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Self-expanding metal stents for palliation of malignant obstruction in the upper gastrointestinal tract
ESOPHAGUS 7201
?203
SELF-EXPANDING METAL STENTS FOR PALLIATION O F M A L I G N A N T O B S T R U C T I O N IN T H E UPPER GAS T R O I N T E S T I N A L T R A C T . A. May, E.G. Hahn. C. Ell. Department of Medicine I, FAU Erlangen-Nuremberg, Germany
PALLIATIVE TREATMENT FOR ESOPHAGEAL CANCER: ALCOHOL INJECTION, GASTROSTOMY OR ESOPHAGEAL PLASTIC STENT ? M Morais, JB Falcio, L Carvalh0, NM Forones, AP Ferrari Jr. Division of Gastroenterology - Universidade Federal de Sio Paulo -. S~o Paulo - Brazil.
Self-expanding metal stents provide a new option for palliative treatment of malignant stenoses used by tumors of the esophagus. The present study provide a comparative assessment of clinical experience gained consecutively in the implementation of three stent versions in a total of 87 patients and 96 implantations. Methods: 31 Wallstents (5 coated) were implanted in 23 patients, 35 Ultraflex-Stents (uncoated) in another 34 patients and 30 Gianturco-ZStents (all coated) in a group of 30 patients. The three patient groups exhibited no significant differences as to the degree of dysphagia, the number of pretreatments, the length of tumor stenoses, tumor localisation and the histological tumor classification. 7 patients who had been treated with Gianturco-Z-Steots presented an esophago-respiratory fistula. Results: Technically all 96 implantations procedures were succcssfull. Complete sealing of the fistulas was verified by radiography in all patients who had developed fistulas. Severe early complications in the form of stent migration were encountered in only 3 of 96 implantations (3 %) within the first 48 hours. Main problem with the Ultraflex-Stem was the necessity of dilation because of insufficient expansion in about 40 %. The degree of dysphagia improved distinctly and with a comparable development of all three patient groups (score: Wallstent 2,0 to 0,7; UltraflexStem 2,2 to 0,9; Gianturco-Z-Stent 2,1 to 0,7). The median follow up period was 89 days for the wall stent patient group, 108 days for the ultraflex group and 68 days for the Gianturco-Z-stent-group. In the followup-period the stem dislocation rate amounted 4 %. The major problem of the uncoated stents was that of tumor ingrowth in 36 %; whereas the reintervention rate with the Gianturco-Z-stent was 20 %. C o n c l u s i o n s : In the view of the low number of complications (3 %) encounted in the early state of the implantation, serf-expanding metal stents provide improved conditions for palliative therapy of stenoses induced by malignant tumors of the upper GI-wact. Nevertheless, further technologieal improvements are necessary to reduce the high prevalence of unavoidable reinterventions in the follow-up period. The Giantureo-Zstem with an re-intervention rate of 20 % appears to be the most suitable metal stent - not only in case of esophagorespiratory fistulas - to date.
Most of the patients diagnosed with esophageal cancer are in a final stage of the disease and surgical morbidity and mortality are high, and 5 year survival very poor. Aim of the study was to compare three different palliative endoscopic treatments for patients that were not surgical candidates. In a 18 month period, 36 patients were diagnosed as having esophageal cancer at our unit. Twenty four were excluded from the study because very proximal or distal tumor, presence of tracheoesophageal fistula or the patient refused to participate in the study. The remaining 12 patients (1 adenocarcinoma and 11 squamous cell carcinoma) were randomized in 3 groups (4 patients in each group): Group I - alcohol injection, Group II - esophageal plastic stent and Group Ill - endoscopic gastrostomy. Nutritional data (weight, height, % fat, muscle weight) was recorded before treatment and during followup. Kamofsky index, disphagia score and subjective assessment of quality of life were also recorded. Patients were followed until they died (x=2.4 months, range 1-6 months). Only patients in Group III presented with improvement in nutritional status, although disphagia score improved in the other two groups (but anorexia developed in many patients). Complications (stent migration, perfuration and massive bleeding) were more common in Group II, and 2/4 patients in Group I developed tracheo,esophageal fistula. When we analyzed costs (using our reimbursement fees) alcohol injection was the most expensive treatment (g=-U$ 790.00),.compared to gastrostomy (i=U$ 475.00) and plastic stent (~=U$ 375.00). We concluded that gastrostomy is the best treatment to maintain nutritional status in patients with final stage esophageal cancer. Although plastic stent and alcohol injection are efficient in relieving disphagia, patients usually develop severe anorexia, and we could not detect any improvement in their quality of life.
?2o2 ?204
ENHANCED PDT EFFECT IN PATIENTS WITH ESOPHAGEAL CANCER BY LASER LIGHT FRACTIONATION - A PILOT STUDY. H~ Messmann, 1R.M. Szeimies, V. Gross, 1W. B~iumler, 2R. Knfichel, 3H Zimgibl, IM. Landthaler, J. SchSlmerich, A. Holstege. D e p a ~ of lmemal Medicine I, IDermatology, 2pathology and 3Surgery, University of Regensburg, Germany. In a recent study (Messmann et al., Br. J. Cancer.1995; 72: 589-594) we could enhance the PDT effect on normal rat colon after ALA induced photosen~itisation by laser light fractionation: In this pilot study we examined whether this modified laser treatment can also enhance the PDT effect in patients with esophageal cancer after sensitisation with hematoporphyrmes. Methods: 6 patients (4 early and 2 advanced carcinomas, one of these patients with tumor overgrowth of a metal stent) were treated in 9 sessions. In four : sessions laser energy was fractionated to enhance PDT effect using a new hematoperphyrm polyester, Photosan-3 TM (Seehof Laboratorien GmbH, Wesselburen, FRG). 48 hours after sensitisation with 2mg/kg i.v. Photosan-3 TM irradiation was performed with a cylinder diffuser at 630 nm using an argon pumped dye laser (2040 and 375b Spectra Physics L~sers Inc., Moontam View, Califorma, USA). The laser energy of 150J/cm was either applied continuously or fraetionated with a single break of 5 nfins after 75J/cm2 at 100mW. Results; In the group with continuous laser light irradiation there was a complete remission of 2 superficial esophageal cancers in one patient, while the third cancer did not respond. One patient with tumor overgrowth of a metal stent showed a si~nficant tmprovement of dysphagia without destruction of the stent, while in ataother patient with advanced esophageal cancer dysphagia did not improve after centmuous laser treatment. Fractionated laser therapy achieved a complete renussion in all 3 patients with early cancers, one of them did not respond to previous continuous PDT and a partial/'ennssion in a pattent with an uT2 cancer who showed also no rermssion aider continuous PDT However, in the group with fraetionated laser therapy two mild esophageal stenosis occured. Conclusion: Light fractionation during PDT seems to improve the PDT effect in our small number of patients, however, mild esophageal stenosis might be a problem. This modified treatment could be a promising therapy option to reduce the drug dose of HPD and also the side effect of prolonged skin sensitivity.
VOLUME 43, NO. 4, 1996
RECURRENCE RATE IN VARICEAL LIGATION THERAPY FOR ESOPHAGEAL VARICES COMPARED TO ENDOSCOPIC SCLEROTHERAPY: A PROSPECTIVE CONTROLLED TRIAL OF PROPHYLACTIC THERAPY FOR BLEEDING. T. Noda, Y. Gotoh, Y. Sakata, C. Matsunaga, S. Ogata, T. Koyama, H. Sakata, R. Iwakiri, and K. Fujimoto., Dept. of Intern. Med., Saga Med. School, Saga, JAPAN. Since endoscopic variceal ligation therapy (EVL) has been widespread i n treatment of esophageal varices (EV), both its advantage and disadvantage compared to endoscopic injection sclerotherapy (EIS) have attracted notice. To evaluate the efficacy of EVL, we performed a randomized prospective trail to compare the recurrence of EV treated by EVL to that of EIS in cirrhotic patients who underwent prophylactic therapy of EV. Methods. Fifty patients with severe cirrhosis, who were obtained informed consents to receive prophylactic therapy for bleeding of EV, were divided into two groups at random. Group I patients underwent sessions of EVL followed by one or two times EIS. Group II underwent EIS only during the therapeutic sessions. EVL session was performed with endoscopic ligation devices, and EIS session was performed with injection of 5% ethanolamine oleate. Follow-up endoscopic examination was performed 6, 12, and 16 months after the final session. Results. Table. Recurrence rate of EV after the final session.
EVL EIS
6 months
12 months
18 months
36.0%
44.0% * 12.0%
56.0% * 16.0%
8.0%
*
*=P<0.05, comparedto the EIS group. There were no differences in age, sex ratio, etiology of liver cirrhosis, or stage EV between two groups tested. In both groups, complete eradication of EV were achieved at the end of therapeutic sessions. As indicated in Table, the recurrence rate in the EVL group was significantly higher compared to the EIS groups at 6, 12 and 18 months after the final session. Conclusion. The present result showed that the recurrence rate was significantly higher in EVL, even combined with EIS, compared to EIS only. It indicates that EVL is less performed than EIS in regard to long-time efficacy of prophylactic therapy for bleeding of EV.
GASTROINTESTINAL ENDOSCOPY 341
?203
SELF-EXPANDING METAL STENTS FOR PALLIATION O F M A L I G N A N T O B S T R U C T I O N IN T H E UPPER GAS T R O I N T E S T I N A L T R A C T . A. May, E.G. Hahn. C. Ell. Department of Medicine I, FAU Erlangen-Nuremberg, Germany
PALLIATIVE TREATMENT FOR ESOPHAGEAL CANCER: ALCOHOL INJECTION, GASTROSTOMY OR ESOPHAGEAL PLASTIC STENT ? M Morais, JB Falcio, L Carvalh0, NM Forones, AP Ferrari Jr. Division of Gastroenterology - Universidade Federal de Sio Paulo -. S~o Paulo - Brazil.
Self-expanding metal stents provide a new option for palliative treatment of malignant stenoses used by tumors of the esophagus. The present study provide a comparative assessment of clinical experience gained consecutively in the implementation of three stent versions in a total of 87 patients and 96 implantations. Methods: 31 Wallstents (5 coated) were implanted in 23 patients, 35 Ultraflex-Stents (uncoated) in another 34 patients and 30 Gianturco-ZStents (all coated) in a group of 30 patients. The three patient groups exhibited no significant differences as to the degree of dysphagia, the number of pretreatments, the length of tumor stenoses, tumor localisation and the histological tumor classification. 7 patients who had been treated with Gianturco-Z-Steots presented an esophago-respiratory fistula. Results: Technically all 96 implantations procedures were succcssfull. Complete sealing of the fistulas was verified by radiography in all patients who had developed fistulas. Severe early complications in the form of stent migration were encountered in only 3 of 96 implantations (3 %) within the first 48 hours. Main problem with the Ultraflex-Stem was the necessity of dilation because of insufficient expansion in about 40 %. The degree of dysphagia improved distinctly and with a comparable development of all three patient groups (score: Wallstent 2,0 to 0,7; UltraflexStem 2,2 to 0,9; Gianturco-Z-Stent 2,1 to 0,7). The median follow up period was 89 days for the wall stent patient group, 108 days for the ultraflex group and 68 days for the Gianturco-Z-stent-group. In the followup-period the stem dislocation rate amounted 4 %. The major problem of the uncoated stents was that of tumor ingrowth in 36 %; whereas the reintervention rate with the Gianturco-Z-stent was 20 %. C o n c l u s i o n s : In the view of the low number of complications (3 %) encounted in the early state of the implantation, serf-expanding metal stents provide improved conditions for palliative therapy of stenoses induced by malignant tumors of the upper GI-wact. Nevertheless, further technologieal improvements are necessary to reduce the high prevalence of unavoidable reinterventions in the follow-up period. The Giantureo-Zstem with an re-intervention rate of 20 % appears to be the most suitable metal stent - not only in case of esophagorespiratory fistulas - to date.
Most of the patients diagnosed with esophageal cancer are in a final stage of the disease and surgical morbidity and mortality are high, and 5 year survival very poor. Aim of the study was to compare three different palliative endoscopic treatments for patients that were not surgical candidates. In a 18 month period, 36 patients were diagnosed as having esophageal cancer at our unit. Twenty four were excluded from the study because very proximal or distal tumor, presence of tracheoesophageal fistula or the patient refused to participate in the study. The remaining 12 patients (1 adenocarcinoma and 11 squamous cell carcinoma) were randomized in 3 groups (4 patients in each group): Group I - alcohol injection, Group II - esophageal plastic stent and Group Ill - endoscopic gastrostomy. Nutritional data (weight, height, % fat, muscle weight) was recorded before treatment and during followup. Kamofsky index, disphagia score and subjective assessment of quality of life were also recorded. Patients were followed until they died (x=2.4 months, range 1-6 months). Only patients in Group III presented with improvement in nutritional status, although disphagia score improved in the other two groups (but anorexia developed in many patients). Complications (stent migration, perfuration and massive bleeding) were more common in Group II, and 2/4 patients in Group I developed tracheo,esophageal fistula. When we analyzed costs (using our reimbursement fees) alcohol injection was the most expensive treatment (g=-U$ 790.00),.compared to gastrostomy (i=U$ 475.00) and plastic stent (~=U$ 375.00). We concluded that gastrostomy is the best treatment to maintain nutritional status in patients with final stage esophageal cancer. Although plastic stent and alcohol injection are efficient in relieving disphagia, patients usually develop severe anorexia, and we could not detect any improvement in their quality of life.
?2o2 ?204
ENHANCED PDT EFFECT IN PATIENTS WITH ESOPHAGEAL CANCER BY LASER LIGHT FRACTIONATION - A PILOT STUDY. H~ Messmann, 1R.M. Szeimies, V. Gross, 1W. B~iumler, 2R. Knfichel, 3H Zimgibl, IM. Landthaler, J. SchSlmerich, A. Holstege. D e p a ~ of lmemal Medicine I, IDermatology, 2pathology and 3Surgery, University of Regensburg, Germany. In a recent study (Messmann et al., Br. J. Cancer.1995; 72: 589-594) we could enhance the PDT effect on normal rat colon after ALA induced photosen~itisation by laser light fractionation: In this pilot study we examined whether this modified laser treatment can also enhance the PDT effect in patients with esophageal cancer after sensitisation with hematoporphyrmes. Methods: 6 patients (4 early and 2 advanced carcinomas, one of these patients with tumor overgrowth of a metal stent) were treated in 9 sessions. In four : sessions laser energy was fractionated to enhance PDT effect using a new hematoperphyrm polyester, Photosan-3 TM (Seehof Laboratorien GmbH, Wesselburen, FRG). 48 hours after sensitisation with 2mg/kg i.v. Photosan-3 TM irradiation was performed with a cylinder diffuser at 630 nm using an argon pumped dye laser (2040 and 375b Spectra Physics L~sers Inc., Moontam View, Califorma, USA). The laser energy of 150J/cm was either applied continuously or fraetionated with a single break of 5 nfins after 75J/cm2 at 100mW. Results; In the group with continuous laser light irradiation there was a complete remission of 2 superficial esophageal cancers in one patient, while the third cancer did not respond. One patient with tumor overgrowth of a metal stent showed a si~nficant tmprovement of dysphagia without destruction of the stent, while in ataother patient with advanced esophageal cancer dysphagia did not improve after centmuous laser treatment. Fractionated laser therapy achieved a complete renussion in all 3 patients with early cancers, one of them did not respond to previous continuous PDT and a partial/'ennssion in a pattent with an uT2 cancer who showed also no rermssion aider continuous PDT However, in the group with fraetionated laser therapy two mild esophageal stenosis occured. Conclusion: Light fractionation during PDT seems to improve the PDT effect in our small number of patients, however, mild esophageal stenosis might be a problem. This modified treatment could be a promising therapy option to reduce the drug dose of HPD and also the side effect of prolonged skin sensitivity.
VOLUME 43, NO. 4, 1996
RECURRENCE RATE IN VARICEAL LIGATION THERAPY FOR ESOPHAGEAL VARICES COMPARED TO ENDOSCOPIC SCLEROTHERAPY: A PROSPECTIVE CONTROLLED TRIAL OF PROPHYLACTIC THERAPY FOR BLEEDING. T. Noda, Y. Gotoh, Y. Sakata, C. Matsunaga, S. Ogata, T. Koyama, H. Sakata, R. Iwakiri, and K. Fujimoto., Dept. of Intern. Med., Saga Med. School, Saga, JAPAN. Since endoscopic variceal ligation therapy (EVL) has been widespread i n treatment of esophageal varices (EV), both its advantage and disadvantage compared to endoscopic injection sclerotherapy (EIS) have attracted notice. To evaluate the efficacy of EVL, we performed a randomized prospective trail to compare the recurrence of EV treated by EVL to that of EIS in cirrhotic patients who underwent prophylactic therapy of EV. Methods. Fifty patients with severe cirrhosis, who were obtained informed consents to receive prophylactic therapy for bleeding of EV, were divided into two groups at random. Group I patients underwent sessions of EVL followed by one or two times EIS. Group II underwent EIS only during the therapeutic sessions. EVL session was performed with endoscopic ligation devices, and EIS session was performed with injection of 5% ethanolamine oleate. Follow-up endoscopic examination was performed 6, 12, and 16 months after the final session. Results. Table. Recurrence rate of EV after the final session.
EVL EIS
6 months
12 months
18 months
36.0%
44.0% * 12.0%
56.0% * 16.0%
8.0%
*
*=P<0.05, comparedto the EIS group. There were no differences in age, sex ratio, etiology of liver cirrhosis, or stage EV between two groups tested. In both groups, complete eradication of EV were achieved at the end of therapeutic sessions. As indicated in Table, the recurrence rate in the EVL group was significantly higher compared to the EIS groups at 6, 12 and 18 months after the final session. Conclusion. The present result showed that the recurrence rate was significantly higher in EVL, even combined with EIS, compared to EIS only. It indicates that EVL is less performed than EIS in regard to long-time efficacy of prophylactic therapy for bleeding of EV.
GASTROINTESTINAL ENDOSCOPY 341