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Duodenal stenosis after endoscopic biliary metallic stent placement for malignant biliary stenosis
Duodenal stenosis after endoscopic biliary metallic stent placement for malignant biliary stenosis Takafumi Hyodo, MD, Yukio Yoshida, MD, Takeo Yamanaka, MD, Michio Imawari, MD Saitama, Japan
Background: Some patients who undergo endoscopic insertion of biliary metallic stents for malignant biliary stenosis later develop symptomatic duodenal stenosis due to tumor invasion. Methods: We compared the development of symptomatic duodenal stenosis in patients who had undergone endoscopic biliary metallic stent insertion (metallic stent group) with that in patients who had undergone either endoscopic biliary drainage or percutaneous transhepatic biliary drainage with a plastic stent (nonmetallic stent group). Fourteen patients in the metallic stent group were matched with 14 patients in a nonmetallic stent group. All patients had a Karnofsky performance status score of greater than 90% and were clinical stage IV when they underwent biliary decompression. Results: Although there was no difference in survival time between the 2 groups, 5 of 14 patients in the metallic stent group developed symptomatic duodenal stenosis due to tumor invasion during the observation period whereas this occurred in only 1 of 14 patients in the nonmetallic stent group. Multiple logistic regression analysis indicates that the type of stent (p = 0.022) and survival time (p = 0.002) are 2 independent prognostic factors for the development of symptomatic duodenal stenosis. Conclusions: Patients treated with endoscopic biliary metallic stent insertion are prone to develop symptomatic duodenal stenosis due to tumor invasion compared with those treated with either endoscopic retrograde biliary drainage or percutaneous transhepatic biliary drainage with a plastic stent. (Gastrointest Endosc 2000;52:64-6.)
Several modalities such as endoscopic retrograde biliary drainage with a plastic stent (ERBD) or percutaneous transhepatic biliary drainage with a plastic stent (PTBD) have been used for biliary decompression in malignant biliary stenosis. Recently endoscopic insertion of biliary metallic stents (EBMS) has also been used as an effective palliative treatment for malignant biliary stenosis in patients for whom surgery is not indicated.1,2 Because EBMS decreases the need for additional treatment for obstructive jaundice due to stent occlusion,3-5 successful EBMS offers better quality of life for patients with malignant biliary stenosis compared with ERBD or PTBD. However, our observation is that patients treated with EBMS seem to have a higher incidence of symptomatic duodenal stenosis due to tumor invasion than those treated with Received June 4, 1999. For revision October 14, 1999. Accepted December 22, 1999. From the Division of Gastroenterology and Department of General Medicine I, Omiya Medical Center, Jichi Medical School, Saitama, Japan. Reprint requests: Takafumi Hyodo, MD, Department of General Medicine I, Omiya Medical Center, 1-847 Amanuma-cho, Omiya, Saitama 330-8503, Japan. Copyright © 2000 by the American Society for Gastrointestinal Endoscopy 0016-5107/2000/$12.00 + 0 37/1/105201 doi:10.1067/mge.2000.105201 64
GASTROINTESTINAL ENDOSCOPY
ERBD or PTBD. In the present study, the development of symptomatic duodenal stenosis due to tumor invasion in patients who had undergone EBMS for malignant biliary stenosis was compared with that in patients who had undergone either ERBD or PTBD. PATIENTS AND METHODS From 1997 to 1999, 14 patients with biliary or pancreatic cancers that were at clinical stage IV6 and a Karnofsky performance status score of greater than 90% underwent EBMS for biliary stenosis (metallic stent group) in our institution. These patients were matched, in terms of age, gender, the site and extent of the tumor, stage, and performance status, with 14 patients who were previously treated with either ERBD or PTBD for malignant biliary stenosis from 1994 to 1996 (nonmetallic stent group). From 1994 to 1996, ERBD was used as the initial treatment for decompression of malignant biliary stenosis. When ERBD failed, PTBD was tried. Two of 14 patients in the metallic stent group and none in the nonmetallic stent group were alive at the time of analysis. Wallstents (Schneider Inc., Plymouth, Minn.) of 5, 7, or 9 cm in length and 10 mm in diameter were used for EBMS and were placed endoscopically. For ERBD plastic stents of 7F diameter and 7 cm or 9 cm in length were used (straight or pigtail). PTBD was by means of an 8F stent (pigtail) that was connected to an external drainage bag. Some patients had recurrence of jaundice in which case the same treatment modality was applied. VOLUME 52, NO. 1, 2000
Duodenal stenosis after endoscopic biliary metallic stent placement
T Hyodo, Y Yoshida, T Yamanaka, et al.
Table 1. Patient characteristics for nonmetallic stent and metallic stent groups Age (yr)* Gender (M/F) Diagnosis BiC BmC BsC GBC PC Clinical stage Karnofsky performance status score No. of symptomatic duodenal stenoses Survival (mo)†
Nonmetallic stent
Metallic stent
66.3 ± 12.3 10/4
70.2 ± 8.5 10/4
2 1 3 1 7 IV > 90% 5/14 3 (1-18)
2 1 3 1 7 IV > 90% 1/14 4 (1-19)
BiC, Inferior bile duct cancer (from papilla to superior margin of pancreas); BmC, mid bile duct cancer (from superior margin of pancreas to midpoint between pancreas and porta hepatis); BsC, superior bile duct cancer (from porta hepatis to midpoint between porta and superior margin of pancreas); GBC, gallbladder cancer; PC, pancreatic cancer. *Mean ± SD. †Medial (range).
When patients developed symptoms such as vomiting and epigastric distention, the development of duodenal stenosis was suspected and was confirmed by endoscopy or duodenography. Thus, only symptomatic duodenal stenosis was evaluated in the present study. Statistical analysis except for logistic regression analysis was carried out by using a statistical package (StatView-J 4.5 for Macintosh; SAS Institute, Cary, N.C.). Multiple logistic regression analysis was done by using another statistical package (Statistica; StatSoft, Inc., Tulsa, Okla.).
RESULTS The 2 groups are well matched in terms of age, gender, the site and extent of the tumor, stage, performance status, and survival (Table 1). Survival did not differ significantly between the 2 groups by Kaplan-Meyer analysis. Symptomatic duodenal stenosis developed in 1 patient with inferior bile duct carcinoma in the nonmetallic stent group (7%) and 5 patients (1 with mid bile duct carcinoma, 1 with superior bile duct carcinoma, and 3 with pancreatic cancer) in the metallic stent group (36%) (Table 2). The incidence of symptomatic duodenal stenosis did not differ between the 2 groups by the Fisher exact test (p = 0.09). However, when prognostic factors for symptomatic duodenal stenosis were analyzed by multiple logistic regression analysis for the type of stent inserted, the diagnosis and site of tumors, and survival, the type of stent (p = 0.022) and survival (p = 0.002) were independent prognostic factors. Analysis by Cox proportional hazard model was not possible because the numbers of the patients who developed symptomatic duodenal stenosis were too small. VOLUME 52, NO. 1, 2000
DISCUSSION The present case-controlled study verified our assumption that patients treated with EBMS for malignant biliary stenosis develop symptomatic duodenal stenosis due to tumor invasion at a higher rate than those treated with ERBD or PTCD. However, we cannot exclude the possibility of some biases in this study. This study was retrospective and included patients receiving palliative therapy alone. Tumor size was not assessed, and thus the 2 groups might not be balanced with respect to the size of the tumor. EBMS has become useful for the treatment of malignant biliary stenosis because it decreases the need for additional treatment for obstructive jaundice due to stent occlusion.3-5 We have encountered cases of duodenal stenosis after EBMS and suspected that there is a relationship between EBMS and duodenal stenosis. This was verified by multiple logistic regression analysis. The results indicate that both the use of EBMS and longer patient survival contribute to the development of duodenal stenosis. It is possible that tumors are prevented from growing into the biliary lumen by metallic stents and therefore tend to grow outward from the biliary tree thereby leading to duodenal stenosis. However, further studies with larger numbers of cases are needed to confirm this possibility. Three treatment options are available for patients with duodenal stenosis due to tumor invasion: a bypass operation, radiation, and endoscopic duodenal metallic stent insertion (EDMS).6 A bypass operation may not be indicated for patients in the terminal stages of the disease. Radiation may aggravate GASTROINTESTINAL ENDOSCOPY
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T Hyodo, Y Yoshida, T Yamanaka, et al.
Duodenal stenosis after endoscopic biliary metallic stent placement
Table 2. Symptomatic duodenal stenosis in nonmetallic stent (N) and metallic stent (S) groups Patient No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
Age (yr) 65 75 94 77 74 48 77 79 69 54 57 74 42 43 78 76 60 68 59 79 70 71 57 62 84 80 68 71
Group N N N N N N N N N N N N N N S S S S S S S S S S S S S S
Symptomatic duodenal stenosis + — — — — — — — — — — — — — — — + + — — — + + — — + — —
Interval
Diagnosis*
Survival (mo)†
12
BiC BiC BmC BsC BsC BsC GBC PC PC PC PC PC PC PC BiC BiC BmC BsC BsC BsC GBC PC PC PC PC PC PC PC
18 3 9 2 2 1 4 1 4 6 3 8 1 3 5 1 19 19 6 6 2 10 4 4 4 4 1 1
16 17
8 2
2
*Interval from biliary decompression to symptomatic duodenal stenosis. Table 1 for spell out of abbreviations.
†See
the condition. EDMS has been reported as effective for duodenal stenosis in patients with gastric outlet obstruction due to gastric or pancreatobiliary malignancy.6-11 Two patients in the present study who could only take liquid due to duodenal stenosis were treated by EDMS and both could take solid foods thereafter (unpublished observation). REFERENCES 1. Sobin LH, Wittekind CH. TNM classification of malignant tumor. 5th ed. New York: Wikey-Liss, Inc; 1997. 2. Coons HG. Self-expanding stainless steel biliary stents. Radiology 1989;170:979-83. 3. Adam A, Chetty N, Roddie M. Self-expandable stainless steel endoprostheses for treatment of malignant bile duct obstruction. Am J Radiol 1990;156:321-5. 4. Lammer J, Hausegger KA, Fluckiger F, Winkelbaucer FW, Wildling R, Klein GE. Common bile duct obstruction due to malignancy: treatment with plastic versus metal stents. Radiology 1996;201:167-72.
66
GASTROINTESTINAL ENDOSCOPY
5. Prat F, Chapat O, Ducot B, Ponchon T, Pelletier G, Fritsch J. A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct. Gastrointest Endosc 1998;47:1-7. 6. Hyodo T, Yoshida Y, Imawari M. A new endoscopic metallic stenting method for duodenal stenosis: a preliminary report. J Gastroenterol 1999;34:577-81. 7. Nevitt AW, Vida F, Kozarek RA. Expandable metallic prostheses for malignant obstructions of gastric outlet and proximal small bowel. Gastrointest Endosc 1998;47:271-6. 8. Jaunuschowski R. Stents for the palliative treatment of malignant gastric outlet stenoses. Dtsch Med Wochenschr 1997;122:578-82. 9. Lichtenstein DR. Endoscopic palliation for unresectable pancreatic carcinoma. Surg Clin North Am 1995;75:969-88. 10. Strecker EP, Boos I, Husfeldt KJ. Malignant duodenal stenosis: palliation with peroral implantation of a self-expanding nitinol stent. Radiology 1995;196:349-51. 11. Binkert CA, Jost R, Steiner A. Benign and malignant stenoses of the stomach and duodenum: treatment with self-expanding metallic endoprostheses. Radiology 1996;199:335-8.
VOLUME 52, NO. 1, 2000
Background: Some patients who undergo endoscopic insertion of biliary metallic stents for malignant biliary stenosis later develop symptomatic duodenal stenosis due to tumor invasion. Methods: We compared the development of symptomatic duodenal stenosis in patients who had undergone endoscopic biliary metallic stent insertion (metallic stent group) with that in patients who had undergone either endoscopic biliary drainage or percutaneous transhepatic biliary drainage with a plastic stent (nonmetallic stent group). Fourteen patients in the metallic stent group were matched with 14 patients in a nonmetallic stent group. All patients had a Karnofsky performance status score of greater than 90% and were clinical stage IV when they underwent biliary decompression. Results: Although there was no difference in survival time between the 2 groups, 5 of 14 patients in the metallic stent group developed symptomatic duodenal stenosis due to tumor invasion during the observation period whereas this occurred in only 1 of 14 patients in the nonmetallic stent group. Multiple logistic regression analysis indicates that the type of stent (p = 0.022) and survival time (p = 0.002) are 2 independent prognostic factors for the development of symptomatic duodenal stenosis. Conclusions: Patients treated with endoscopic biliary metallic stent insertion are prone to develop symptomatic duodenal stenosis due to tumor invasion compared with those treated with either endoscopic retrograde biliary drainage or percutaneous transhepatic biliary drainage with a plastic stent. (Gastrointest Endosc 2000;52:64-6.)
Several modalities such as endoscopic retrograde biliary drainage with a plastic stent (ERBD) or percutaneous transhepatic biliary drainage with a plastic stent (PTBD) have been used for biliary decompression in malignant biliary stenosis. Recently endoscopic insertion of biliary metallic stents (EBMS) has also been used as an effective palliative treatment for malignant biliary stenosis in patients for whom surgery is not indicated.1,2 Because EBMS decreases the need for additional treatment for obstructive jaundice due to stent occlusion,3-5 successful EBMS offers better quality of life for patients with malignant biliary stenosis compared with ERBD or PTBD. However, our observation is that patients treated with EBMS seem to have a higher incidence of symptomatic duodenal stenosis due to tumor invasion than those treated with Received June 4, 1999. For revision October 14, 1999. Accepted December 22, 1999. From the Division of Gastroenterology and Department of General Medicine I, Omiya Medical Center, Jichi Medical School, Saitama, Japan. Reprint requests: Takafumi Hyodo, MD, Department of General Medicine I, Omiya Medical Center, 1-847 Amanuma-cho, Omiya, Saitama 330-8503, Japan. Copyright © 2000 by the American Society for Gastrointestinal Endoscopy 0016-5107/2000/$12.00 + 0 37/1/105201 doi:10.1067/mge.2000.105201 64
GASTROINTESTINAL ENDOSCOPY
ERBD or PTBD. In the present study, the development of symptomatic duodenal stenosis due to tumor invasion in patients who had undergone EBMS for malignant biliary stenosis was compared with that in patients who had undergone either ERBD or PTBD. PATIENTS AND METHODS From 1997 to 1999, 14 patients with biliary or pancreatic cancers that were at clinical stage IV6 and a Karnofsky performance status score of greater than 90% underwent EBMS for biliary stenosis (metallic stent group) in our institution. These patients were matched, in terms of age, gender, the site and extent of the tumor, stage, and performance status, with 14 patients who were previously treated with either ERBD or PTBD for malignant biliary stenosis from 1994 to 1996 (nonmetallic stent group). From 1994 to 1996, ERBD was used as the initial treatment for decompression of malignant biliary stenosis. When ERBD failed, PTBD was tried. Two of 14 patients in the metallic stent group and none in the nonmetallic stent group were alive at the time of analysis. Wallstents (Schneider Inc., Plymouth, Minn.) of 5, 7, or 9 cm in length and 10 mm in diameter were used for EBMS and were placed endoscopically. For ERBD plastic stents of 7F diameter and 7 cm or 9 cm in length were used (straight or pigtail). PTBD was by means of an 8F stent (pigtail) that was connected to an external drainage bag. Some patients had recurrence of jaundice in which case the same treatment modality was applied. VOLUME 52, NO. 1, 2000
Duodenal stenosis after endoscopic biliary metallic stent placement
T Hyodo, Y Yoshida, T Yamanaka, et al.
Table 1. Patient characteristics for nonmetallic stent and metallic stent groups Age (yr)* Gender (M/F) Diagnosis BiC BmC BsC GBC PC Clinical stage Karnofsky performance status score No. of symptomatic duodenal stenoses Survival (mo)†
Nonmetallic stent
Metallic stent
66.3 ± 12.3 10/4
70.2 ± 8.5 10/4
2 1 3 1 7 IV > 90% 5/14 3 (1-18)
2 1 3 1 7 IV > 90% 1/14 4 (1-19)
BiC, Inferior bile duct cancer (from papilla to superior margin of pancreas); BmC, mid bile duct cancer (from superior margin of pancreas to midpoint between pancreas and porta hepatis); BsC, superior bile duct cancer (from porta hepatis to midpoint between porta and superior margin of pancreas); GBC, gallbladder cancer; PC, pancreatic cancer. *Mean ± SD. †Medial (range).
When patients developed symptoms such as vomiting and epigastric distention, the development of duodenal stenosis was suspected and was confirmed by endoscopy or duodenography. Thus, only symptomatic duodenal stenosis was evaluated in the present study. Statistical analysis except for logistic regression analysis was carried out by using a statistical package (StatView-J 4.5 for Macintosh; SAS Institute, Cary, N.C.). Multiple logistic regression analysis was done by using another statistical package (Statistica; StatSoft, Inc., Tulsa, Okla.).
RESULTS The 2 groups are well matched in terms of age, gender, the site and extent of the tumor, stage, performance status, and survival (Table 1). Survival did not differ significantly between the 2 groups by Kaplan-Meyer analysis. Symptomatic duodenal stenosis developed in 1 patient with inferior bile duct carcinoma in the nonmetallic stent group (7%) and 5 patients (1 with mid bile duct carcinoma, 1 with superior bile duct carcinoma, and 3 with pancreatic cancer) in the metallic stent group (36%) (Table 2). The incidence of symptomatic duodenal stenosis did not differ between the 2 groups by the Fisher exact test (p = 0.09). However, when prognostic factors for symptomatic duodenal stenosis were analyzed by multiple logistic regression analysis for the type of stent inserted, the diagnosis and site of tumors, and survival, the type of stent (p = 0.022) and survival (p = 0.002) were independent prognostic factors. Analysis by Cox proportional hazard model was not possible because the numbers of the patients who developed symptomatic duodenal stenosis were too small. VOLUME 52, NO. 1, 2000
DISCUSSION The present case-controlled study verified our assumption that patients treated with EBMS for malignant biliary stenosis develop symptomatic duodenal stenosis due to tumor invasion at a higher rate than those treated with ERBD or PTCD. However, we cannot exclude the possibility of some biases in this study. This study was retrospective and included patients receiving palliative therapy alone. Tumor size was not assessed, and thus the 2 groups might not be balanced with respect to the size of the tumor. EBMS has become useful for the treatment of malignant biliary stenosis because it decreases the need for additional treatment for obstructive jaundice due to stent occlusion.3-5 We have encountered cases of duodenal stenosis after EBMS and suspected that there is a relationship between EBMS and duodenal stenosis. This was verified by multiple logistic regression analysis. The results indicate that both the use of EBMS and longer patient survival contribute to the development of duodenal stenosis. It is possible that tumors are prevented from growing into the biliary lumen by metallic stents and therefore tend to grow outward from the biliary tree thereby leading to duodenal stenosis. However, further studies with larger numbers of cases are needed to confirm this possibility. Three treatment options are available for patients with duodenal stenosis due to tumor invasion: a bypass operation, radiation, and endoscopic duodenal metallic stent insertion (EDMS).6 A bypass operation may not be indicated for patients in the terminal stages of the disease. Radiation may aggravate GASTROINTESTINAL ENDOSCOPY
65
T Hyodo, Y Yoshida, T Yamanaka, et al.
Duodenal stenosis after endoscopic biliary metallic stent placement
Table 2. Symptomatic duodenal stenosis in nonmetallic stent (N) and metallic stent (S) groups Patient No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
Age (yr) 65 75 94 77 74 48 77 79 69 54 57 74 42 43 78 76 60 68 59 79 70 71 57 62 84 80 68 71
Group N N N N N N N N N N N N N N S S S S S S S S S S S S S S
Symptomatic duodenal stenosis + — — — — — — — — — — — — — — — + + — — — + + — — + — —
Interval
Diagnosis*
Survival (mo)†
12
BiC BiC BmC BsC BsC BsC GBC PC PC PC PC PC PC PC BiC BiC BmC BsC BsC BsC GBC PC PC PC PC PC PC PC
18 3 9 2 2 1 4 1 4 6 3 8 1 3 5 1 19 19 6 6 2 10 4 4 4 4 1 1
16 17
8 2
2
*Interval from biliary decompression to symptomatic duodenal stenosis. Table 1 for spell out of abbreviations.
†See
the condition. EDMS has been reported as effective for duodenal stenosis in patients with gastric outlet obstruction due to gastric or pancreatobiliary malignancy.6-11 Two patients in the present study who could only take liquid due to duodenal stenosis were treated by EDMS and both could take solid foods thereafter (unpublished observation). REFERENCES 1. Sobin LH, Wittekind CH. TNM classification of malignant tumor. 5th ed. New York: Wikey-Liss, Inc; 1997. 2. Coons HG. Self-expanding stainless steel biliary stents. Radiology 1989;170:979-83. 3. Adam A, Chetty N, Roddie M. Self-expandable stainless steel endoprostheses for treatment of malignant bile duct obstruction. Am J Radiol 1990;156:321-5. 4. Lammer J, Hausegger KA, Fluckiger F, Winkelbaucer FW, Wildling R, Klein GE. Common bile duct obstruction due to malignancy: treatment with plastic versus metal stents. Radiology 1996;201:167-72.
66
GASTROINTESTINAL ENDOSCOPY
5. Prat F, Chapat O, Ducot B, Ponchon T, Pelletier G, Fritsch J. A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct. Gastrointest Endosc 1998;47:1-7. 6. Hyodo T, Yoshida Y, Imawari M. A new endoscopic metallic stenting method for duodenal stenosis: a preliminary report. J Gastroenterol 1999;34:577-81. 7. Nevitt AW, Vida F, Kozarek RA. Expandable metallic prostheses for malignant obstructions of gastric outlet and proximal small bowel. Gastrointest Endosc 1998;47:271-6. 8. Jaunuschowski R. Stents for the palliative treatment of malignant gastric outlet stenoses. Dtsch Med Wochenschr 1997;122:578-82. 9. Lichtenstein DR. Endoscopic palliation for unresectable pancreatic carcinoma. Surg Clin North Am 1995;75:969-88. 10. Strecker EP, Boos I, Husfeldt KJ. Malignant duodenal stenosis: palliation with peroral implantation of a self-expanding nitinol stent. Radiology 1995;196:349-51. 11. Binkert CA, Jost R, Steiner A. Benign and malignant stenoses of the stomach and duodenum: treatment with self-expanding metallic endoprostheses. Radiology 1996;199:335-8.
VOLUME 52, NO. 1, 2000