Jeghers syndrome. A resection of the small bowel has been performed followed by total intraoperative enteroscopy. Besides small bowel, Peutz-Jeghers syndrome can affect many organs with an increased risk for cancer for patients affected by this genetic disease.

Small nodule detection in cirrhotic livers: evaluation with US, spiral CT, and MRI and correlation with pathologic examination of explanted liver.

PURPOSE: The purpose of this work was to evaluate the detection and characterization of nodules > or = 8 mm and small hepatocellular carcinomas (HCCs) in liver cirrhosis. METHOD: Pathologic examination and results of US, helical CT, and dynamic MRI with gadolinium were compared after orthotopic liver transplantation (OLT) of 43 cirrhotic patients. Nodules were classified as macroregenerative nodules (MRNs), borderline nodules (BNs), and HCC. RESULTS: Pathologic examination classified 69 nodules: 50 MRNs, 6 BNs, and 13 HCCs. Sensitivities of MRN, BN, and HCC detection were, respectively, for US imaging 2% (1/50), 33.3% (2/6), and 46.2% (6/13); for helical CT 2% (1/50), 50% (3/6), and 53.8% (7/13); and for MRI 42% (21/50), 50% (3/6), and 76.9% (10/13). MRI detected 21 MRNs. They presented on T1/T2-weighted images as hyperintense/hypointense (n = 8), hyperintense/isointense (n = 7), hypointense/hypointense (n = 4), hypointense/isointense (n = 1), and hypointense depicted only on echo planar imaging (n = 1). The three detected BNs were hyperintense/hypointense nodules. The 10 detected HCCs appeared hyperintense/isointense (n = 7), hyperintense/hypointense (n = 2), and hypointense/isointense (n = 1). None of the MRNs but eight HCCs and one BN were enhanced after gadolinium injection. CONCLUSION: Contrast-enhanced MRI is the most sensitive technique for detecting liver nodules. No MR signal intensity pattern characteristic of small HCCs enables differentiation from benign nodules, however. Gadolinium enhancement is the most sensitive and specific characteristic of HCC.

[Prospective randomized single-blind trial comparing oral sodium phosphate with polyethylene glycol for colonoscopy preparation]. / Etude prospective randomisée en simple aveugle comparant phosphate de sodium oral et polyéthylène glycol pour la préparation à la coloscopie.

AIM AND METHODS: The aim of this prospective, randomized, study performed in 60 outpatients was to compare 2 precolonoscopy bowel preparations: oral sodium phosphate (NaP) versus standard polyethylene glycol-based lavage solution (PEG). None of the patients met any of NaP exclusion criteria. All patients were prepared on the day prior to colonoscopy. A patient-questionnaire and measure of serum electrolytes (calcium, phosphate, sodium, potassium), pulse and blood pressure were used to assess tolerance and acceptability of the preparation. The quality of colon cleansing was judged by blinded endoscopists. RESULTS: Patient's tolerance to NaP was superior to PEG: NaP preparation was easier to drink and feelings of abdominal plenitude occurred in a smaller proportion of patients. A potassium decrease, a sodium increase and hyperphosphatemia were observed in the NaP group but without clinical events. PEG preparation seemed to allow a better cleansing ability compared with NaP but this difference was not statistically significant. CONCLUSIONS: NaP solution was better tolerated and accepted by patients. Colonic preparation quality compared to PEG is still to be discussed depending on the intake schedule. A biochemical data check seems necessary on account of significant serum electrolytes changes induced by NaP preparation.

[Barrett's esophagus and antireflux surgery: a study of a series of 26 patients]. / Endobrachyoesophage et chirurgie antireflux: étude d'une série de 26 patients.

STUDY AIM: The aim of this study was to report the results of a retrospective series of 26 patients with Barrett's esophagus treated by antireflux surgery. PATIENTS AND METHODS: From 1979 to 1998, 21 men and five women (mean age: 53 years) with histologically proven Barrett's esophagus underwent an antireflux procedure. The mean length of Barrett's epithelium was 5.9 cm for 19 patients (73.1%). Six patients (23.1%) had tongue lesions of Barrett's epithelium, and one (3.8%) had ectopic gastric mucosa. None of the patients had a preoperative esophageal biopsy that revealed high-grade dysplasia or carcinoma. Laparotomy was performed in 17 cases and laparoscopy in nine cases. Preoperative endoscopic local treatment with argon coagulation was performed in one patient. RESULTS: Clinical mean follow-up was 78 months and endoscopic mean follow-up was 59.3 months. No increase in the length of the Barrett's epithelium was observed. Seven patients (27%) had complete or partial regression (among them three patients with tongue lesions and one patient preoperatively treated by argon). No patients developed high-grade dysplasia or carcinoma. CONCLUSION: Regression of Barrett's esophagus is possible but not frequent and unpredictable after antireflux procedure. However, endoscopic and histological surveillance should be continued postoperatively.

[Abdominal tuberculosis of pseudotumor aspect]. / Tuberculose abdominale d'allure pseudo-tumorale.

BACKGROUND: Abdominal tuberculosis is rarely encountered in developed countries, representing less than 1% of all forms of tuberculosis. There has however been a revival over the last few years. CASE REPORTS: The initial diagnoses suspected in two young multiparous patients who had immigrated to France were malignant lymphoma and ovarian carcinoma. After the final diagnosis of abdominal tuberculosis was made, the clinical course rapidly improved. DISCUSSION: Any abdominal organ may be involved in this localization of tuberculosis, but symptoms are not specific and diagnosis can often be missed. Tumor-forming abdominal mass is an exceptional finding and often mimics malignancy. Clinicians should be aware of this localization, particularly in light of epidemiological features, and examine all modern diagnostic procedures.

[Portasystemic anastomosis by transjugular approach: treatment of active and refractory hemorrhage caused by rupture of esophageal varices. Results in 11 patients]. / Anastomose porto-systémique par voie transjugulaire: traitement de l'hémorragie par rupture de varices oesophagiennes active et réfractaire. Résultats chez 11 malades.

OBJECTIVE: The aim of this study was to assess the feasibility and efficacy of transjugular intrahepatic portosystemic shunts for refractory variceal bleeding, uncontrolled by sclerotherapy or endoscopic ligation. METHODS: 11 patients (mean age: 52 years) with cirrhosis admitted for refractory haemorrhage from ruptured oesophageal varices were included in this study. Eight patients were Child-Pugh class C. All patients were actively bleeding. RESULTS: All the procedures were successful. Variceal haemorrhage stopped within 24 h. There was no mortality during the procedure. Early complications such as rebleeding (18%) and thrombosis (18%) occurred. Thirty days mortality was 27%. Follow-up in the 8 surviving patients was 19.5 +/- 8 months. Three patients developed recurrent bleeding, from non-variceal sources in 2. In 4 surviving patients, occlusion of the shunt was treated with dilatation or insertion of a second stent. The incidence of hepatic encephalopathy was 25%. Five patients subsequently underwent liver transplantation. Among the 3 patients ineligible for transplantation, one died of hepatocellular carcinoma after 10 months. The 2 others were alive after 19 and 25 months, respectively. CONCLUSIONS: These results suggest that transjugular intrahepatic portosystemic shunt is a safe and effective procedure of portal decompression in patients with refractory variceal bleeding. Prospective trials comparing this percutaneous procedure and surgical treatment are required.

[Endoscopic ligation of esophageal varices: prevention of hemorrhagic recurrences caused by rupture of esophageal varices. Results in 45 patients]. / Ligature endoscopique des varices oesophagiennes: prévention des récidives hémorragiques par rupture de varices oesophagiennes. Résultats chez 45 malades.

OBJECTIVES: The aim of this study was to assess the morbidity and efficacy of endoscopic variceal ligation for the prophylaxis of rebleeding from oesophageal varices. METHODS: Forty-five patients with cirrhosis (Child's class: A: 18, B: 16, C: 11) and recent (< 48 h) variceal bleeding were included. Eleven of the patients were included after failure of sclerotherapy. All patients were treated by endoscopic ligation until the complete eradication of oesophageal varices. The mean follow-up was 8.7 +/- 6.8 months. RESULTS: Oesophageal varices were eradicated in 40 patients (89%) after an average of 2 sessions (range: 1-5). In a subset of 11 patients treated after failure of sclerotherapy, 8 (73%) had complete eradication of oesophageal varices. Six of the 45 patients (13%) had recurrence of haemorrhage, due to post-ligation ulcerations in 5 cases and to rupture of oesophageal varices in one case. The rate of complications was 7%. Of the 40 patients whose oesophageal varices were eradicated, 7 (17%) were lost for follow up, and another treatment was performed in 4 (10%): liver transplantation in 2, and transjugular intrahepatic portosystemic shunt in 2. Recurrence of oesophageal varices after eradication was observed in 3 (10%) of the remaining 29 patients after a follow-up of 8.9 +/- 12.9 months. Of these 3 patients, only one (3%) presented with recurrence of haemorrhage due to ruptured oesophageal varices. Three patients (7%) died before eradication of oesophageal varices from causes unrelated to the technique. CONCLUSION: This study confirms that endoscopic ligation is effective for eradication of oesophageal varices, with a low morbidity. This technique appears to be a method of choice in the prophylaxis of rebleeding from oesophageal varices, especially when sclerotherapy is ineffective.

The French experience of treatment of chronic type D hepatitis with a 12-month course of interferon alpha-2B. Results of a randomized controlled trial.

Hepatitis due to hepatitis delta virus (HDV) infection is generally associated with severe histological abnormalities and rapid progression of the disease. To assess the efficacy of recombinant interferon-a2b in treatment of chronic delta hepatitis, 22 patients were entered into a randomized controlled trial: 11 received interferon-a2b subcutaneously three times weekly for 12 months (5 MU/m2 for 4 months and then 3 MU/m2 for a further 8 months) and 11 were untreated. All patients were followed up for 6 months after the completion of therapy. Nine treated patients completed the trial: one was withdrawn with hyperthyroidism and one committed suicide. Serum ALT levels were normalized or significantly reduced, always within 3 months of initiating treatment, and remained so in 73% of treated patients at the 4th month and in 54.5% at the 12th month, compared with 18% and 18%, respectively, in the untreated group. Moreover, in seven of nine treated patients, interferon was associated with the clearance of serum HDV-RNA, associated with amelioration of the histological picture, whereas this occurred in only four of 11 untreated patients. On cessation of therapy, all patients but one experienced a biological and/or virological relapse over the 6-month follow up. In conclusion, our data confirm that HDV is sensitive to inhibition by interferon-a2b, although the schedule used did not achieve permanent control of the disease. The adverse effects of interferon require consideration; in particular, care will be needed to avoid serious psychiatric side effects.

Clinical relevance of the detection of hepatitis delta virus RNA in serum by RNA hybridization and polymerase chain reaction.

Hepatitis delta virus nucleic acid was detected by dot-blot hybridization using RNA probe and reverse transcription/polymerase chain reaction amplification in 223 serum samples from 66 patients with hepatitis D virus infection. Seven cases with chronic hepatitis D virus infection were treated with interferon: six for 3 months and one for 7.5 years. By using the primers located in the putative conserved regions, the technique of reverse transcription/polymerase chain reaction amplification was 10(3) to 10(4) times more sensitive than that of dot-blot hybridization. The main findings of this study are: (i) HDV RNA could be detected in the absence of any other serological hepatitis D virus marker in serum from acute hepatitis patients with IgM anti-HBc; (ii) high titer anti-HD antibodies (IgM and total anti-HD) persisted in patients during short-term interferon treatment, and in one patient during long-term interferon treatment, despite clearance of serum HDV RNA even after 3 years; (iii) total anti-HD alone was detected in the absence of IgM anti-HD and serum HDV RNA. These observations indicate that the detection of HDV RNA by molecular techniques in serum is a useful, sensitive and non-invasive technique for the early diagnosis and follow up of hepatitis D virus infection, as well as for the monitoring of antiviral therapy. In addition, total anti-HD antibody in the absence of HDV RNA may be the only residual marker of past infection. Finally, the choice of the technique for hepatitis D virus detection is important for the optimal assessment of the clinical stage and monitoring of antiviral therapy in hepatitis D virus-infected patients.