1
April 1995 AASLD Al163 EFFICACY OF LOW DO6E ALFA INTERFERON THERAPY IN HBV RELATED CHRONIC LIVER DISEASE IN ASIAN INDI- ANS: A RANDOMIZED TRIAL S.K.Sarin R.C.Guptan, V. Thakur, S. Malhotra, K. Banerjee, P. Khandekar, Dept. of Gastroenterology, G.B.Pant Hospital and Gene Expression Lab, New Delhi. Interferon therapy has been shown to be effec- tive in 40-60% of the Western patients with chron- ic hepatitis due to hepatitis H viral (HBV) infec- tion; but to a much lesser degree in Asian Chi- nese. Its efficacy in the Asian Indian subjects with chronic HEV infection is not known. 46 pa- tients with HBV related chronic liver disease were randomized to receive either (a) recombinant alpha 2b interferon (n=23) 3 MIU, sc, thrice a week for 4 months, or (bl no treatment (n=23). The IFN and the control groups were comparable in age (27±15 vs. 36± 8 yr), sex (male : female: 18:5 in each group) and ALT levels (172±41 vs. 134±48, p=NS). All the patients completed the therapy. The pa- tients were followed-up for 12 more months. Results: In the IFN group compared with the con- trol group, loss of HBV DNA (57% vs. 5%, p<0.01) and HBeAg (50% vs. 5%, p<0.05) was significantly higher. The seroconversion to antiHBe was seen in 35% of the treated and 5% of the control patients (p<0.05); specially higher in patients with chron- ic hepatitis than with cirrhosis. In the respon- ders, ALT levels nearly normalized. One year after interferon therapy, the overall HBeAg and HHV DNA clearance was observed in 69% patients, with HBsAg clearance in 16%. Reactivation was not seen in any patient. Side-effects were transient and minimal. Conclusion: (i) Recombinant alpha interferon therapy is quite effective and safe in Asian Indians with chronic liver disease due to hepati- tis B infection (ii) low dose interferon therapy is recommended for Asian Indian patients. • RANDOMIZED PROSPECTIVE TRIAL OF ENDOSCOPIC SCLERO- THERAPY (EST) VS. VARICEAL LIGATION (EVL) FOR BLEEDING ESOPHAGEAL VARICES: influence on gastrop- athy, gastric varices and recurrence. Sarin SK Govil A, Jain A, Guptan RC, Murthy NS. Dept. Gastroenterology, G.B.Pant Hosp. & ICPO, Delhi EVL has been recommended to be safer than EST for prevention of variceal rebleeding. To assess the efficacy and influence on development of portal hypertensive gastropathy (PGP) and gastric varices, 95 variceal bleeders were randomized to receive weekly EST with alcohol (n=48) or EVL (n=47). The EST and EVL groups were comparable: (cirrhosis 31:34, non-cirrhotics 17:23), Child's grade (A 24:22; B 18:18; C 6:7) variceal grade (GrlI 1:2; grIII; 27:21; grIV 20:15). Data was analyzed using acturial methods. Results: In the arrest of acute bleed, EST (6 of 7, 86%) and EVL (4 of 5, 80%) were comparable. EVL compared to EST, could obliterate esophageal varices in fewer treatment sessions (4.1±1.2 vs. 5.2±1.8, p<0.01) and shorter time (4.4±1.3 vs. 6.9±3.4 wk, p<0.01). Three (6.4%) patients bled after EVL and I0 (20.8%) after EST (p<0.05). During a mean follow- up of 8.5±4.4 mo, variceal recurrence was common- er after EVL (21.3%) than EST (6.3%,p<0.05). Esophageal strictures occurred in 5 (10.4%) pa- tients after EST, but none after EVL. Eight (8.4%) patients had PGP at presentation. Significant additional patients developed PGP after EST than EVL (20.5% vs. 2.3%; p = 0.02). Both EST (50%) and EVL (53%) were effective in obliterating lesser curve gastric varices. Recurrence as gastric varices was seen in 4 (8.8%) patients in either group. 3 (6.3%) patients died in each group. Two died due to rebleed in EST but none in EVL group. Conclusions: (i) EVL achieves variceal oblitera- tion faster with fewer sessions (il) EVL had a lower frequency of rebleed and development of PGP (iii) While both treatments are good for arresting acute bleed and gastric varices, variceal recur- rence is more following EVL than EST. • MICROWAVE COAGULATION THERAPY FOR HEPATOCELLULAR CARCINOMA. M. Sato. Y. Nakata, K. Kito, S. Horiuchi, T. Yamamoto, Y. Watanabe, S. Kimura. Dept. of Surgery II, University of Ehime, School of Medicine, Ehime, Japan The purpose of this study is to evaluate the efficacy of microwave coagulation therapy (MCT) for hepatocellular carcinoma (HCC) which was currently introduced as a new treatment option. Patients and Methods: Nineteen patients with HCC underwent MCT for 30 nodules. The indications were impaired hepatic function and/or scattered intrahepatic metastases (n=9), remaining satellite lesions after hepatic resection (n=5), reduction of tumor burden (n=3), etc. Sixteen patients had liver cirrhosis. The nodules were located in the right lobe in 9 patients, bilateral lobe in seven, and left in three. A microwave irradiation (Microtase, Osaka, Japan) at 70-80 watts, 30 sec., consistently creates a columnar necrosis, 10 mm in diameter, around a needle electrode. We repeated irradiation to create a segmental necrosis containing the main tumor and surrounding liver parenchyma which provides a tumor-free margin. When a treated area represents a sharply demarcated non-enhanced region on postoperative CT, MCT was considered to be complete. Results: The number of nodules treated with MCT was single in 13 patients, and 2-5 in six. The tumor sizes averaged 21 mm (4-90 mm). The approaches included laparotomy (n=l 1), taparoscopy (n=5), thoraco-laparotomy (n=2), and thoracotomy (n=l). Although liver enzymes temporally increased, there were no major complications. CT proves that 27 of the 30 lesions were completely treated. Of the 30 nodules, 28 developed no recurrence. Two nodules progressed because laparoscopic punctures failed to coagulate the entire lesion. Four patients died of hepatic insufficiency (n=2), intrahepatic recurrence (n=l), distant metastases (n=l). Fifteen patients including two long-term survivors are alive 3-52 mos after MCT. Conclusions: We concluded that MCT offers a promising new option as a curative treatment or an alternative to hepatic resection in the treatment of HCCs associated with liver cirrhosis because of its safety, feasibility, and validity. DIFFERENT AFFINITY TO LENS CULINARIS AGGLUTININ ( LCA ) BETWEEN HEPATOCELLULAR CARCINOMA(HCC) AND NON-HCC CELL J Satoi, A Sanjo, Y Takekuma, T Nekohashi, T Abe, K Komiyama, T Ui, S Morimoto, T Tanaka Department of Internal Medicine ( I ), Daisan Hospital, The Jikei University School of Medicine, Tokyo, Japan Previous studies have reported that serum glycoprotein of c(-fetoprotein, PIVKA-II, or 0tl-antitrypsin has microheterogeneity in affinity to lectins in patients having malignant tumor, which induce the accurate diagnosis of malignant tumor. This heterogeneity indicates changing in the carbohydrate moiety during the progress toward malignant tumor. In present study, we investigated the affinity of LCA between parenchymal liver non-tumor and tumor cell using histochemical techniques. Biopsied non-tumor and tumor tissues were obtained from 92 patients with chronic liver disease complicated with HCC, and biotinylated LCA were applied to these paraffin-embedded tissues, being followed by ABC staining. Positive staining of LCA in cytoplasm of parenchymal cells was examined light -microscopically. Chronic inflammatory changes (CI) including cirrhosis, adenomatous hyperplasia (AH), well-differentiated HCC (W-HCC), and moderately-differentiated HCC (M-HCC) were histologically diagnosed. Some tissues were stained with biotinylated LCA and then with gold-conjugated streptavidin, and were examined by a electron microscope. These results are shown as follows: Po~sitiv~ CI A H W-HCC [M-HCC LCA staining 92 12 20 0 [Negative LCA staining 0 0 23 37 Both above light- and electron- microscopic observations suggest that CI, AH and some of W-HCC had more positive LCA staining than W-HCC and M-HCC. In conclusion, HCC is likely to be sequentially developed from inflammatory conditions and thus the carbohydrate recognized by LCA decrease during the progress toward HCC.

Randomized prospective trial of endoscopic sclerotherapy (EST) vs. variceal ligation (EVL) for bleeding esophagel varices: influence on gastropathy, gastric varices and recurrence

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Page 1: Randomized prospective trial of endoscopic sclerotherapy (EST) vs. variceal ligation (EVL) for bleeding esophagel varices: influence on gastropathy, gastric varices and recurrence

April 1995 AASLD A l163

EFFICACY OF LOW DO6E ALFA INTERFERON THERAPY IN HBV RELATED CHRONIC LIVER DISEASE IN ASIAN INDI- ANS: A RANDOMIZED TRIAL S.K.Sarin R.C.Guptan, V. Thakur, S. Malhotra, K. Banerjee, P. Khandekar, Dept. of Gastroenterology, G.B.Pant Hospital and Gene Expression Lab, New Delhi.

Interferon therapy has been shown to be effec- tive in 40-60% of the Western patients with chron- ic hepatitis due to hepatitis H viral (HBV) infec- tion; but to a much lesser degree in Asian Chi- nese. Its efficacy in the Asian Indian subjects with chronic HEV infection is not known. 46 pa- tients with HBV related chronic liver disease were randomized to receive either (a) recombinant alpha 2b interferon (n=23) 3 MIU, sc, thrice a week for 4 months, or (bl no treatment (n=23). The IFN and the control groups were comparable in age (27±15 vs. 36± 8 yr), sex (male : female: 18:5 in each group) and ALT levels (172±41 vs. 134±48, p=NS). All the patients completed the therapy. The pa- tients were followed-up for 12 more months. Results: In the IFN group compared with the con- trol group, loss of HBV DNA (57% vs. 5%, p<0.01) and HBeAg (50% vs. 5%, p<0.05) was significantly higher. The seroconversion to antiHBe was seen in 35% of the treated and 5% of the control patients (p<0.05); specially higher in patients with chron- ic hepatitis than with cirrhosis. In the respon- ders, ALT levels nearly normalized. One year after interferon therapy, the overall HBeAg and HHV DNA clearance was observed in 69% patients, with HBsAg clearance in 16%. Reactivation was not seen in any patient. Side-effects were transient and minimal. Conclusion: (i) Recombinant alpha interferon therapy is quite effective and safe in Asian Indians with chronic liver disease due to hepati- tis B infection (ii) low dose interferon therapy is recommended for Asian Indian patients.

• RANDOMIZED PROSPECTIVE TRIAL OF ENDOSCOPIC SCLERO- THERAPY (EST) VS. VARICEAL LIGATION (EVL) FOR BLEEDING ESOPHAGEAL VARICES: influence on gastrop- athy, gastric varices and recurrence. S a r i n SK Govil A, Jain A, Guptan RC, Murthy NS. Dept. Gastroenterology, G.B.Pant Hosp. & ICPO, Delhi

EVL has been recommended to be safer than EST for prevention of variceal rebleeding. To assess the efficacy and influence on development of portal hypertensive gastropathy (PGP) and gastric varices, 95 variceal bleeders were randomized to receive weekly EST with alcohol (n=48) or EVL (n=47). The EST and EVL groups were comparable: (cirrhosis 31:34, non-cirrhotics 17:23), Child's grade (A 24:22; B 18:18; C 6:7) variceal grade (GrlI 1:2; grIII; 27:21; grIV 20:15). Data was analyzed using acturial methods. Results: In the arrest of acute bleed, EST (6 of 7, 86%) and EVL (4 of 5, 80%) were comparable. EVL compared to EST, could obliterate esophageal varices in fewer treatment sessions (4.1±1.2 vs. 5.2±1.8, p<0.01) and shorter time (4.4±1.3 vs. 6.9±3.4 wk, p<0.01). Three (6.4%) patients bled after EVL and I0 (20.8%) after EST (p<0.05). During a mean follow- up of 8.5±4.4 mo, variceal recurrence was common- er after EVL (21.3%) than EST (6.3%,p<0.05). Esophageal strictures occurred in 5 (10.4%) pa- tients after EST, but none after EVL. Eight (8.4%) patients had PGP at presentation. Significant additional patients developed PGP after EST than EVL (20.5% vs. 2.3%; p = 0.02). Both EST (50%) and EVL (53%) were effective in obliterating lesser curve gastric varices. Recurrence as gastric varices was seen in 4 (8.8%) patients in either group. 3 (6.3%) patients died in each group. Two died due to rebleed in EST but none in EVL group. Conclusions: (i) EVL achieves variceal oblitera- tion faster with fewer sessions (il) EVL had a lower frequency of rebleed and development of PGP (iii) While both treatments are good for arresting acute bleed and gastric varices, variceal recur- rence is more following EVL than EST.

• MICROWAVE COAGULATION THERAPY FOR HEPATOCELLULAR CARCINOMA. M. Sato. Y. Nakata, K. Kito, S. Horiuchi, T. Yamamoto, Y. Watanabe, S. Kimura. Dept. of Surgery II, University of Ehime, School of Medicine, Ehime, Japan

The purpose of this study is to evaluate the efficacy of microwave coagulation therapy (MCT) for hepatocellular carcinoma (HCC) which was currently introduced as a new treatment option.

Patients and Methods: Nineteen patients with HCC underwent MCT for 30 nodules. The indications were impaired hepatic function and/or scattered intrahepatic metastases (n=9), remaining satellite lesions after hepatic resection (n=5), reduction of tumor burden (n=3), etc. Sixteen patients had liver cirrhosis. The nodules were located in the right lobe in 9 patients, bilateral lobe in seven, and left in three. A microwave irradiation (Microtase, Osaka, Japan) at 70-80 watts, 30 sec., consistently creates a columnar necrosis, 10 mm in diameter, around a needle electrode. We repeated irradiation to create a segmental necrosis containing the main tumor and surrounding liver parenchyma which provides a tumor-free margin. When a treated area represents a sharply demarcated non-enhanced region on postoperative CT, MCT was considered to be complete.

Results: The number of nodules treated with MCT was single in 13 patients, and 2-5 in six. The tumor sizes averaged 21 mm (4-90 mm). The approaches included laparotomy (n=l 1), taparoscopy (n=5), thoraco-laparotomy (n=2), and thoracotomy (n=l). Although liver enzymes temporally increased, there were no major complications. CT proves that 27 of the 30 lesions were completely treated. Of the 30 nodules, 28 developed no recurrence. Two nodules progressed because laparoscopic punctures failed to coagulate the entire lesion. Four patients died of hepatic insufficiency (n=2), intrahepatic recurrence (n=l), distant metastases (n=l). Fifteen patients including two long-term survivors are alive 3-52 mos after MCT.

Conclusions: We concluded that MCT offers a promising new option as a curative treatment or an alternative to hepatic resection in the treatment of HCCs associated with liver cirrhosis because of its safety, feasibility, and validity.

DIFFERENT AFFINITY TO LENS CULINARIS AGGLUTININ ( LCA ) BETWEEN HEPATOCELLULAR CARCINOMA(HCC) AND NON-HCC CELL J Satoi, A Sanjo, Y Takekuma, T Nekohashi, T Abe, K Komiyama, T Ui, S Morimoto, T Tanaka Department of Internal Medicine ( I ) , Daisan Hospital, The Jikei University School of Medicine, Tokyo, Japan

Previous studies have reported that serum glycoprotein of c(-fetoprotein, PIVKA-II, or 0tl-antitrypsin has microheterogeneity in affinity to lectins in patients having malignant tumor, which induce the accurate diagnosis of malignant tumor. This heterogeneity indicates changing in the carbohydrate moiety during the progress toward malignant tumor. In present study, we investigated the affinity of LCA between parenchymal liver non-tumor and tumor cell using histochemical techniques. Biopsied non-tumor and tumor tissues were obtained from 92 patients with chronic liver disease complicated with HCC, and biotinylated LCA were applied to these paraffin-embedded tissues, being followed by ABC staining. Positive staining of LCA in cytoplasm of parenchymal cells was examined light -microscopically. Chronic inflammatory changes (CI) including

cirrhosis, adenomatous hyperplasia (AH), well-differentiated HCC (W-HCC), and moderately-differentiated HCC (M-HCC) were histologically diagnosed. Some tissues were stained with biotinylated LCA and then with gold-conjugated streptavidin, and were examined by a electron microscope. These results are shown as follows:

Po~sitiv~ CI A H W-HCC [M-HCC LCA staining 92 12 20 0

[Negative LCA staining 0 0 23 37

Both above light- and electron- microscopic observations suggest that CI, AH and some of W-HCC had more positive LCA staining than W-HCC and M-HCC. In conclusion, HCC is likely to be sequentially developed from inflammatory conditions and thus the carbohydrate recognized by LCA decrease during the progress toward HCC.