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Clinical outcomes of Endoscopic Ultrasound (EUS): The American Endosonography Club study
ENDOSCOPIC TECHNOLOGY 57
$59
INITIAL EXPERIENCE WITH THE "MAX FORCE" THROUGH THE SCOPE ESOPHAGEAL BALLOON J. Nash. A.L. Attia anti R.S. McCray, Department of Medicine, St. Luke'sRoosevelt Hospital Center, New York, N.Y.
CL1NICAL OUTCOMES OF ENDOSCOPIC ULTRASOUND (EUS): THE AMERICAN ENDOSONOGRAPHY CLUB STUDY N Nickl, B Hoffman, R Hawes, M Bhutani, M Catalano, J Affronti, L Roubein, M Kimmey, A Chak, M Johnson, W Boyce, M Canto, M Sivak, C Lightdale, P Stevens. American Endosonography Club, USA Data regarding clinical impact and complications of EUS in routine patient care are lacking. 13 experienced endosonographers at 10 US centers prospectively evaluated consecutive EUS exams by each endosonographer. To assess the impact of EUS on clinical outcomes, endosonographers were asked before each EUS to document further theoretical management for the patient if EUS were unavailable including both diagnostic (testing) and therapeutic (treatment) plans. After EUS, endosonographers indicated actual management plans based on EUS results. Complications were prospectively stratified by severity, and assessed both after the EUS and in short term follow-up. RESULTS: 308 subjects were enrolled. Examination was successful in 99% of cases (partial success in 7%) and failed in 1%. EUS results changed the management plan in 74% of cases (95% confidence interval [CI] for management change = 69-79%). Management changes of major impact (e.g. surgical vs. non-surgical care, etc.) occurred in 29% of subjects. The change in management was to less cosily, risky, or invasive management in 56%, to more cosfly/risky/invasivein 34%, and to equally costly/risky/invasivein 10%. The table shows theoretical (pre-EUS) and actual (post;EUS) management plans for th group. t Further Tests Further Treatment none non-invas invasive none non-surg surgical
Since 1981, we have routinely used the "Rigiflex", through the scope balloons (TTS) as primary dilating devices, as they are used without a wire or fluoroscopy and are theoretically safer as their force is "lateral". There have been malignant strictures that have required either metal (Eder-Puestow) or Polyvinyl (Savary or KAD) dilators, as the original Rigiflex TI'S balloons were not "strong" enough to obtain sufficient dilation. The "Max Force TTS" balloon, which became available in August 1994, is made of a "high pressure, abrasion-resistant, Triax balloon material." It is designed to pass more easily through the endoscope and to provide "stronger~ lateral force. Ten patients with esophageal strictures, 8 of which were malignant, were dilated with 15ram balloons. Treatment success was defined as the ability to pass a therapeutic l l m m endoscope beyond the stricture. Two malignant strictures were dilated with Max Force after Rigiflex failures. In the other 8, treatment was initiated with Max Force. Overall, 17 of 21 Max Force dilations were successful. Max Force failures occurred in two patients with very proximal malignant strictures which could not be adequately visualized with the balloon in place. These were subsequently dilated with polyvinyl dilators. Max Force was found to pass much more easily than Rigiflex. This initial experience suggests that Max Force is superior to Rigiflex. However, because Max Force is not reusable, we reserve it for strictures that may not be dilated with Rigiflex. It remains to be determined whether fewer dilations will be required with the Max Force. Studies are also needed to compare Max Force with metal or polyvinyl dilators.
25%
26%
49%
2%
55%
43%
46% 14% 39% 7% 54% 39% Regarding complications, short term follow-up was completed in 232 (75%) subjects, with 4 complications identified (1.7%), The 95% CI for complications was 0-3.4%; 2 complications were mild (transient sore throat; 02 desaturation during EUS) and 2 were moderate (abdominal pain with 1-2 day hospitalization for observation). All resolved without specific treatment. There were no major or fatal complications (95% CI < 1.3%). CONCLUSIONS: (1) Changes in management plan are made in the majority of patients based on EUS results. (2) The management changes are often of major importance with regard to health care costs and safety, and are more often in the direction of less costly, risky, and invasive management. (3) EUS is safe in experienced hands.
t58
t60
Difficult Sigmoid Colon Intnbation-Guidewire Exchange Technique to Achieve Complete Colonoscopy R Ness, K Gottlieb, D Rex, G _Lehman. Indiana University Medical Center, Indianapolis, IN. Introduction: Previous reports have shown that small diameter UGI endoscopes and pediatric colonoscopes (CS) can be successfully employed to negotiate fixed sigmoid loops and/or strictures when these lesions prevent the passage of a larger-diameter, adult CS. Unfortunately, UGI endoscopes are often too short to reach the cecum, and pediatric CS are not available in many endoscopy units. Methods: Nineteen consecutive patients with non-neoplastic angulation/narrowing of the sigmoid coLon that prevented passage of an adult CS were restudied using an UGI endoscope (Olympus models GIF-100, 9.8 mm diameter; or GIFXP20, 7.9 mm diameter). Once the area of difficulty was traversed, the UGI endoscope was inserted to its f~ll length. Next, a guidewire (WilsonCook model SGW-360, 360 cm Savary wire or a combination of two Wilson-Cook model THSF-35400, 400 cm/0.035 inch diameter, ERCPtype wires) was passed through the endoscope and into the proximal colon. The endoscope was then withdrawn, Leaving the wire in place. Next, the extracorporeal wire was back-loaded into a standard, 13.4 mm diameter, adult CS using an opan-ended wash-catheter or the catheter portion of a polypectomy snare that had been advanced through the length of the biopsy channel. The catheter was then slowly withdrawn as the guidewire was proportionately advanced until it exited the biopsy port. Finally, the CS was advanced through the sigmoid and into the proximal colon with the use of minimal guidewire tension. Once the CS traversed the sigmoid colon, the guidewire was removed and the CS advanced to the cecum. Results: In each of the 19 cases, the sigmoid angulation/narrowing was traversed and cecal intubation achieved. In no case was the cecum reached with the UGI endoscope. There were no apparent complications other than very minor mucosal trauma due to guidewire passage. Summary: UGI endoscopes successfully traversed areas of sigmoid angulation/uarrowing, but were too short to reach the cecum. Guidewire exchange to a CS permitted the safe completion of colonoscopy with cecal intubation. Conclusion: This guidewire exchange technique appears safe and effective. It should be considered for general use in similar cases.
ACCURACY OF ENDOSCOPIC ULTRASOUND STAGING OF ESOPHAGEAL CARCINOMA AFTER SUCCESSFUL INDUCTION CHEMORADIOTHERAPY R.Pimentel, C~ 7a~ccaro, D.J. Adelstein, T.W. Rice; Cleveland Clinic, Cleveland, Ohio INTROI'311CTIf)N: The accuracy of endoseopie ultrasound (EUS) in pre-operative staging of esophageal carcinoma is well documented, with T stage accuracy and N stage sensitivity of 70-90%. Its ability to predict response to effective induction chemoradiotherapy is less established; an initial experience is presented. MF.TI-IOD.q: 34 patients (8 squamons cell, 26 adenocarcinoma) underwent combination chemotherapy with concurrent radiation therapy, followed by esophagectomy. Initial EUS was possible in 32/34 patients before induction chemoradiotherapy; in 2 patients with strictures no significant information could be obtained. EUS was done in all 34 patients post-induction, prior to surgery.
310
GASTROINTESTINAL ENDOSCOPY
Initial. EUS (n =32) Post-induction EUS (n=34) Esophagectomy/Pathology (n=34)
To
T~2
0 2 13
4 3 10
-T3---T, 28 29 ll(all "1"3)
Of the 13 T o patients at surgery, 1 was ToNt; the other 12/34 (35%) had no residual cancer. EUS predicted no residual cancer in only 1/12 (8%). Overall, the post-induction EUS T stage accuracy was 35%. With respect to N stage, 12 patients had malignant nodes (hit) at surgery/pathology. Initial EUS was positive for N~ in 11/12 cases (sensitivity 92%). Post-induction EUS was positive for N~ in only 5 of these 12 (sensitivity 42%). CONC! JISIORS: EUS does not accurately predict response to induction chemoradiotherapy. Assessment of depth of tumor invasion is limited by inability to distinguish viable tumor from fibrosis and inflammation. Established EUS criteria to distinguish malignant from reactive nodes (size, shape, border characteristics) may not apply after chemoradiotherapy.
VOLUME 41, NO. 4, 1995
$59
INITIAL EXPERIENCE WITH THE "MAX FORCE" THROUGH THE SCOPE ESOPHAGEAL BALLOON J. Nash. A.L. Attia anti R.S. McCray, Department of Medicine, St. Luke'sRoosevelt Hospital Center, New York, N.Y.
CL1NICAL OUTCOMES OF ENDOSCOPIC ULTRASOUND (EUS): THE AMERICAN ENDOSONOGRAPHY CLUB STUDY N Nickl, B Hoffman, R Hawes, M Bhutani, M Catalano, J Affronti, L Roubein, M Kimmey, A Chak, M Johnson, W Boyce, M Canto, M Sivak, C Lightdale, P Stevens. American Endosonography Club, USA Data regarding clinical impact and complications of EUS in routine patient care are lacking. 13 experienced endosonographers at 10 US centers prospectively evaluated consecutive EUS exams by each endosonographer. To assess the impact of EUS on clinical outcomes, endosonographers were asked before each EUS to document further theoretical management for the patient if EUS were unavailable including both diagnostic (testing) and therapeutic (treatment) plans. After EUS, endosonographers indicated actual management plans based on EUS results. Complications were prospectively stratified by severity, and assessed both after the EUS and in short term follow-up. RESULTS: 308 subjects were enrolled. Examination was successful in 99% of cases (partial success in 7%) and failed in 1%. EUS results changed the management plan in 74% of cases (95% confidence interval [CI] for management change = 69-79%). Management changes of major impact (e.g. surgical vs. non-surgical care, etc.) occurred in 29% of subjects. The change in management was to less cosily, risky, or invasive management in 56%, to more cosfly/risky/invasivein 34%, and to equally costly/risky/invasivein 10%. The table shows theoretical (pre-EUS) and actual (post;EUS) management plans for th group. t Further Tests Further Treatment none non-invas invasive none non-surg surgical
Since 1981, we have routinely used the "Rigiflex", through the scope balloons (TTS) as primary dilating devices, as they are used without a wire or fluoroscopy and are theoretically safer as their force is "lateral". There have been malignant strictures that have required either metal (Eder-Puestow) or Polyvinyl (Savary or KAD) dilators, as the original Rigiflex TI'S balloons were not "strong" enough to obtain sufficient dilation. The "Max Force TTS" balloon, which became available in August 1994, is made of a "high pressure, abrasion-resistant, Triax balloon material." It is designed to pass more easily through the endoscope and to provide "stronger~ lateral force. Ten patients with esophageal strictures, 8 of which were malignant, were dilated with 15ram balloons. Treatment success was defined as the ability to pass a therapeutic l l m m endoscope beyond the stricture. Two malignant strictures were dilated with Max Force after Rigiflex failures. In the other 8, treatment was initiated with Max Force. Overall, 17 of 21 Max Force dilations were successful. Max Force failures occurred in two patients with very proximal malignant strictures which could not be adequately visualized with the balloon in place. These were subsequently dilated with polyvinyl dilators. Max Force was found to pass much more easily than Rigiflex. This initial experience suggests that Max Force is superior to Rigiflex. However, because Max Force is not reusable, we reserve it for strictures that may not be dilated with Rigiflex. It remains to be determined whether fewer dilations will be required with the Max Force. Studies are also needed to compare Max Force with metal or polyvinyl dilators.
25%
26%
49%
2%
55%
43%
46% 14% 39% 7% 54% 39% Regarding complications, short term follow-up was completed in 232 (75%) subjects, with 4 complications identified (1.7%), The 95% CI for complications was 0-3.4%; 2 complications were mild (transient sore throat; 02 desaturation during EUS) and 2 were moderate (abdominal pain with 1-2 day hospitalization for observation). All resolved without specific treatment. There were no major or fatal complications (95% CI < 1.3%). CONCLUSIONS: (1) Changes in management plan are made in the majority of patients based on EUS results. (2) The management changes are often of major importance with regard to health care costs and safety, and are more often in the direction of less costly, risky, and invasive management. (3) EUS is safe in experienced hands.
t58
t60
Difficult Sigmoid Colon Intnbation-Guidewire Exchange Technique to Achieve Complete Colonoscopy R Ness, K Gottlieb, D Rex, G _Lehman. Indiana University Medical Center, Indianapolis, IN. Introduction: Previous reports have shown that small diameter UGI endoscopes and pediatric colonoscopes (CS) can be successfully employed to negotiate fixed sigmoid loops and/or strictures when these lesions prevent the passage of a larger-diameter, adult CS. Unfortunately, UGI endoscopes are often too short to reach the cecum, and pediatric CS are not available in many endoscopy units. Methods: Nineteen consecutive patients with non-neoplastic angulation/narrowing of the sigmoid coLon that prevented passage of an adult CS were restudied using an UGI endoscope (Olympus models GIF-100, 9.8 mm diameter; or GIFXP20, 7.9 mm diameter). Once the area of difficulty was traversed, the UGI endoscope was inserted to its f~ll length. Next, a guidewire (WilsonCook model SGW-360, 360 cm Savary wire or a combination of two Wilson-Cook model THSF-35400, 400 cm/0.035 inch diameter, ERCPtype wires) was passed through the endoscope and into the proximal colon. The endoscope was then withdrawn, Leaving the wire in place. Next, the extracorporeal wire was back-loaded into a standard, 13.4 mm diameter, adult CS using an opan-ended wash-catheter or the catheter portion of a polypectomy snare that had been advanced through the length of the biopsy channel. The catheter was then slowly withdrawn as the guidewire was proportionately advanced until it exited the biopsy port. Finally, the CS was advanced through the sigmoid and into the proximal colon with the use of minimal guidewire tension. Once the CS traversed the sigmoid colon, the guidewire was removed and the CS advanced to the cecum. Results: In each of the 19 cases, the sigmoid angulation/narrowing was traversed and cecal intubation achieved. In no case was the cecum reached with the UGI endoscope. There were no apparent complications other than very minor mucosal trauma due to guidewire passage. Summary: UGI endoscopes successfully traversed areas of sigmoid angulation/uarrowing, but were too short to reach the cecum. Guidewire exchange to a CS permitted the safe completion of colonoscopy with cecal intubation. Conclusion: This guidewire exchange technique appears safe and effective. It should be considered for general use in similar cases.
ACCURACY OF ENDOSCOPIC ULTRASOUND STAGING OF ESOPHAGEAL CARCINOMA AFTER SUCCESSFUL INDUCTION CHEMORADIOTHERAPY R.Pimentel, C~ 7a~ccaro, D.J. Adelstein, T.W. Rice; Cleveland Clinic, Cleveland, Ohio INTROI'311CTIf)N: The accuracy of endoseopie ultrasound (EUS) in pre-operative staging of esophageal carcinoma is well documented, with T stage accuracy and N stage sensitivity of 70-90%. Its ability to predict response to effective induction chemoradiotherapy is less established; an initial experience is presented. MF.TI-IOD.q: 34 patients (8 squamons cell, 26 adenocarcinoma) underwent combination chemotherapy with concurrent radiation therapy, followed by esophagectomy. Initial EUS was possible in 32/34 patients before induction chemoradiotherapy; in 2 patients with strictures no significant information could be obtained. EUS was done in all 34 patients post-induction, prior to surgery.
310
GASTROINTESTINAL ENDOSCOPY
Initial. EUS (n =32) Post-induction EUS (n=34) Esophagectomy/Pathology (n=34)
To
T~2
0 2 13
4 3 10
-T3---T, 28 29 ll(all "1"3)
Of the 13 T o patients at surgery, 1 was ToNt; the other 12/34 (35%) had no residual cancer. EUS predicted no residual cancer in only 1/12 (8%). Overall, the post-induction EUS T stage accuracy was 35%. With respect to N stage, 12 patients had malignant nodes (hit) at surgery/pathology. Initial EUS was positive for N~ in 11/12 cases (sensitivity 92%). Post-induction EUS was positive for N~ in only 5 of these 12 (sensitivity 42%). CONC! JISIORS: EUS does not accurately predict response to induction chemoradiotherapy. Assessment of depth of tumor invasion is limited by inability to distinguish viable tumor from fibrosis and inflammation. Established EUS criteria to distinguish malignant from reactive nodes (size, shape, border characteristics) may not apply after chemoradiotherapy.
VOLUME 41, NO. 4, 1995