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Randomised controlled trial of ligation, clips, stitching, and injection sclerotherapy in a model of variceal bleeding
ESOPHAGUS t213
#215
ENDOSONOGRAPHIC T-STAGING OF ESOPHAGEAL CARCINOMA: A LEARNING CURVE. P.Fockens, J.H.M.Vandenbrande, H.M.van Dullemen, J.J.B.van Lanscliot*, G.N.J.Tytgat Depts of Gastroenterology and Surgery*, Academic Medical Center, University of Amsterdam, Meibergdrenf 9, 1105 AZ Amsterdam, the Netherlands The number of endosonographic (ES) examinations necessary to become accurate in staging of esophageal carcinoma is unclear. It has been suggested that at least 50 exams are necessary. Methods: Since 7/91 all esophageal ES-exams were performed by one endoscopist in our institution, who had just finished a hands-on training period of eight weeks. All ES exams were coded for indication and prospectively entered in a database. From 7/91 till 4/93, 231 ES exams were performed for diagnosis, staging or follow-up of esophageal malignancies. Of the group that were referred for pre-operative staging, adequate follow-up could be collected in 89 patients who underwent surgery. Seventy-one patients were resectable. Of these patients pathological T-staging was compared to preoperative T-staging by ES. Results: ES T-staging was correct in 50/71 pts (70%). In 10 cases ES overstaged the tumor, in 11 cases ES understaged. The pts were then split in 2 groups. Group I consisted of 36 pts examined between 7/91 and 4/92. In this period a total of 100 ES exams were performed for esophageal malignancies. Group II consisted 0f35 pts examined between 4/92 and 3/93. In this period 131 ES exams were performed for esophageal malignancies. The accuracy ofT-staging in group i was 58%, in group II 83% (t)<0.05). Within group I there was no significant difference in the accuracy of staging in the first 50 pts (62%) compared to that in the second 50 pts (50%). The percentage overstaged was equal in groups I & II (14%). Understaging was common in group I (28%), but happened in only one patient in group 11 (3%).Conchision: This study shows that there is a clear learning curve for T-staging of esophageal carcinoma. Accuracy rates comparable to the literature could only be achieved after 100 patients had been examined. From these data we recommend performance of at least 100 exams before accreditation.
A NOVEL METHOD FOR OVERTUBE PLACEMENT IN ENDOSCOPIC VARICEAL LIGATION. CJ Han, HC Jung, H-S Lee, YB Yoon, IS Song, KW Choi, CY Kim. Department of lnmrnal Medicine, Seoul National University, College of Medicine, Seoul, Korea. Background. Endoscopic variceal ligation (EVL) is effective for the management of bleeding esophageal varices, and its use is widespread now. EVL necessitates the use of overtubes. Two primary techniques have been used for overtube placement; one is with endoscope, and the other is with bougie dilator. Overtube placement with endoscope is not without risk. There are reports of esophageal or pharyngeal laceration or perforation. Overtube placement with bougie dilator circumvents this risk, but it is rather cumbersome to use. The authors devised a safe and easy method for overtube placement, and applied it to a number of patients to test its safety and convenience. Method. First, overtube-dilator assembly was prepared as follows. A RigiflexTM achalasia dilator (balloon 30 mm OD, 10 cm length; Microvasive Co) was lubricated and inserted into the overtube. A tenth of the balloon tip was protruded out of the overtube, then the balloon was insufflated with air at 10-15 psi. Second, standard endoscopy was performed, followed by placement of guide-wire in the stomach. Overtube-dilator assembly was lubricated and introduced over the wire as a rail. Once the overtube was properly positioned, the balloon was deflated, and the balloon and wire were removed as a whole, which completed overtube placement. Results. For 65 patients with esophageal variceal bleeding, 8 2 procedures of EVL were performed using the new technique. Overtube-dilator assembly was easy to prepare and handle. This technique added little time to the procedure and minimizes patient discomfort. No patient suffered major complications such as bleeding, laceration or perforation. Conclusion. This novel method for overtube placement was safe and convenient for use in EVL. It can also be applied to other procedures using overtube such as endoscopic foreign body removal.
t214
t216
E N D O S C O P I C U L T R A S O U N D (EUS) S T A G I N G IN PATIENTS (PTS~ WITH ESOPHAGEAL CANCER (ECa) IS MORE A C C U R A T E THAN CT AND CORRELATES W I T H SURVIVAL. F. Gress, S. Ikenberry, D. C o n c e s , J. Wonn, Q. Khruso, R. Hawes. D i v i s i o n of Gastroenterology, Indiana U n i v e r s i t y Medical Center, Indianapolis, IN. I N T R O D U C T I O N : EUS provides the most accurate local staging of ECa but it has not been shown that more accurate staging improves pt. outcome. A I M OF STUDY: To r e v i e w our accuracy in staging ECa w i t h EUS and CT and to c o r r e l a t e p r e o p e r a t i v e EUS stage with outcome m e a s u r e d by gross survival in both operated and n o n - o p e r a t e d pts. ~ T H O D S : Data was analyzed for 94 consecutive pts. b e t w e e n 6/91 - 10/94. Local staging w a s c l a s s i f i e d by the T N M system. 40 pts (43%) went to surgery. In 95% (38/40) local T & N staging i n f o r m a t i o n was available. survival data was available for all 94 pts. EUS and CT staging accuracy, m e d i a n survival time and K a p l a n - M e i e r curves were compared b e t w e e n the o p e r a t e d and n o n - o p e r a t e d groups. RESULTS| 94 pts. (81M/13F) with a m e a n age of 63 y r s . ( r a n g e = 37-86} were studied. 62% (58/94 pts.) w e r e adeno CA while 38% (36/94 pts.) were squamous CA. Pts. w e r e divided into 2 groups: group i (N=40, m e a n age 60) went to surgery (§ preop adjuvant therapy). G r o u p 2 (N=54, m e a n age 67} were medically treated (any of the following: chemo/RT, laser, dilation, or stenting). G r o u p 1 pts. had a high p e r c e n t a g e of GEJ tumors and adeno CA. Group 2 pts. w e r e noted to have more proximal tumors and squamous CA. OVERALL EUS STAGING ACCURACY: T STAGE N STAGE
RANDOMISED C O N T R O L L E D T R I A L OF L I G A T I O N , CLIPS, STITCHING, AND INJECTION SCLEROTHERAPY IN A M O D E L O F VARICEAL B L E E D I N G . C . C . H e n w o r t h , S.S.Kadirkamanathan, F.Gong, C.P.Swain. GI Science Research Unit, Whitechapel, London UK. There is increasing interest in mechanical methods of variceal hemostasis. We compared injection sclerotherapy with mechanical methods in an experimental model. Canine mesenteric veins of 1-5mm diameter were selected because they are of a size comparable to those seen in human esophageal varices. The veins were injected or mechanically occluded at two points and the effectiveness of hemostasis tested by cutting between the two points. Injection method consisted of ethanolamine. Mechanical methods studied were a)Olympus clip fixing device HX-3 and clips, b) Bard, Stiegman Goff band ligator, c) Sewing machine, d) Olympus HX-20 ligating device (self retaining snare). RESULTS 1) Injection failed to stop bleeding from lmm (n=20), and 2ram (n=20) vessels. 2) Olympus MD59 clips failed to stop bleeding from lmm vessels (in 17 out of 20 cases), 2mm (in 18 out of 20 cases), and 3mm vessels (n=20). 3) Olympus MD850 clips failed on lmm (n=15), 2mm (n=15) and 3mm (n=10) vessels. 4) Olympus prototype clip (larger than the others) failed on lmm (n=5), 2mm (n=5) and 3mm (n=5). Extra pressure applied to the clips stopped bleeding suggesting modification may improve results. 5)Prestretched bands failed on lmm vessels (n=5), however unstretched bands stopped bleeding from 2mm vessels (n=15) but failed with 3ram vessels in 7 out of 10 cases). 6) Sewing machine succeeded on 4mm (n=10) but failed on 5rnm vessels (n=5). 7) Olympus HX-20 ligating device succeeded on both 3mm (n=5), 4mm (n=5) and 5mm (n=5) as well as securing hemostasis on a 12 mm diameter splenic artery and vein (n=l). CONCLUSION Injection sclerotherapy was ineffective in stopping acute bleeding from any veins in this model. Mechanical models b),c) and d) were effective on small veins and were significantly (p<0.05) more effective in stopping bleeding than injection. However the clips need modifying and pre-stretched bands are less effective than unstretched bands.
EUS 1 CT
84' 20%
1
8i' 28%
I
SURVIVAL= --MedianSurvival(months)
Surgery T-1 T-2 T-3 T-4 NO N1
1 9 . 2 (n = 7) 1 0 . 5 (n = 10) 8 . 5 (n = 17) 8 . 2 (n = 4) 1 6 . 0 (n = 12) 8 . 9 (n = 2 5 )
Medical 10.1 (n = 7) 1 0 . 5 (n = 2 3 ) 1 0 . 2 (n = 2 4 ) 1 4 . 7 (n = 3) 9 . 2 (n = 5 1 )
SUMMARY: Our data for EUS staging a c c u r a c y and comparison to CT data was similar to previous reports. EUS staging of ECa correlates w i t h survival: I) T t survival >T2, T) 2) N e survival >N 1 3) when N 0 was compared b e t w e e n both groups, group 1 survivedlonger, but w h e n T 1 pts. were e x c l u d e d this was no longer significant 4) T 1 tumors benefit from surgery while T2, T 3 and NI do not. CONCLUSIONS= This study supports the routine u s e of EUS in staging ECa and p r e d i c t i n g survival. EUS can direct treatment because it a c c u r a t e l y stages the tumor, the EUS stage correlates with survival and surgery provides no survival benefit for pts. w i t h T2, T 3 and N I disease.
V O L U M E 41, NO. 4, 1995
GASTROINTESTINAL ENDOSCOPY
349
#215
ENDOSONOGRAPHIC T-STAGING OF ESOPHAGEAL CARCINOMA: A LEARNING CURVE. P.Fockens, J.H.M.Vandenbrande, H.M.van Dullemen, J.J.B.van Lanscliot*, G.N.J.Tytgat Depts of Gastroenterology and Surgery*, Academic Medical Center, University of Amsterdam, Meibergdrenf 9, 1105 AZ Amsterdam, the Netherlands The number of endosonographic (ES) examinations necessary to become accurate in staging of esophageal carcinoma is unclear. It has been suggested that at least 50 exams are necessary. Methods: Since 7/91 all esophageal ES-exams were performed by one endoscopist in our institution, who had just finished a hands-on training period of eight weeks. All ES exams were coded for indication and prospectively entered in a database. From 7/91 till 4/93, 231 ES exams were performed for diagnosis, staging or follow-up of esophageal malignancies. Of the group that were referred for pre-operative staging, adequate follow-up could be collected in 89 patients who underwent surgery. Seventy-one patients were resectable. Of these patients pathological T-staging was compared to preoperative T-staging by ES. Results: ES T-staging was correct in 50/71 pts (70%). In 10 cases ES overstaged the tumor, in 11 cases ES understaged. The pts were then split in 2 groups. Group I consisted of 36 pts examined between 7/91 and 4/92. In this period a total of 100 ES exams were performed for esophageal malignancies. Group II consisted 0f35 pts examined between 4/92 and 3/93. In this period 131 ES exams were performed for esophageal malignancies. The accuracy ofT-staging in group i was 58%, in group II 83% (t)<0.05). Within group I there was no significant difference in the accuracy of staging in the first 50 pts (62%) compared to that in the second 50 pts (50%). The percentage overstaged was equal in groups I & II (14%). Understaging was common in group I (28%), but happened in only one patient in group 11 (3%).Conchision: This study shows that there is a clear learning curve for T-staging of esophageal carcinoma. Accuracy rates comparable to the literature could only be achieved after 100 patients had been examined. From these data we recommend performance of at least 100 exams before accreditation.
A NOVEL METHOD FOR OVERTUBE PLACEMENT IN ENDOSCOPIC VARICEAL LIGATION. CJ Han, HC Jung, H-S Lee, YB Yoon, IS Song, KW Choi, CY Kim. Department of lnmrnal Medicine, Seoul National University, College of Medicine, Seoul, Korea. Background. Endoscopic variceal ligation (EVL) is effective for the management of bleeding esophageal varices, and its use is widespread now. EVL necessitates the use of overtubes. Two primary techniques have been used for overtube placement; one is with endoscope, and the other is with bougie dilator. Overtube placement with endoscope is not without risk. There are reports of esophageal or pharyngeal laceration or perforation. Overtube placement with bougie dilator circumvents this risk, but it is rather cumbersome to use. The authors devised a safe and easy method for overtube placement, and applied it to a number of patients to test its safety and convenience. Method. First, overtube-dilator assembly was prepared as follows. A RigiflexTM achalasia dilator (balloon 30 mm OD, 10 cm length; Microvasive Co) was lubricated and inserted into the overtube. A tenth of the balloon tip was protruded out of the overtube, then the balloon was insufflated with air at 10-15 psi. Second, standard endoscopy was performed, followed by placement of guide-wire in the stomach. Overtube-dilator assembly was lubricated and introduced over the wire as a rail. Once the overtube was properly positioned, the balloon was deflated, and the balloon and wire were removed as a whole, which completed overtube placement. Results. For 65 patients with esophageal variceal bleeding, 8 2 procedures of EVL were performed using the new technique. Overtube-dilator assembly was easy to prepare and handle. This technique added little time to the procedure and minimizes patient discomfort. No patient suffered major complications such as bleeding, laceration or perforation. Conclusion. This novel method for overtube placement was safe and convenient for use in EVL. It can also be applied to other procedures using overtube such as endoscopic foreign body removal.
t214
t216
E N D O S C O P I C U L T R A S O U N D (EUS) S T A G I N G IN PATIENTS (PTS~ WITH ESOPHAGEAL CANCER (ECa) IS MORE A C C U R A T E THAN CT AND CORRELATES W I T H SURVIVAL. F. Gress, S. Ikenberry, D. C o n c e s , J. Wonn, Q. Khruso, R. Hawes. D i v i s i o n of Gastroenterology, Indiana U n i v e r s i t y Medical Center, Indianapolis, IN. I N T R O D U C T I O N : EUS provides the most accurate local staging of ECa but it has not been shown that more accurate staging improves pt. outcome. A I M OF STUDY: To r e v i e w our accuracy in staging ECa w i t h EUS and CT and to c o r r e l a t e p r e o p e r a t i v e EUS stage with outcome m e a s u r e d by gross survival in both operated and n o n - o p e r a t e d pts. ~ T H O D S : Data was analyzed for 94 consecutive pts. b e t w e e n 6/91 - 10/94. Local staging w a s c l a s s i f i e d by the T N M system. 40 pts (43%) went to surgery. In 95% (38/40) local T & N staging i n f o r m a t i o n was available. survival data was available for all 94 pts. EUS and CT staging accuracy, m e d i a n survival time and K a p l a n - M e i e r curves were compared b e t w e e n the o p e r a t e d and n o n - o p e r a t e d groups. RESULTS| 94 pts. (81M/13F) with a m e a n age of 63 y r s . ( r a n g e = 37-86} were studied. 62% (58/94 pts.) w e r e adeno CA while 38% (36/94 pts.) were squamous CA. Pts. w e r e divided into 2 groups: group i (N=40, m e a n age 60) went to surgery (§ preop adjuvant therapy). G r o u p 2 (N=54, m e a n age 67} were medically treated (any of the following: chemo/RT, laser, dilation, or stenting). G r o u p 1 pts. had a high p e r c e n t a g e of GEJ tumors and adeno CA. Group 2 pts. w e r e noted to have more proximal tumors and squamous CA. OVERALL EUS STAGING ACCURACY: T STAGE N STAGE
RANDOMISED C O N T R O L L E D T R I A L OF L I G A T I O N , CLIPS, STITCHING, AND INJECTION SCLEROTHERAPY IN A M O D E L O F VARICEAL B L E E D I N G . C . C . H e n w o r t h , S.S.Kadirkamanathan, F.Gong, C.P.Swain. GI Science Research Unit, Whitechapel, London UK. There is increasing interest in mechanical methods of variceal hemostasis. We compared injection sclerotherapy with mechanical methods in an experimental model. Canine mesenteric veins of 1-5mm diameter were selected because they are of a size comparable to those seen in human esophageal varices. The veins were injected or mechanically occluded at two points and the effectiveness of hemostasis tested by cutting between the two points. Injection method consisted of ethanolamine. Mechanical methods studied were a)Olympus clip fixing device HX-3 and clips, b) Bard, Stiegman Goff band ligator, c) Sewing machine, d) Olympus HX-20 ligating device (self retaining snare). RESULTS 1) Injection failed to stop bleeding from lmm (n=20), and 2ram (n=20) vessels. 2) Olympus MD59 clips failed to stop bleeding from lmm vessels (in 17 out of 20 cases), 2mm (in 18 out of 20 cases), and 3mm vessels (n=20). 3) Olympus MD850 clips failed on lmm (n=15), 2mm (n=15) and 3mm (n=10) vessels. 4) Olympus prototype clip (larger than the others) failed on lmm (n=5), 2mm (n=5) and 3mm (n=5). Extra pressure applied to the clips stopped bleeding suggesting modification may improve results. 5)Prestretched bands failed on lmm vessels (n=5), however unstretched bands stopped bleeding from 2mm vessels (n=15) but failed with 3ram vessels in 7 out of 10 cases). 6) Sewing machine succeeded on 4mm (n=10) but failed on 5rnm vessels (n=5). 7) Olympus HX-20 ligating device succeeded on both 3mm (n=5), 4mm (n=5) and 5mm (n=5) as well as securing hemostasis on a 12 mm diameter splenic artery and vein (n=l). CONCLUSION Injection sclerotherapy was ineffective in stopping acute bleeding from any veins in this model. Mechanical models b),c) and d) were effective on small veins and were significantly (p<0.05) more effective in stopping bleeding than injection. However the clips need modifying and pre-stretched bands are less effective than unstretched bands.
EUS 1 CT
84' 20%
1
8i' 28%
I
SURVIVAL= --MedianSurvival(months)
Surgery T-1 T-2 T-3 T-4 NO N1
1 9 . 2 (n = 7) 1 0 . 5 (n = 10) 8 . 5 (n = 17) 8 . 2 (n = 4) 1 6 . 0 (n = 12) 8 . 9 (n = 2 5 )
Medical 10.1 (n = 7) 1 0 . 5 (n = 2 3 ) 1 0 . 2 (n = 2 4 ) 1 4 . 7 (n = 3) 9 . 2 (n = 5 1 )
SUMMARY: Our data for EUS staging a c c u r a c y and comparison to CT data was similar to previous reports. EUS staging of ECa correlates w i t h survival: I) T t survival >T2, T) 2) N e survival >N 1 3) when N 0 was compared b e t w e e n both groups, group 1 survivedlonger, but w h e n T 1 pts. were e x c l u d e d this was no longer significant 4) T 1 tumors benefit from surgery while T2, T 3 and NI do not. CONCLUSIONS= This study supports the routine u s e of EUS in staging ECa and p r e d i c t i n g survival. EUS can direct treatment because it a c c u r a t e l y stages the tumor, the EUS stage correlates with survival and surgery provides no survival benefit for pts. w i t h T2, T 3 and N I disease.
V O L U M E 41, NO. 4, 1995
GASTROINTESTINAL ENDOSCOPY
349