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The Usefulness of Colonoscopy in Ischemic Colitis
Abstracts
T1391 Microcrystalline Cellulose-Free NaP Tablets (INKP-102) Achieve Comparable Overall and Superior Ascending Colon Cleansing Rates Versus VisicolÒ Tablets: A Pooled Analysis of Phase II and III Trials Douglas Rex
T1393 Association of Obesity, Serum Glucose and Lipids with the Risk of Advanced Colorectal Adenoma and Cancer: A Case-Control Study in Korea Yong Woo Chung, Dong Soo Han, Yoon Kyung Park, Byoung Kwan Son, Chang Hee Paik, Yong Cheol Jeon, Joo Hyun Sohn
Background: VisicolÒ (Salix Pharmaceuticals, Inc, Morrisville, NC) contains 13% microcrystalline cellulose (MCC), an excipient which can leave a residue, usually in the ascending colon, and impair full visibility during a colonoscopy. A new MCC-free sodium phosphate (NaP) tablet formulation, INKP-102, has been developed as an alternative bowel purgative to Visicol. Prior data have shown 32 tablets of INKP-102 to be preferred by patients and better tolerated than 40 Visicol tablets. To fully evaluate the efficacy of INKP-102 versus Visicol, a pooled efficacy analysis of phase 2 and phase 3 randomized, clinical trials was conducted. Methods: Patients received INKP-102 40 (60 g) or 32 tablets (48 g), 4 tablets at a time, or Visicol 40 tablets (60 g), 3 tablets at a time. Overall colon cleansing (OCC) and ascending colon cleansing (ACC) were assessed by a physician questionnaire using a 4-point scale, based on colonic contents. Patients were considered responders if they achieved a rating of ‘‘excellent’’ (O90% of mucosa observed, mostly liquid colonic contents, minimal suctioning required) or ‘‘good’’ (O90% of mucosa observed, mostly liquid stool, significant suctioning required) colon cleansing. Results: All randomized patients who received at least 1 dose of study medication and underwent a colonoscopy were included: 262, 269, and 264 patients treated with INKP-102 40 tablets, INKP102 32 tablets, and Visicol 40 tablets, respectively. A large, comparable percentage of OCC responders was reported in all groups; 97% and 96% for INKP-102 40 and 32 tablets, respectively, compared with 94% for Visicol 40 tablets. However, a significantly larger number of ACC responders was observed with INKP-102 40 (96%) and 32 tablets (94%) compared with Visicol 40 tablets (88%; P Z 0.0006 and P Z 0.0090 versus INKP-102 40 and 32 tablets, respectively). Of these responses, 74% and 76% were rated as excellent with INKP-102 40 and 32 tablets, respectively, compared with 51% with Visicol 40 tablets. Conclusion: This pooled analysis demonstrates that patients treated with 32 tablets of INKP-102 achieve a comparable OCC response and a superior ACC response compared with patients receiving 40 tablets of Visicol. The absence of MCC in INKP-102 may account for the differences in ACC response observed. The benefits of this new tablet NaP formulation suggest INKP-102 will be the first choice for tablet bowel purgatives.
Background: Previous studies on life style for colon cancer risk suggest that obesity, serum lipids and glucose might be related to colorectal adenomas as well as to colorectal carcinogenesis. This case-control study was conducted to investigate the association between obesity, serum lipids and glucose, and the risk of advanced colorectal adenoma and cancer. Methods: Patients with histologically confirmed colorectal cancers (n Z 105), same number of patients with advanced colorectal adenomas matched by age and sex, and the same number of controls matched by age and sex were selected in Hanyang University Guri Hospital between January 2002 and June 2004. Results: Adenoma group showed significantly higher levels of mean BMI (p ! 0.01), serum glucose (p ! 0.01) and triglyceride (p ! 0.05). In cancer group, mean BMI and serum lipids levels were significantly lower than adenoma group (p ! 0.01), but mean serum glucose level was higher than adenoma group (p Z 0.19). In logistic regression analysis, there was a significant trend of increasing advanced colorectal adenoma risk with the rise in BMI (ptrend ! 0.001). Increasing trend for the risk with fasting serum glucose was also seen (ptrend Z 0.08). Both triglyceride and cholesterol were not stastically significant. Conclusions: Obesity and hyperglycemia are positively related to the increased risk of advanced colorectal adenomas. In this regard, insulin resistance associated with glucose intolerance is thought to play a role in colorectal carcinogenesis. Lower levels of BMI and serum lipids in patients with colon cancer may be the results of nutritional and metabolic changes in advanced cancer patients, not the direct causes of colon cancer.
T1392 The Usefulness of Colonoscopy in Ischemic Colitis Kum Hei Ryu, Ki-Nam Shim, Seong-Eun Kim, Hee Jung Oh, Hyun Joo Song, Ji Hyun Song, Hye Jung Yeom, Tae Hun Kim, Hye Kyoung Jung, Sung-Ae Jung, Sun Young Yi, Kwon Yoo, Il-Hwan Moon, Kyu Won Chung Background/Aims: The aim of this study was to investigate relationships between the clinical manifestation and the colonoscopic findings of ischemic colitis and the usefulness of colonoscopy in this disease. Methods: Data of patients diagnosed with ischemic colitis by colonoscopic examination were analyzed retrospectively. The involved lesions were described by 6 segments which were divided from rectum to cecum. The mucosal findings were described as erythema, edema, submucosal hemorrhage, ulcer, gangrenous change, luminal narrowing, and luminal stenosis. Statistical analysis was done by dividing into two groups according to whether the involved segments were more than 3 or not (multisegmented group vs. nonmultisegmented group) and dividing into other two groups whether the mucosal findings were gangrenous or not (gangrenous group vs. non-gangrenous group). Results: 69 patients (mean age 60.5 G 18.7 years, M:F Z 20:49) were included. The most common coexisting medical condition was hypertension (43.5%), and the most common presenting symptoms were hematochezia (59.4%) and abdominal pain (34.8%). The colonoscopy was performed, on the average, 4.8 days after the symptom developed. The most common involved segment was sigmoid colon (82.6%), and the rest involved segments were in the order as follows: descending colon, splenic flexure, rectum, transverse colon, and ascending colon. The levels of total protein, albumin, and cholesterol were significantly lower in the multisegmented group (n Z 17) than in the non-multisegmented group (n Z 52) (p Z 0.003, p Z 0.026, p Z 0.007), but there was no significant difference in the operation rate between the two groups. In the comparison between the gangrenous group (n Z 12) and the non-gangrenous group (n Z 57), WBC count and the level of serum glucose were significantly higher in the gangrenous group (p Z 0.007, p Z 0.048). The operation rate was also higher in the gangrenous group (33.3%) than in the non-gangrenous group (3.5%)(p Z 0.011). Conclusion: Evaluation of the mucosal severities and the extent of the disease by colonoscopy may be helpful in predicting clinical status and the prognosis of the patients.
AB212 GASTROINTESTINAL ENDOSCOPY Volume 63, No. 5 : 2006
T1394 The Frequency of Synchronous Adenomas Detected At Colonoscopic Removal of Early Colorectal Cancers Seiji Kimura, Masanori Tanaka Background and Aims: Synchronous adenomas are often detected when colonoscopic removals of early colorectal cancers are carried out. The study aimed to evaluate whether or not the removed early cancers had any characteristics associated with the presence of synchronous adenoma. Methods: The study included a total of 253 early colorectal cancers (221 intramucosal and 32 submucosal invasive cancers), which were colonoscopically removed in our hospital during past 10 years. We analyzed the relationships between the following characteristics of resected early cancers and the presence of synchronous adenomas : location, tumor size, endoscopic configuration, histology, and depth of invasion. Results: The overall percentage of synchronous adenoma at colonoscopic removals of early colorectal cancers was 43.5%. Almost half of the resected early cancers were associated with synchronous adenoma(s) during colonoscopy. With regard to the location of removed cancers the prevalences of synchronous adenoma(s) were 45.2% (right colon), 45.8% (left colon), and 38.0% (rectum), respectively. No difference was statistically observed according to the location of original tumor. Regarding the size of removed cancers the prevalences of synchronous adenoma(s) were 56.4% (!10 mm), 38.4% (10 mm-20 mm), and 27.5% (O20 mm). Prevalence of adenoma(s) became to be lower according to the size up of removed tumor (p ! 0.005). Regarding the endoscopic configuration of removed cancers the prevalences of synchronous adenoma(s) were 48.8% (pedunculated type), 45.1% (sessile type), 31.3% (flat type), and 24.2% (superficial spreading type), respectively. Polypoid type cancer (pedunculated or sessile type) had higher prevalences of synchronous adenoma(s) when compared to those of non-polypoid type (flat or superficial spreading type) (p ! 0.05). As to the histology of removed cancers the prevalences of synchronous adenoma(s) were 43.4% (tubular adenocarcinoma), and 43.6% (villous adenocarcinoma), respectively. No statistical difference was observed between them. As to the depth of invasion the prevalences of synchronous adenoma (s) were 46.2% (m), and 25.0% (sm). Adenomas were less frequent with submucosal invasive cancers (p ! 0.05). Conclusion: The characteristics of colonoscopically removed early cancers might influence on the prevalence of adenomas at colonoscopy. Size, configuration, and depth of invasion of removed cancers might be significant factors which influence on the frequency of synchronous adenomas.
www.giejournal.org
T1391 Microcrystalline Cellulose-Free NaP Tablets (INKP-102) Achieve Comparable Overall and Superior Ascending Colon Cleansing Rates Versus VisicolÒ Tablets: A Pooled Analysis of Phase II and III Trials Douglas Rex
T1393 Association of Obesity, Serum Glucose and Lipids with the Risk of Advanced Colorectal Adenoma and Cancer: A Case-Control Study in Korea Yong Woo Chung, Dong Soo Han, Yoon Kyung Park, Byoung Kwan Son, Chang Hee Paik, Yong Cheol Jeon, Joo Hyun Sohn
Background: VisicolÒ (Salix Pharmaceuticals, Inc, Morrisville, NC) contains 13% microcrystalline cellulose (MCC), an excipient which can leave a residue, usually in the ascending colon, and impair full visibility during a colonoscopy. A new MCC-free sodium phosphate (NaP) tablet formulation, INKP-102, has been developed as an alternative bowel purgative to Visicol. Prior data have shown 32 tablets of INKP-102 to be preferred by patients and better tolerated than 40 Visicol tablets. To fully evaluate the efficacy of INKP-102 versus Visicol, a pooled efficacy analysis of phase 2 and phase 3 randomized, clinical trials was conducted. Methods: Patients received INKP-102 40 (60 g) or 32 tablets (48 g), 4 tablets at a time, or Visicol 40 tablets (60 g), 3 tablets at a time. Overall colon cleansing (OCC) and ascending colon cleansing (ACC) were assessed by a physician questionnaire using a 4-point scale, based on colonic contents. Patients were considered responders if they achieved a rating of ‘‘excellent’’ (O90% of mucosa observed, mostly liquid colonic contents, minimal suctioning required) or ‘‘good’’ (O90% of mucosa observed, mostly liquid stool, significant suctioning required) colon cleansing. Results: All randomized patients who received at least 1 dose of study medication and underwent a colonoscopy were included: 262, 269, and 264 patients treated with INKP-102 40 tablets, INKP102 32 tablets, and Visicol 40 tablets, respectively. A large, comparable percentage of OCC responders was reported in all groups; 97% and 96% for INKP-102 40 and 32 tablets, respectively, compared with 94% for Visicol 40 tablets. However, a significantly larger number of ACC responders was observed with INKP-102 40 (96%) and 32 tablets (94%) compared with Visicol 40 tablets (88%; P Z 0.0006 and P Z 0.0090 versus INKP-102 40 and 32 tablets, respectively). Of these responses, 74% and 76% were rated as excellent with INKP-102 40 and 32 tablets, respectively, compared with 51% with Visicol 40 tablets. Conclusion: This pooled analysis demonstrates that patients treated with 32 tablets of INKP-102 achieve a comparable OCC response and a superior ACC response compared with patients receiving 40 tablets of Visicol. The absence of MCC in INKP-102 may account for the differences in ACC response observed. The benefits of this new tablet NaP formulation suggest INKP-102 will be the first choice for tablet bowel purgatives.
Background: Previous studies on life style for colon cancer risk suggest that obesity, serum lipids and glucose might be related to colorectal adenomas as well as to colorectal carcinogenesis. This case-control study was conducted to investigate the association between obesity, serum lipids and glucose, and the risk of advanced colorectal adenoma and cancer. Methods: Patients with histologically confirmed colorectal cancers (n Z 105), same number of patients with advanced colorectal adenomas matched by age and sex, and the same number of controls matched by age and sex were selected in Hanyang University Guri Hospital between January 2002 and June 2004. Results: Adenoma group showed significantly higher levels of mean BMI (p ! 0.01), serum glucose (p ! 0.01) and triglyceride (p ! 0.05). In cancer group, mean BMI and serum lipids levels were significantly lower than adenoma group (p ! 0.01), but mean serum glucose level was higher than adenoma group (p Z 0.19). In logistic regression analysis, there was a significant trend of increasing advanced colorectal adenoma risk with the rise in BMI (ptrend ! 0.001). Increasing trend for the risk with fasting serum glucose was also seen (ptrend Z 0.08). Both triglyceride and cholesterol were not stastically significant. Conclusions: Obesity and hyperglycemia are positively related to the increased risk of advanced colorectal adenomas. In this regard, insulin resistance associated with glucose intolerance is thought to play a role in colorectal carcinogenesis. Lower levels of BMI and serum lipids in patients with colon cancer may be the results of nutritional and metabolic changes in advanced cancer patients, not the direct causes of colon cancer.
T1392 The Usefulness of Colonoscopy in Ischemic Colitis Kum Hei Ryu, Ki-Nam Shim, Seong-Eun Kim, Hee Jung Oh, Hyun Joo Song, Ji Hyun Song, Hye Jung Yeom, Tae Hun Kim, Hye Kyoung Jung, Sung-Ae Jung, Sun Young Yi, Kwon Yoo, Il-Hwan Moon, Kyu Won Chung Background/Aims: The aim of this study was to investigate relationships between the clinical manifestation and the colonoscopic findings of ischemic colitis and the usefulness of colonoscopy in this disease. Methods: Data of patients diagnosed with ischemic colitis by colonoscopic examination were analyzed retrospectively. The involved lesions were described by 6 segments which were divided from rectum to cecum. The mucosal findings were described as erythema, edema, submucosal hemorrhage, ulcer, gangrenous change, luminal narrowing, and luminal stenosis. Statistical analysis was done by dividing into two groups according to whether the involved segments were more than 3 or not (multisegmented group vs. nonmultisegmented group) and dividing into other two groups whether the mucosal findings were gangrenous or not (gangrenous group vs. non-gangrenous group). Results: 69 patients (mean age 60.5 G 18.7 years, M:F Z 20:49) were included. The most common coexisting medical condition was hypertension (43.5%), and the most common presenting symptoms were hematochezia (59.4%) and abdominal pain (34.8%). The colonoscopy was performed, on the average, 4.8 days after the symptom developed. The most common involved segment was sigmoid colon (82.6%), and the rest involved segments were in the order as follows: descending colon, splenic flexure, rectum, transverse colon, and ascending colon. The levels of total protein, albumin, and cholesterol were significantly lower in the multisegmented group (n Z 17) than in the non-multisegmented group (n Z 52) (p Z 0.003, p Z 0.026, p Z 0.007), but there was no significant difference in the operation rate between the two groups. In the comparison between the gangrenous group (n Z 12) and the non-gangrenous group (n Z 57), WBC count and the level of serum glucose were significantly higher in the gangrenous group (p Z 0.007, p Z 0.048). The operation rate was also higher in the gangrenous group (33.3%) than in the non-gangrenous group (3.5%)(p Z 0.011). Conclusion: Evaluation of the mucosal severities and the extent of the disease by colonoscopy may be helpful in predicting clinical status and the prognosis of the patients.
AB212 GASTROINTESTINAL ENDOSCOPY Volume 63, No. 5 : 2006
T1394 The Frequency of Synchronous Adenomas Detected At Colonoscopic Removal of Early Colorectal Cancers Seiji Kimura, Masanori Tanaka Background and Aims: Synchronous adenomas are often detected when colonoscopic removals of early colorectal cancers are carried out. The study aimed to evaluate whether or not the removed early cancers had any characteristics associated with the presence of synchronous adenoma. Methods: The study included a total of 253 early colorectal cancers (221 intramucosal and 32 submucosal invasive cancers), which were colonoscopically removed in our hospital during past 10 years. We analyzed the relationships between the following characteristics of resected early cancers and the presence of synchronous adenomas : location, tumor size, endoscopic configuration, histology, and depth of invasion. Results: The overall percentage of synchronous adenoma at colonoscopic removals of early colorectal cancers was 43.5%. Almost half of the resected early cancers were associated with synchronous adenoma(s) during colonoscopy. With regard to the location of removed cancers the prevalences of synchronous adenoma(s) were 45.2% (right colon), 45.8% (left colon), and 38.0% (rectum), respectively. No difference was statistically observed according to the location of original tumor. Regarding the size of removed cancers the prevalences of synchronous adenoma(s) were 56.4% (!10 mm), 38.4% (10 mm-20 mm), and 27.5% (O20 mm). Prevalence of adenoma(s) became to be lower according to the size up of removed tumor (p ! 0.005). Regarding the endoscopic configuration of removed cancers the prevalences of synchronous adenoma(s) were 48.8% (pedunculated type), 45.1% (sessile type), 31.3% (flat type), and 24.2% (superficial spreading type), respectively. Polypoid type cancer (pedunculated or sessile type) had higher prevalences of synchronous adenoma(s) when compared to those of non-polypoid type (flat or superficial spreading type) (p ! 0.05). As to the histology of removed cancers the prevalences of synchronous adenoma(s) were 43.4% (tubular adenocarcinoma), and 43.6% (villous adenocarcinoma), respectively. No statistical difference was observed between them. As to the depth of invasion the prevalences of synchronous adenoma (s) were 46.2% (m), and 25.0% (sm). Adenomas were less frequent with submucosal invasive cancers (p ! 0.05). Conclusion: The characteristics of colonoscopically removed early cancers might influence on the prevalence of adenomas at colonoscopy. Size, configuration, and depth of invasion of removed cancers might be significant factors which influence on the frequency of synchronous adenomas.
www.giejournal.org