Prevalence and predictive factors of the need for surgery for advanced colorectal adenoma.

AIM: Endoscopic resection is the primary treatment for colorectal adenoma, but in some cases surgery is necessary. The aim of this retrospective study was to define the prevalence and predictive factors for surgery in patients with advanced colorectal adenoma managed in a referral endoscopy centre. METHOD: Consecutive patients diagnosed with advanced adenoma (Class 4 in the Vienna classification) during a colonoscopy from 2007 to 2009 in the endoscopy centre of the University Hospital of Rennes were included. Predictive factors of surgery were determined by univariate and multivariate analysis. RESULTS: Two-hundred and twelve (135 male) patients with a mean age of 65.8 years were included. The reason for colonoscopy was for diagnosis in 63.2%, surveillance in 25.5% and screening in 11.3%. These referred patients amounted to 20.8% of all patients having colonoscopy. Surgery was performed in 13.7% of the 212 patients and in 16 (8.3%) of the 192 patients in whom endoscopic removal was attempted. In the subgroup of 192 patients, univariate analysis revealed that body mass index (P = 0.04), histology (P = 0.002), size (P = 0.03) and macroscopic appearance (P < 0.001) of the polyp were associated with surgery. Multivariate analysis revealed that the macroscopic appearance and histology only were significantly associated with surgery. CONCLUSION: Surgery was needed in 13.7% of patients with an advanced adenoma, but in only 8.3% of the subgroup of 192 patients in whom endoscopic removal was attempted. Factors associated with surgery included macroscopic appearance and histology.

Incontinence in full-thickness rectal prolapse: low level of improvement after laparoscopic rectopexy.

AIM: The study aimed to quantify incontinence before and after laparoscopic rectopexy in patients suffering from rectal prolapse. METHOD: Eighty-five patients underwent laparoscopic rectopexy to treat rectal prolapse between 2003 and 2009. Symptomatic and functional data were collected prospectively before and after surgery by self-administered questionnaires including the Cleveland Clinic Fecal Incontinence Score (CCIS) and constipation, gastrointestinal quality of life and urinary incontinence questionnaires. Incontinence was considered to be present when the CCIS remained at ≥ 5 after surgery. RESULTS: After a mean follow-up period of 36 months after surgery, 83% of the patients reported good to excellent results. Continence was improved in 58 (68%), with a significant decrease in the continence score (-3.4 ± 5.8, P = 0.001). However, 50 (58.9%) patients remained incontinent: 47 (55%) reported urge incontinence and 27 (32%) had passive leakage. Incontinence for liquid stool, incontinence for solid stool and the need for protection was seen in 43 (51%), 35 (41%) and 43 (51%) patients. Manometry, defaecography and ultrasonography were not associated with any improvement. In contrast, the patients' average age (60.2 ± 15.8 vs 46.9 ± 15.5 years; P = 0.003), symptom duration before surgery (58.1 ± 70.1 vs 29.5 ± 33.3 months; P = 0.011), preoperative urinary incontinence score (10.7 ± 10.8 vs 4.2 ± 5.7; P = 0.0131) and faecal incontinence score (12.9 ± 4.9 vs 7.1 ± 6; P < 0.0001) were significantly higher in patients suffering from postoperative incontinence. CONCLUSION: Despite some continence improvement in two-thirds of patients who underwent surgery for rectal prolapse, the level of improvement remained low in more than half of the patients.

Underlying functional bowel disorder may explain patient dissatisfaction after haemorrhoidal surgery.

AIM: The aim of this study was to assess patient dissatisfaction and functional symptoms following haemorrhoid surgery, aspects of which are seldom covered in other published series. METHOD: A self-administered questionnaire was mailed to 359 consecutive patients (prospective database; 198 men, 161 women; median follow up, 59 [1-120] months) who underwent either Milligan-Morgan haemorrhoidectomy (n=205) or stapled haemorrhoidopexy (n=154). RESULTS: The response rate was 72%; 2.4% of patients had no opinion, 13.6% were dissatisfied, 33.0% were satisfied, and 51.0% were very satisfied with the treatment. Dissatisfied patients were more likely to be women and more likely to have a long history of constipation and irritable bowel syndrome. The duration of surgery and the rates of pre- and postoperative complications did not differ between groups. Residual bleeding (49% vs 32%), prolapse (67% vs 31%) and pain (91% vs 55%) occurred more frequently in the dissatisfied group compared with the satisfied group (P<0.001). Incontinence (4 [0-16] vs 1 [0-15]; P=0.0003) and constipation (19 [1-34] vs 8 [0-31]; P<0.0001) scores were significantly higher in the dissatisfied group compared with satisfied patients. Anal pain was the predominant symptom associated with dissatisfaction in a logistic regression model. CONCLUSION: Persistent pain remains the major long-term factor associated with dissatisfaction after surgery for haemorrhoids.

[Diagnosis of dyschezia]. / Stratégie diagnostique d'une dyschésie.

Outlet constipation is a frustrating condition for both patients and clinicians. The former are reluctant to evoke this disabling condition. For the latter, decision-making remains uncertain since non-specific strategies are unhelpful (constipation). Thus, careful symptomatic assessment (stool consistencies), dynamic examination of the anorectal area (anismus, rectocele) and balloon expulsion test may plan therapeutic options in current situations.

Colonoscopy results of a French regional FOBT-based colorectal cancer screening program with high compliance.

BACKGROUND AND STUDY AIMS: Mass screening for colorectal cancer in France was initiated in pilot regions on the basis of the fecal occult blood test (FOBT) followed by colonoscopy in positive cases. We report the colonoscopy results in one of the first areas to be screened (Ille et Vilaine). PATIENTS AND METHODS: Of the total regional population of 908,449, 187,342 of the 213,635 potential screening candidates who were aged 50 - 74 years were invited for FOBT. Of the 51.3% compliant individuals, 2.6% were positive, and of these 90.7% agreed to undergo colonoscopy (n = 2246). The colonoscopy procedure details, findings, and complications were recorded. Subjects were classified according to the most advanced lesion. Positive predictive values of FOBT were calculated according to sex and age. RESULTS: Colonoscopy was complete in 96.3% of cases. Only 23 adverse events were encountered (1.02%). Colorectal cancer was diagnosed in 237 cases (10.6%, 78.4% of which were clinical stages I - II). The rates of overall adenomas and advanced adenomas were 33.1 % and 21.6 %, respectively. The risk of cancer and advanced adenoma increased significantly in men and in older people. CONCLUSION: The results of mass screening with FOBT followed by colonoscopy in this population-based study are very encouraging in terms of compliance, early findings, and complications. Extension of this program to the whole of France is justified.

Management of gastroesophageal reflux disease by primary care physicians and gastroenterologists: a prospective study of patients' records.

BACKGROUND: We previously compared the perceptions and practices of primary care physicians (PCP) and gastroenterologists (GE) in the management of gastroesophageal reflux disease (GORD), but the data were only declarative statements. OBJECTIVE: The aim of the present study was to analyze the respective management of GORD by PCP and GE on the basis of patients' records, and to look for any discrepancies between the declared and actual practices in both groups of physicians in the management of GORD. METHODS: A representative sample of French physicians was asked to enroll two consecutive patients with frequent and typical symptoms of GORD into a prospective observational survey. RESULTS: A total of 136 PCP and 91 GE participated in the survey and enrolled 271 and 182 patients, respectively, with frequent GORD symptoms (453 patients in total). Patients consulting GE were slightly younger, and had waited longer before arranging a consultation despite having symptom severity and impact on daily life similar to those visiting PCP. Most patients enrolled by GE had undergone upper GI endoscopy (95% versus 64% from PCP, P<0.01). In both groups of physicians, recourse to endoscopy for their patients was more frequent than they estimated. Prescription therapies for GORD were usually Proton Pump Inhibitors (PPI) in both groups of physicians and were in keeping with the declared findings. CONCLUSIONS: Despite differences between patients' characteristics, the management of frequent GORD was similar by both groups of physicians. The reasons why both groups of physicians underrated their actual recourse to endoscopy for their patients warrant further investigation.

Transition of patients with inflammatory bowel disease from pediatric to adult care.

AIM: This study was designed to ascertain the perception of patients (and their parents) followed-up for inflammatory bowel disease (IBD) concerning the transition from pediatric to adult care. PATIENTS AND METHODS: Forty-eight youths with IBD who had transited from pediatric to adult care were surveyed. Their age at transition was 17.9+/-0.9 years. Thirty-four patients (71%) had been referred to a gastroenterologist working in the same hospital and, in 27 cases, after having attended a joint pediatric-adult care visit. RESULTS: The response rate was 71%. Twenty-nine patients (85%) and 25 parents (74%) felt they were ready to transit into adult care. Seven patients (22%) and 10 parents (32%) were apprehensive about transition to adult gastroenterology. All patients considered the joint medical visit beneficial in terms of transmitting information from their medical records and 93% considered it beneficial for building confidence in the new gastroenterologist. All parents considered the joint medical visit helpful for building the children's confidence in their new doctor. At the time of the survey, 29 patients (85%) were continuing to be followed-up by the same gastroenterologist. CONCLUSION: Effective planning, including a joint medical visit, enabled successful, well-coordinated transition to adult medical-care follow-up.

Gastric involvement in juvenile polyposis associated with germline SMAD4 mutations: an entity characterized by a mixed hypertrophic and polypoid gastropathy.

Exclusively gastric form of juvenile polyposis associated with germline SMAD4 mutation is a rare clinical entity and is usually difficult to diagnose in the absence of colorectal lesions. We describe the phenotype of two unrelated cases of exclusive or predominant gastric expression of juvenile polyposis. Endoscopically, we found an unusual hypertrophic and polypoid gastropathy with abundant mucus adhering to the mucosal surface. Initially diagnosed as hyperplastic polyps, examination of gastric macrobiopsy specimens and identification of SMAD4 gene mutation in both cases confirmed the diagnosis. Close upper GI surveillance was proposed in case 1 and prophylactic total gastrectomy in the second one. Juvenile polyposis limited to the stomach is a rare condition that is linked to SMAD4 mutations. Such a diagnosis should be considered whenever a mixed, hypertrophic and polypoid gastropathy is encountered.

[Pseudomalignant endoscopic appearance in hyperplastic polyp at esophagogastric junction: case report]. / Aspect endoscopique pseudocarcinomateux d'un polype hyperplasique au niveau de la jonction oesogastrique: à propos d'un cas.

Hyperplastic polyps are by far the most common benign tumors in the stomach larger than 5mm. Although the malignant potential of hyperplastic gastric polyps was originally denied, a low risk for carcinomatous conversion is now recognized. Its has been recommended that all gastric polyps of 5mm or more in diameter have to be removed. We present here the case of a large hyperplastic gastric polyp located at the esophagogastric junction with endoscopic malignant appearance. The description of its endoscopic and histological characteristics gives us the opportunity to discuss the difficulty of endoscopic diagnosis in the case of gastric polyps and to remind their prognosis.

Perceptions and practices on the management of gastro-oesophageal reflux disease: results of a national survey comparing primary care physicians and gastroenterologists.

BACKGROUND: Literature comparing generalist and specialist care is accumulating in many disease areas, but very few studies focussed on gastrointestinal diseases and little is known about gastro-oesophageal reflux disease. AIM: To compare the management of gastro-oesophageal reflux disease (GERD) by French primary care physicians and gastroenterologists. METHODS: A postal survey was conducted in a representative sample of French physicians who were asked to complete a questionnaire that consisted of 44 questions relating to their usual medical practice for the diagnostic and therapeutic management of frequent GERD. RESULTS: 136 primary care physicians and 91 gastroenterologists participated in the survey (54%). Alarm symptoms were identified more frequently by primary care physicians than gastroenterologists, but the appraisal of their seriousness was less acute by primary care physicians than gastroenterologists. Upper endoscopy was prescribed more frequently by gastroenterologists (64% vs. 38%, P < 0.01). Physicians in both groups mainly recommended lifestyle modification. For GERD treatment, most respondents declared using a 'step-down' strategy with proton pump inhibitors, and only slight differences in drug prescription were identified between primary care physicians and gastroenterologists. Both groups of physicians also have similar perception of symptom persistence after treatment, but satisfaction with treatments was slightly higher for gastroenterologists than primary care physicians (7.6 vs. 7.1 on a scale from 0 to 10, P < 0.01). CONCLUSIONS: Overall patterns of GERD diagnosis and management are comparable between primary care physicians and gastroenterologists. Both groups perceive that GERD therapy can still be improved.

Patients with sporadic duodenal adenoma are a high-risk group for advanced colorectal neoplasia: results of a case-control study.

AIM: To evaluate colorectal cancer risk among patients with sporadic duodenal neoplasia using a case-control protocol. METHODS: Cases were 35 patients referred for the management of sporadic duodenal adenoma and who underwent colonoscopy. Colonoscopy findings among cases were compared with those from a control group matched for age and sex (two controls per case) without duodenal adenoma. Colonoscopy findings were categorized as adenoma, advanced adenoma, cancer or advanced neoplasia. The two groups were compared using the chi-squared test. Odds ratio and 95% confidence intervals were calculated. RESULTS: Colorectal adenoma was present in 31% of cases vs. 24% of controls, advanced neoplasia in 29% vs. 4%, advanced adenoma in 23% vs. 3% and adenocarcinoma in 6% vs. 1%. The relative risks of advanced colorectal adenoma and advanced colorectal neoplasia in cases were 10.1 (95% CI: 1.8-100.1, P = 0.003) and 8.9 (95% CI: 2.1-53.3, P = 0.001), respectively. CONCLUSIONS: The relative risk of advanced colorectal adenoma and advanced neoplasia in cases was nine- to 10-fold that among controls. Patients with sporadic duodenal adenoma represent a high-risk group for advanced colorectal neoplasia and should therefore undergo complete colonoscopy.

[Children with inflammatory bowel disease: Assessment of the transition from the pediatric to the adult care unit]. / Évaluation de la transition pédiatrie-gastroentérologie d'adultes des enfants atteints de maladie inflammatoire cryptogénique intestinale.

AIM: Assess the transition of children followed for inflammatory bowel disease (IBD) to the adult gastroenterology care unit and the development of joint medical visits (JMVs). PATIENTS AND METHOD: This study was conducted at the Rennes University Hospital (Brittany, France). All patients with IBD and relayed to an adult gastroenterologist (GE) between 2000 and 2014 were included. The following medical data were collected: age, gender, clinical status, disease activity, type of follow-up (freelance or at hospital), medical history, disease locations, and treatments received. Patients who were relayed in the same hospital attended a JMV with both the pediatric and adult gastroenterologists. Patients and parents were interviewed with a questionnaire sent by mail. They were asked how they had perceived the transition with questionnaires containing specific items about the JMV. The answers of the patients who attended JMVs were compared to those who did not attend. RESULTS: Eighty-two patients were included. The patient response rate was 56 % (parents, 59 %). The average age at transition was 18±0.8years. Fifty patients were relayed in the same hospital with 30 attending a JMV. These patients suffered from more severe disease than other patients. Thirty-nine patients felt ready to transition (87 %). The JMV was deemed beneficial or very beneficial (74 %) for both follow-up and the benefits of the GE's knowledge of the medical file. The parents' responses did not differ from the patients'. CONCLUSION: Development of the JMV enables a successful transition for pediatric patients with IBD. It could be improved by developing specific therapeutic education sessions based on transition training.

Comparative study of characteristics and disease management between subjects with frequent and occasional gastro-oesophageal reflux symptoms.

BACKGROUND: Little is known about the distinctive characteristics of subjects with frequent (at least weekly) and occasional gastro-oesophageal reflux symptoms. AIM: To compare the characteristics and disease management of subjects complaining of at least weekly and less frequent gastro-oesophageal reflux symptoms. METHODS: Population-based postal survey carried out in France in 2003 among a representative sample of 8000 subjects. RESULTS: The prevalence of frequent and occasional gastro-oesophageal reflux symptoms was 7.8% and 23.4%, respectively. Compared to subjects with occasional gastro-oesophageal reflux symptoms, those with frequent symptoms were older, suffered from more severe symptoms and felt greater impact on daily living, despite a slightly shorter duration of symptoms. These subjects more often sought medical advice. Most of them had treated the last episode of symptoms primarily with a proton-pump inhibitor and less often with antacids/alginates. The degree of treatment satisfaction was lower in subjects with frequent gastro-oesophageal reflux symptoms, in relation to a more frequently observed persistence of symptoms irrespective of the medication used except for proton-pump inhibitors. CONCLUSIONS: This survey suggests that subjects complaining of frequent or occasional gastro-oesophageal reflux symptoms constitute two distinctive groups. Despite greater healthcare use, the former group shows a lower level of satisfaction with disease management. Nevertheless, a substantial subset of subjects with occasional symptoms also complained of impaired health-related quality of life and sought health care.

[Endoscopic therapy for pancreatitis in children]. / Endoscopie interventionnelle dans les pancréatites de l'enfant.

Authors report on 3 cases of children treated by therapeutic endoscopic retrograde cholangiopancreatography for pancreatitis (ERCP). The first child presented with familial pancreatitis: he was treated by sphincterotomy and lithiasis extraction. The second child presented with pancreatitis secondary to pancreas divisum: she was treated by sphincterotomy and stunt of small caroncula. The third child presented with severe pancreatitis with pseudocyst: after drainage she was treated by sphincterotomy, Wirsung dilatation and lithiasis extraction. ERCP is a beneficial treatment and may be alternative to surgery in complicated pancreatitis.

Prospective cohort study of phenotypic variation based on an anal sphincter function in adults with fecal incontinence.

BACKGROUND: One-third of patients with fecal incontinence (FI) do not have any anal dysfunction. The aim was to characterize patients with FI with normal anal function compared with patients with anal weakness. METHODS: The general characteristics and data of anal manometry, endosonography, and defecography of patients who were evaluated for FI at a single institution from 2005 to 2015 were prospectively assessed. Fecal incontinence was defined by the Cleveland Clinic Incontinence Score (CCIS) >4. Anal weakness was defined by one or more of the three following parameters: <25 mmHg at the upper part of the anal canal, <26 mmHg at the lower part of the anal canal, and <60 mmHg for the mean squeeze pressure. KEY RESULTS: A total of 439 patients with FI were included (152 with normal anal function/287 with anal weakness). Severe constipation (Kess score ≥21) was predominant in patients with normal anal function (44/151 vs 50/284, respectively; p = 0.0054). Fecal incontinence with normal anal function was significantly associated with lower age (>63 years; odds ratio [OR] = 0.29), higher weight (>65 kg; OR = 1.69), fecal urgency (OR = 1.58), less severe FI score (CCIS score >10; OR = 0.52), higher abdominal pressure (>36 mmHg; OR = 2.15), and paradoxical puborectal contraction (OR = 2.07) in a multivariate analysis model. CONCLUSION & INFERENCES: Fecal incontinence with normal anal function is a specific phenotype that involves distal constipation and may be an early stage of FI with anal weakness. Physicians should adapt their management to focus on the treatment of constipation.

Low rectal volumes in patients suffering from fecal incontinence: what does it mean?

BACKGROUND: Rectal perception and adaptation to distension are widely heterogeneous in subjects with faecal incontinence. AIM: To quantify rectal physiology in patients with incontinence and low maximum rectal volume, according to AGA guidelines on anorectal testing techniques. PATIENTS AND METHODS: 148 patients (12 men, 136 female) with incontinence to liquid and/or solid stools were investigated. Distending isobaric procedures were carried out using an electronic barostat in order to analyse perception and adaptation of the rectum. RESULTS: Pain during isovolumic rectal distension at a level of 100 mL or less was experienced in 21 subjects (14.2%). As defined by isobaric distensions, incontinent patients with low MTV had more frequently a hypocompliant rectum (62%) when compared with those with higher MTV (31%, P = 0.046). Perception scores tended to be higher at each step of distending rectal pressure: incontinent patients with low MTV had more frequently a hypersensitive rectum (48%) when compared with those with normal or high MTV (24%, P = 0.035). Only four of 21 incontinent subjects with low MTV had an isolated hypersensitive rectum. CONCLUSION: Both sensitivity and compliance are altered in patients with low MTV. A more extensive study of the role of sensory and compliance aspects of subjects with incontinence is warranted.

Routine management of gastro-oesophageal reflux disease by gastroenterologists in France: a prospective observational study.

AIMS: To obtain data on routine care of gastro-oesophageal reflux disease by French gastroenterologists. PATIENTS: Five thousand and forty-five adults with gastro-oesophageal reflux disease. METHODS: Patients were recruited by a representative sample of 598 French gastroenterologists. A full disease history, with treatments given/investigations undertaken, was obtained from all patients. The patients' expectations with regard to the improvement of the symptoms' control and the corresponding assessments made by the gastroenterologists were recorded on a 4-point scale. RESULTS: The mean time since diagnosis was approximately 4 years. The most commonly presented symptom was heartburn (79% of patients). A total of 3735 patients (74%) underwent endoscopy because of gastro-oesophageal reflux disease. Erosive oesophagitis was present in 38% and Barrett's oesophagus in 8%. Medical therapy for gastro-oesophageal reflux disease was prescribed in 92% of patients, of whom 86% received proton pump inhibitors. Lifestyle advice was given to 73% of patients. Overall, 84% of patients and 72% of physicians expected 'highly' or 'moderately' improved control of gastro-oesophageal reflux disease. Gastroenterologists underrated the need for improvement of the symptoms' control as expressed by 'de novo' as well as 'previously diagnosed' patients. CONCLUSIONS: This study provides cross-sectional data on the management of gastro-oesophageal reflux disease by gastroenterologists in France. Most patients have high expectations of an improvement in their management, but gastroenterologists generally underrate these expectations.

Anorectal dysfunction in patients with ulcerative colitis: impaired adaptation or enhanced perception?

BACKGROUND: Rectal disorders during ulcerative colitis (UC) drastically alter the quality of life and may result from an impairment of rectal perception and compliance. This study aims to assess anorectal disorders in patients with mild-to-moderate UC. METHODS: Anal pressures and the rectal responses to phasic rectal isobaric distension in 10 patients with mild-to-moderate UC were prospectively compared with those in 10 healthy volunteers (HVs). KEY RESULTS: The patients in each group were similar regarding age, gender, and delivery. In the resting state, the anal canal pressures were similar between the groups. Only the squeeze pressures of the lower anal canal were significantly lower in UC patients than in HVs. During phasic isobaric distension, rectal sensitivity was similar between the groups, whatever the step of distension. Isobaric rectal distension resulted in a significant decrease of the rectoanal inhibitory reflex and a decrease in rectal tone and a significant drop in rectal compliance in UC patients compared with HVs. CONCLUSIONS & INFERENCES: Patients showing mild-to-moderate UC experience rectal compliance and innervation disorders without a significant change in rectal sensitivity. The findings of this work suggest impairment not only of the properties of the rectal wall but also of intrinsic innervation. Repeated evaluation over time may be helpful for analyzing the reversibility of the process after healing.

Octreotide acts on anorectal physiology: a dynamic study in healthy subjects.

BACKGROUND: Somatostatin is localized in the intestinal and pelvic nerves of the anorectum and it seems to act as an important neurotransmitter. However, previous analyses of octreotide (a somatostatin analog) effects on anal function showed conflicting results. By use of a dynamic model in healthy subjects, with comparison to the myogenic effect of glucagon, the aim of our study was to further investigate the pharmacologic targets of octreotide. METHODS: This was a placebo-controlled, randomized, double-blinded crossover study performed in 12 healthy volunteers who received octreotide, glucagon, or placebo intravenously on separate days. During each sequence, several pressure steps in 3 different protocols of rectal isobaric distension were applied with an electronic barostat. Manometric responses of the anal canal, adaptative volumes, and perception scores of the rectum were recorded. RESULTS: During both phasic and stepwise distensions, a significant drug effect was encountered at the anal level. Compared with placebo, octreotide significantly increased pressures at both upper and lower levels of the anal canal. In contrast, glucagon decreased pressures at the upper part of the anal canal. Octreotide significantly decreased rectal volumes to phasic distension, but glucagon did not induce any change on rectal adaptation. In addition, neither drug modified perception scores. CONCLUSION: This study suggests that octreotide acts on reflex arcs and rectal myenteric neurons rather than on anal myogenic targets that respond to glucagon.

Randomized controlled trial for hepatocellular carcinoma with portal vein thrombosis: intra-arterial iodine-131-iodized oil versus medical support.

UNLABELLED: Portal vein thrombosis is a poor prognostic factor in patients with hepatocellular carcinoma (HCC) and a contraindication for chemoembolization. Intra-arterial injection of 131I-iodized oil which does not modify arterial flow, is feasible in this condition. The aim of this prospective randomized controlled trial was to compare the efficacy of treatment with radiolabeled oil (treated group) versus medical support (control group) in patients with stage I or II HCC (classification of Okuda) with portal vein thrombosis. METHODS: Twenty-seven HCC patients (26 males, 1 female), aged 53-79 yr, with portal vein thrombosis were randomly assigned to Lipiocis group (n = 14) or Control group (n = 13). Additional injections of radiolabeled oil were given 2, 5, 8 and 12 mo after initial therapy. Medical support treatment consisted of: tamoxifen (n = 5), 5 FU intravenously (n = 1), NSAIDs or corticosteroids (n = 5). Efficacy was evaluated according to survival rate (Kaplan-Meier method; log rank test), AFP serum values (measured at 2, 5, 8 and 12 mo) and angiography. RESULTS: The two groups were comparable (Child's classification, Okuda's classification, liver function tests, location of the thrombus). Tolerance was excellent in the Treated group. The actuarial survival curves were significantly different (p < 0.01) between the two groups, the survival rates (Cl 95%) at 3, 6 and 9 mo being 71% (48%-95%), 48% (12%-55%), 7% (1%-31%) for the Treated group; and 10% (1%-33%), 0% and 0% for the Control group. CONCLUSION: Intra-arterial hepatic injection of 131I-labeled iodized oil is a safe and effective palliative treatment of HCC with portal vein thrombosis.