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Endoscopic hemostasis of bleeding gastroduodenal ulcers: Fibrin sealant (Beriplast P) vs polidocanol 1%
STOMACH AND DUODENUM
$265
~267
ENDOSCOPIC HEMOSTASIS OF BLEEDING GASTRODUODENAL ULCERS: FIBRIN SEALANT (BERIPLAST| P) VS POLIDOCANOL 1% P. Rutger J, E. Rauws2, P. Wara 3, A. Hoes4 , E Sollcder on behalf of the Beriplast study team n, ~Dept. of Gastroenterology, Katholiekc Universiteit Leuvcn, B-3000 Leuven, 2Dept. of Gastroenterology. Acad Meal Center, NL1105 AZ Amsterdam, 3Surgical-Gastroentemlogical Dept. Kommunehospital, DK-8000 Arhus, *Behring-lnstitute (now Ccnteon Phatma), D-35001 Marburg.
GASTROINTESTINAL BLEEDING IN HOSPITALIZED PATIENTS ON ANTICOAGULATION : ROLE OF DIAGNOSTIC WORKUP. M Saxen~ S Gillin, Department of Medicine, Overlook Hospital, Summit N.J. and Columbia University College of Physicians and Surgeons.
From July 92 to Novvmber 95 a prospective, randomized, stratified, open and controlled study was performed in 19 centres m 9 European countries. A total of 942 patients (90 pilot study patients/g52 main study patients) were enrolled. Patients suffering from an eudoscopically verified gastroduodenal ulcer bleeding (spurting/oozing/visible vessel, [Forrest In, Ib, lla]) were randomly allocated to receive either single sclcrotherapy with polidoeanol or single injection therapy with fibrin sealant (FS) or repeated therapy with FS. A daily endoscopic control was performed until the ulcer ground was hematin covered or clean [Forrest llc or III]. A minimum inpatient observation period of 5 days and a safety follow up of one month were required. Primary" efficacy criterion was the rebleeding rate after complete initial hemostasis. Rebleeding was defined as visually (endoscopically/OP) verified bleeding from the same source. Moreover, safety of all three treatment groups were investigated. A planned interim analysis was performed after enrolment of 423 evaluable main study patients. It revealed that the proportion of initial hemostasis was higher than 97.5% in all strata and treatment groups. The overall incidences of reblecxting among the treatment groups were lowest for repeated FS application followed by single FS treatment~ the highest incidences were found for polidocanol. Safety analysis as well as evah~ation of laborato~ parameters and clinical variables revealed no specific risk for either treatment group. The final results including a detailed statistical analysis will be available in spring 96. HSteerirtg Comrmtee & J. Halttunen (SF-Helsinki), G. Dobrilla (l-Bolzano), G. Richter (D-Augsburg), R. Prassler (D-Minden), C. Soederlund (S-Stoeldlolm), A. Saggioro (l-Mestre), M. Matikainen (SF-Tampere), J. Kjaeve (N-Tromsoe), M. Osnes (N-Oslo), P. Swain (GB-London), L. Backman (S-Danderyd), G Fullarton (GB-Glasgow), S. Barstad (N-StavangerL A. Rosseland (NNordbyhagen), T. Sanerbruch (D-Bonn), U. Schentke (D-Dresden), M Praus (D-Marburg).
Purpose:(l) To estimate the risk of gastrointestinal bleeding in hospitalized patients on anticoagulation. (2)To study the yield of diagnostic workup and to identify the types of lesions responsible for the bleeding. Methods: A retrospective study of all hospitalized patients on coumadin and / or I.V. heparin, who received blood transfusions over a one year period was done. Patients with gastrointestinal bleeding were identified and the diagnostic workup was reviewed. We then did a comparative analysis of the types of lesions causing the bleeding. Results: The number of hospitalized patients on anticoagulants was 2893, of whom 393 received blood transfusions. 47 patients or 1.6% had a gastrointestinal bleeding as defined by malena hematemesis, hematoehezia, positive haemoccult and microeytic indices. No correlation was seen between the severity of bleeding and the degree of anticoagulation. No mortality was associated with the bleeding. 38 patients (81%) had upper, and 4 patients (8.5%) had lower gastrointestinal bleeding. 6 patients (12%) had a presumed gastrointestinal source of bleeding on account of microcytic hypochromie anemia. 36 of the 47 patients had an endoscopic workup and a cause of bleeding was found in 34 patients (94%). The most common cause was peptic ulcer disease found in 12 patients (33%). Gastritis was found in 8 patients(22%) and diverticula in 7 patients (19%). Other causes were AV malformations,malignant ulcer,hemorrhoids, esophagitis, angiodysplasias and intramural intestinal hemorrhage. No source of bleeding was found in 2. patients (5.6%). Conclusions: The risk of gastrointestinal bleeding in hospitalized patients on anticoagulation is low with no associated mortality. However we recommend that all patients who develop a gastrointestinal bleeding requiring blood transfusion should be investigated fully for the source of bleeding.
266
268
EARLY GASTRIC CANCER AFq'ER ENDOSCOPIC RESECTION A.SAISHO J.MATUMOTO J.YOSHIKAWA T.ARIMA The second Department of Internal Medicine, Faculty of Medicine, Kagoshima University, Kagoshima 890, JAPAN
TRANSENDOSCOPIC DILATION OF BENIGN GASTRIC OUTLET OBSTRUCTION, AN ALTERNATIVE TO SURGERY? R. Scheubel. K. Zenker, M. Wienbeck, Dept. of Medicine Ill, Zentralklinikum Augsburg, Germany.
Follow-up studies on patients with early gastric cancer after endoscopic resection (ER) was performed to evaluate efficacy of ER. ER procedure is as follows: Hypertonic saline solution containing epinephrine(3.7%NaCl 20ml + 0.1mg epinephiine) was injected into the lesion with pin-point marks. The elevated lesion was strangled with a snare wire after pulling the lesion with grasping forceps by using twochannel endoscope and then cut it off with high frequency current. ER procedure was performed for lesions less then 15ram in a diameter without ulcer and with natures of well-differentiated mucosal cancer determined and predicted by the histology and imaging studies including X-ray, endoscopy and endoscopic ultrasonography respectively. ER procedure was performed for 68 lesions of early gastric cancer from 64 patients in the past 8 years. In 42 lesions(62%) determined by histology to be complete resection, r.~ither residual cancer nor local recurrence has been detected during the average follow-up period of 33 months (3months - 72months). For 12 of the 26 lesions (38%) determined as incomplete resection by histology, surgical operations were performed and disclosed no residual cancer in the 7 lesions. One of the rest 5 lesions with residual cancer showed lymph node metastasis by the operation 12 months after the first ER procedure. For the 14 lesions with incompletely performed ER procedure and without operation ER procedure was repeated as well as Nd-YAG laser or cauterization with high frequency current. Thirteen of the 14 lesions were completely cured while the other one lesion is still receiving local immunotherapy with a staphylococcal preparation as the lesion developed to an inoperable advanced cancer. Finally the residual rate of cancerous tissue in total cases ha whom endoscopic therapies were performed was 8.8% ( 6 / 68). In conclusion, ER procedure for early gastric cancer is considered to be beneficial and closed follow-up studies for the patients am essential.
VOLUME 43, NO. 4, 1996
Introduction: Symptomatic gastric outlet obstruction clue to strictures used to be a clear indication for surgery. Aims: We set out to test the efficacy of endoscopic balloon dilation in benign gastric outlet stenoses. Methods: From 1993 to Oct. 1995 twenty-four consecutive patients (11 males, 13 females, 43 to 90 years old, median age 67) with severe symptoms due to gastric outlet stenosis underwent transendoscopic balloon dilation. Follow up time was 3 to 28 months (median 13). Fifty-one percent of all patients were helicobacter pylori positive. Results: The mean number of dilation procedures per patient was 3.2. Clinically sufficient improvement of symptoms was achieved in 10 of 13 patients with stricture and active ulcer (mean follow-up 13 months), in 2 of 2 with pyloric stricture (follow-up 15 months), in 4 of 6 patients with stenosis of gastrojejunal anastomosis with concomitant ulcer (mean follow-up 18 months) and in 2 of 3 patients with stricture after gastrojejunostomy. }n 60 endoscopies, with a total of 76 dilations, only one perforation occurred. The patient was successfully operated. 4 of 6 patients with unsuccessful dilation were finally operated upon and did well. Conclusion: Transendoscopic balloon dilation of benign symptomatic gastric outlet obstruction is a procedure with low risk that can be repeated and is successful in most situations. A prospective study comparing transendoscopic dilation with surgery is thus warranted.
GASTROINTESTINAL ENDOSCOPY
357
$265
~267
ENDOSCOPIC HEMOSTASIS OF BLEEDING GASTRODUODENAL ULCERS: FIBRIN SEALANT (BERIPLAST| P) VS POLIDOCANOL 1% P. Rutger J, E. Rauws2, P. Wara 3, A. Hoes4 , E Sollcder on behalf of the Beriplast study team n, ~Dept. of Gastroenterology, Katholiekc Universiteit Leuvcn, B-3000 Leuven, 2Dept. of Gastroenterology. Acad Meal Center, NL1105 AZ Amsterdam, 3Surgical-Gastroentemlogical Dept. Kommunehospital, DK-8000 Arhus, *Behring-lnstitute (now Ccnteon Phatma), D-35001 Marburg.
GASTROINTESTINAL BLEEDING IN HOSPITALIZED PATIENTS ON ANTICOAGULATION : ROLE OF DIAGNOSTIC WORKUP. M Saxen~ S Gillin, Department of Medicine, Overlook Hospital, Summit N.J. and Columbia University College of Physicians and Surgeons.
From July 92 to Novvmber 95 a prospective, randomized, stratified, open and controlled study was performed in 19 centres m 9 European countries. A total of 942 patients (90 pilot study patients/g52 main study patients) were enrolled. Patients suffering from an eudoscopically verified gastroduodenal ulcer bleeding (spurting/oozing/visible vessel, [Forrest In, Ib, lla]) were randomly allocated to receive either single sclcrotherapy with polidoeanol or single injection therapy with fibrin sealant (FS) or repeated therapy with FS. A daily endoscopic control was performed until the ulcer ground was hematin covered or clean [Forrest llc or III]. A minimum inpatient observation period of 5 days and a safety follow up of one month were required. Primary" efficacy criterion was the rebleeding rate after complete initial hemostasis. Rebleeding was defined as visually (endoscopically/OP) verified bleeding from the same source. Moreover, safety of all three treatment groups were investigated. A planned interim analysis was performed after enrolment of 423 evaluable main study patients. It revealed that the proportion of initial hemostasis was higher than 97.5% in all strata and treatment groups. The overall incidences of reblecxting among the treatment groups were lowest for repeated FS application followed by single FS treatment~ the highest incidences were found for polidocanol. Safety analysis as well as evah~ation of laborato~ parameters and clinical variables revealed no specific risk for either treatment group. The final results including a detailed statistical analysis will be available in spring 96. HSteerirtg Comrmtee & J. Halttunen (SF-Helsinki), G. Dobrilla (l-Bolzano), G. Richter (D-Augsburg), R. Prassler (D-Minden), C. Soederlund (S-Stoeldlolm), A. Saggioro (l-Mestre), M. Matikainen (SF-Tampere), J. Kjaeve (N-Tromsoe), M. Osnes (N-Oslo), P. Swain (GB-London), L. Backman (S-Danderyd), G Fullarton (GB-Glasgow), S. Barstad (N-StavangerL A. Rosseland (NNordbyhagen), T. Sanerbruch (D-Bonn), U. Schentke (D-Dresden), M Praus (D-Marburg).
Purpose:(l) To estimate the risk of gastrointestinal bleeding in hospitalized patients on anticoagulation. (2)To study the yield of diagnostic workup and to identify the types of lesions responsible for the bleeding. Methods: A retrospective study of all hospitalized patients on coumadin and / or I.V. heparin, who received blood transfusions over a one year period was done. Patients with gastrointestinal bleeding were identified and the diagnostic workup was reviewed. We then did a comparative analysis of the types of lesions causing the bleeding. Results: The number of hospitalized patients on anticoagulants was 2893, of whom 393 received blood transfusions. 47 patients or 1.6% had a gastrointestinal bleeding as defined by malena hematemesis, hematoehezia, positive haemoccult and microeytic indices. No correlation was seen between the severity of bleeding and the degree of anticoagulation. No mortality was associated with the bleeding. 38 patients (81%) had upper, and 4 patients (8.5%) had lower gastrointestinal bleeding. 6 patients (12%) had a presumed gastrointestinal source of bleeding on account of microcytic hypochromie anemia. 36 of the 47 patients had an endoscopic workup and a cause of bleeding was found in 34 patients (94%). The most common cause was peptic ulcer disease found in 12 patients (33%). Gastritis was found in 8 patients(22%) and diverticula in 7 patients (19%). Other causes were AV malformations,malignant ulcer,hemorrhoids, esophagitis, angiodysplasias and intramural intestinal hemorrhage. No source of bleeding was found in 2. patients (5.6%). Conclusions: The risk of gastrointestinal bleeding in hospitalized patients on anticoagulation is low with no associated mortality. However we recommend that all patients who develop a gastrointestinal bleeding requiring blood transfusion should be investigated fully for the source of bleeding.
266
268
EARLY GASTRIC CANCER AFq'ER ENDOSCOPIC RESECTION A.SAISHO J.MATUMOTO J.YOSHIKAWA T.ARIMA The second Department of Internal Medicine, Faculty of Medicine, Kagoshima University, Kagoshima 890, JAPAN
TRANSENDOSCOPIC DILATION OF BENIGN GASTRIC OUTLET OBSTRUCTION, AN ALTERNATIVE TO SURGERY? R. Scheubel. K. Zenker, M. Wienbeck, Dept. of Medicine Ill, Zentralklinikum Augsburg, Germany.
Follow-up studies on patients with early gastric cancer after endoscopic resection (ER) was performed to evaluate efficacy of ER. ER procedure is as follows: Hypertonic saline solution containing epinephrine(3.7%NaCl 20ml + 0.1mg epinephiine) was injected into the lesion with pin-point marks. The elevated lesion was strangled with a snare wire after pulling the lesion with grasping forceps by using twochannel endoscope and then cut it off with high frequency current. ER procedure was performed for lesions less then 15ram in a diameter without ulcer and with natures of well-differentiated mucosal cancer determined and predicted by the histology and imaging studies including X-ray, endoscopy and endoscopic ultrasonography respectively. ER procedure was performed for 68 lesions of early gastric cancer from 64 patients in the past 8 years. In 42 lesions(62%) determined by histology to be complete resection, r.~ither residual cancer nor local recurrence has been detected during the average follow-up period of 33 months (3months - 72months). For 12 of the 26 lesions (38%) determined as incomplete resection by histology, surgical operations were performed and disclosed no residual cancer in the 7 lesions. One of the rest 5 lesions with residual cancer showed lymph node metastasis by the operation 12 months after the first ER procedure. For the 14 lesions with incompletely performed ER procedure and without operation ER procedure was repeated as well as Nd-YAG laser or cauterization with high frequency current. Thirteen of the 14 lesions were completely cured while the other one lesion is still receiving local immunotherapy with a staphylococcal preparation as the lesion developed to an inoperable advanced cancer. Finally the residual rate of cancerous tissue in total cases ha whom endoscopic therapies were performed was 8.8% ( 6 / 68). In conclusion, ER procedure for early gastric cancer is considered to be beneficial and closed follow-up studies for the patients am essential.
VOLUME 43, NO. 4, 1996
Introduction: Symptomatic gastric outlet obstruction clue to strictures used to be a clear indication for surgery. Aims: We set out to test the efficacy of endoscopic balloon dilation in benign gastric outlet stenoses. Methods: From 1993 to Oct. 1995 twenty-four consecutive patients (11 males, 13 females, 43 to 90 years old, median age 67) with severe symptoms due to gastric outlet stenosis underwent transendoscopic balloon dilation. Follow up time was 3 to 28 months (median 13). Fifty-one percent of all patients were helicobacter pylori positive. Results: The mean number of dilation procedures per patient was 3.2. Clinically sufficient improvement of symptoms was achieved in 10 of 13 patients with stricture and active ulcer (mean follow-up 13 months), in 2 of 2 with pyloric stricture (follow-up 15 months), in 4 of 6 patients with stenosis of gastrojejunal anastomosis with concomitant ulcer (mean follow-up 18 months) and in 2 of 3 patients with stricture after gastrojejunostomy. }n 60 endoscopies, with a total of 76 dilations, only one perforation occurred. The patient was successfully operated. 4 of 6 patients with unsuccessful dilation were finally operated upon and did well. Conclusion: Transendoscopic balloon dilation of benign symptomatic gastric outlet obstruction is a procedure with low risk that can be repeated and is successful in most situations. A prospective study comparing transendoscopic dilation with surgery is thus warranted.
GASTROINTESTINAL ENDOSCOPY
357