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Comparison of 4 L of PEG vs Combination of 2 L of PEG and 45 ml of Sodium Phosphate for Colonoscopy Colon Cleansing: A Prospective Randomized Trial
Abstracts
T1411 Comparison of Pelican Single-Use Multi-Bite Biopsy Forceps vs Traditional Double-Bite Forceps: Evaluation in a Porcine Model Jeffrey Zaidman, William Frederick, Gregory Ginsberg, Chinyu Su Background: Multi-bite biopsy forceps are intended for consecutive acquisition of numerous tissue specimens with a single pass. The Pelican multi-bite forceps is modified wherein the well of one cup is equipped with a sleeve for tissue retention. This allows up to six specimens to be obtained with each pass through the accessory channel. Reducing the need for device exchange could decrease total procedure time for colon cancer surveillance in patients with longstanding inflammatory bowel disease (IBD) and encourage physicians to obtain more biopsy specimens, thereby enhancing yield. The aim of this study was to evaluate a new multi-bite biopsy forceps in comparison to a standard double-bite forceps. Methods: Using a live porcine model, multiple colonoscopic biopsies were obtained to mimic protocol for colorectal cancer surveillance in IBD patients. Following a brief training period, four trials of thirty-six biopsies throughout the colon were completed with both the Pelican multi-bite forceps and Radial Jaw 3 (RJ3) double-bite forceps. Six biopsies were obtained with each of six passes using the Pelican forceps, and two biopsies were obtained with each of eighteen passes using the RJ3. Specimens were fixed in formalin and processed for histological inspection. Trials were timed for total procedure time. A single pathologist blinded to the forceps used evaluated the specimens for tissue size, tissue depth, crush artifact, fixation, and general acceptability for diagnosis. Results: The mean procedure time was 13.32 min for the RJ3 and 8.50 min for the Pelican forceps (p ! 0.01). Of 144 bites with both the RJ3 and Pelican forceps, 121 (84%) specimens were recovered from the RJ3, and 115 (80%) from the Pelican (p Z 0.19, NS). The specimens from both forceps were comparable with respect to size (1-2 mm), depth scale (including muscularis mucosa with or without submucosa), crush artifact, fixation, and acceptability for diagnosis. Conclusion: Tissue acquisition using the Pelican multi-bite forceps was significantly faster than with standard double-bite forceps. The devices compared equivalently for specimen retention and quality. These findings support evaluation of the Pelican forceps for colon cancer surveillance in patients with longstanding IBD.
T1412 Automated Endoscopic Biopsy with Serial Collection, Storage and Processing of Specimens in Situ David S. Zimmon Endoscopic biopsy is a laborious, expensive process in both the endoscopy suite and pathology laboratory. Current endoscopic forceps biopsy is an extension of rigid surgical punch biopsy that has not evolved. A new automated endoscopic biopsy (AEB) forceps biopsy instrument collects up to 24 specimens in a single pass through the endoscope. The biopsies are serially collected and stored within the tip of the AEB device in the order of acquisition. After use, the tip containing the biopsies is separated from the shaft, placed in fixative and submitted to pathology. Biopsy storage in the tip prevents specimen loss and contamination. Obligatory disposal of the biopsy instrument for specimen processing assures that unauthorized reuse is impossible. An endoscopic log identifies the indication and site of each specimen. In pathology the specimens, still contained within the tip, are processed into paraffin, sliced on a microtome, mounted on a single slide and stained for interpretation. The serially collected, stored and processed biopsies appear on the slide in the order of acquisition as documented in the endoscopic log. An AEB is sharply cut and smaller (1.5x1 mm) than prior forceps biopsies but do not have crush or shear artifacts. Prior studies demonstrate the superior diagnostic value of multiple rather than larger biopsies (Gut 1985;26:227& Gastrointest Endosc 1999;49:177). AEB facilitates multiple biopsy and reduces the time and cost of biopsy. An endoscopic assistant is not needed for the right hand to open and close the instrument while the left hand controls the endoscope. This saves 3 minutes for each biopsy that previously were required to pass a biopsy instrument, biopsy, remove the biopsy into fixative and repass for a second biopsy. Staff exposure to infectious material and fixative is minimized in endoscopy and pathology. In the pathology laboratory, specimen handling and preparation is minimized reducing costs. AEB solves many problems of prior endoscopy biopsy and processing of small specimens. These improvements reduce the duration, cost and risk to staff of endoscopic biopsy in both the endoscopy suite and pathology laboratory.
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W1078 Comparison of 4 L of PEG vs Combination of 2 L of PEG and 45 ml of Sodium Phosphate for Colonoscopy Colon Cleansing: A Prospective Randomized Trial Yoon Tae Jeen, Jong Jin Hyun, Hoon Jai Chun, Sang Kyun Yu, Rok Son Choung, Hwang Rae Chun, Young Sik Kim, Hong Sik Lee, Soon Ho Um, Sang Woo Lee, Jai Hyun Choi, Chang Duk Kim, Ho Sang Ryu, Jin Hai Hyun Background: Polyethyleneglycol(PEG) is a widely used colon cleansing agent. It is an iso-osmotic electrolyte solution which induces diarrhea through electrochemical effect of sodium sulfate. The safety of PEG has been confirmed but due to large volume and salty and rotten taste, patients’ compliance can be reduced. On the other hand, sodium phosphate(NaP) is a hyperosmotic agent which induces diarrhea though osmotic effect. Since the volume is smaller, it can increase patients’ compliance. However, there have been concerns about electrolyte imbalance. Therefore, we conducted a study to see whether patients’ compliance can be enhanced and electrolyte imbalance reduced by combining these two agents. Patients and Methods: 41 patients who had colonoscopy while being admitted at Korea University Anam Hospital from June 28, 2004 to August 14, 2004, were randomly divided into two groups to do colon cleansing with either 4 L of PEG(n Z 21) or 2 L of PEG plus 45 mL of NaP(n Z 20). Patients were assessed on patient tolerance, quality of preparation, and changes of biochemical parameters. As for patient tolerance, fullness, nausea, vomiting, cramp, and overall discomfort were evaluated ranging from none, mild, bothersome, distressing, and severely distressing. Quality of preparation was evaluated using Aronchick scoring scale. Na, K, Cl, P, Ca, Mg, and Osm were measured before and after the colon cleansing to evaluate the electrolyte changes. Results: There were no statistical differences among patients’ baseline characteristics. Overall discomfort was statistically lower in the combination group(p Z 0.035). Although patients in the combination group reported less fullness (p Z 0.076) and nausea (p Z 0.087), it was not statistically significant. Quality of preparation was comparable between the two groups (p Z 0.872) with most of the patients showing excellent or good preparation. The phosphorus level showed statistically significant increase (0.58¡3/40.46) compared to the PEG group after colon cleansing (p Z 0.020) but not to the range for it to be clinically significant. The changes of the other biochemical markers were insignificant. Conclusion: The combination of NaP 45 mL and PEG 2 L showed less overall discomfort with comparable quality of preparation and without serious electrolyte abnormality compared to 4 L of PEG. Therefore, the combination could be used as an alternative colonoscopic colon cleansing agent when patients have trouble taking 4 L of PEG alone
W1079 Appropriate Utilization of Adjuvant Therapy Following Colorectal Cancer Diagnosis Neena S. Abraham, Jennifer Kramer, Travis Gossey, Jessica Davila Background: Adjuvant chemotherapy and or radiotherapy in patients with stage II/ III colorectal cancer can reduce the risk of local recurrence and prevent systemic involvement. Data suggest less than 50% of eligible patients receive adjuvant therapy at non-VA facilities. Our aim was to: 1) ascertain if underutilization of adjuvant therapies exist, and 2) assess determinants of this utilization. Methods: We conducted a retrospective cohort study at the Michael E. DeBakey Veteran’s Affairs Medical Center (MEDVAMC). Administrative data identified all patients with a diagnostic code for colorectal cancer (1999-2003). The medical chart of eligible patients was then abstracted to identify an incident cohort with stage II or III colorectal cancer. Our outcome of interest was the utilization of adjuvant chemo or radiotherapy, as defined by the National Cancer Institute. Logistic regression examined potential patient and provider determinants of receipt of adjuvant therapy. Results: One hundred and ninety seven incident cases were diagnosed or received treatment at the MEDVAMC. The mean age of the population was 66 years (SD 11 yrs), 64% were Caucasian and 98.5% were male. A gastroenterologist diagnosed the majority of tumors (72.5%). There were 62 stage II colon cancers; 62 stage III colon cancers; and 73 stage II/III rectal cancers. Referral to oncology was observed in 76% of stage II colon, 92% of stage III colon, and 99% of rectal cancers. 87% of stage II and 71% of stage III colon cancer patients received adjuvant therapy. However, among rectal cancer patients, only 42.5% received appropriate adjuvant therapy. Among 57.5% eligible rectal cancer patients, 36% were poor medical candidates, 15% declined therapy, 18% had their physician deem adjuvant therapy unnecessary, and 32% died prior to follow-up or experienced postoperative complications. Among rectal cancer patients predictors of adjuvant therapy included being married (OR 3.5; 95% CI: 1.3-9.4), presentation at tumor board (OR 2.4; 95% CI: 1.4-10.5) or age less than 65 years (OR 3.5; 95% CI: 1.3-9.3). Conclusions: A substantial proportion of colon cancer patients at a major VA medical center are receiving appropriate adjuvant therapy. Underutilization of adjuvant therapy among rectal cancer patients was observed. Younger or married rectal cancer patients and those presented at tumor board are most likely to receive adjuvant therapy.
Volume 61, No. 5 : 2005 GASTROINTESTINAL ENDOSCOPY AB245
T1411 Comparison of Pelican Single-Use Multi-Bite Biopsy Forceps vs Traditional Double-Bite Forceps: Evaluation in a Porcine Model Jeffrey Zaidman, William Frederick, Gregory Ginsberg, Chinyu Su Background: Multi-bite biopsy forceps are intended for consecutive acquisition of numerous tissue specimens with a single pass. The Pelican multi-bite forceps is modified wherein the well of one cup is equipped with a sleeve for tissue retention. This allows up to six specimens to be obtained with each pass through the accessory channel. Reducing the need for device exchange could decrease total procedure time for colon cancer surveillance in patients with longstanding inflammatory bowel disease (IBD) and encourage physicians to obtain more biopsy specimens, thereby enhancing yield. The aim of this study was to evaluate a new multi-bite biopsy forceps in comparison to a standard double-bite forceps. Methods: Using a live porcine model, multiple colonoscopic biopsies were obtained to mimic protocol for colorectal cancer surveillance in IBD patients. Following a brief training period, four trials of thirty-six biopsies throughout the colon were completed with both the Pelican multi-bite forceps and Radial Jaw 3 (RJ3) double-bite forceps. Six biopsies were obtained with each of six passes using the Pelican forceps, and two biopsies were obtained with each of eighteen passes using the RJ3. Specimens were fixed in formalin and processed for histological inspection. Trials were timed for total procedure time. A single pathologist blinded to the forceps used evaluated the specimens for tissue size, tissue depth, crush artifact, fixation, and general acceptability for diagnosis. Results: The mean procedure time was 13.32 min for the RJ3 and 8.50 min for the Pelican forceps (p ! 0.01). Of 144 bites with both the RJ3 and Pelican forceps, 121 (84%) specimens were recovered from the RJ3, and 115 (80%) from the Pelican (p Z 0.19, NS). The specimens from both forceps were comparable with respect to size (1-2 mm), depth scale (including muscularis mucosa with or without submucosa), crush artifact, fixation, and acceptability for diagnosis. Conclusion: Tissue acquisition using the Pelican multi-bite forceps was significantly faster than with standard double-bite forceps. The devices compared equivalently for specimen retention and quality. These findings support evaluation of the Pelican forceps for colon cancer surveillance in patients with longstanding IBD.
T1412 Automated Endoscopic Biopsy with Serial Collection, Storage and Processing of Specimens in Situ David S. Zimmon Endoscopic biopsy is a laborious, expensive process in both the endoscopy suite and pathology laboratory. Current endoscopic forceps biopsy is an extension of rigid surgical punch biopsy that has not evolved. A new automated endoscopic biopsy (AEB) forceps biopsy instrument collects up to 24 specimens in a single pass through the endoscope. The biopsies are serially collected and stored within the tip of the AEB device in the order of acquisition. After use, the tip containing the biopsies is separated from the shaft, placed in fixative and submitted to pathology. Biopsy storage in the tip prevents specimen loss and contamination. Obligatory disposal of the biopsy instrument for specimen processing assures that unauthorized reuse is impossible. An endoscopic log identifies the indication and site of each specimen. In pathology the specimens, still contained within the tip, are processed into paraffin, sliced on a microtome, mounted on a single slide and stained for interpretation. The serially collected, stored and processed biopsies appear on the slide in the order of acquisition as documented in the endoscopic log. An AEB is sharply cut and smaller (1.5x1 mm) than prior forceps biopsies but do not have crush or shear artifacts. Prior studies demonstrate the superior diagnostic value of multiple rather than larger biopsies (Gut 1985;26:227& Gastrointest Endosc 1999;49:177). AEB facilitates multiple biopsy and reduces the time and cost of biopsy. An endoscopic assistant is not needed for the right hand to open and close the instrument while the left hand controls the endoscope. This saves 3 minutes for each biopsy that previously were required to pass a biopsy instrument, biopsy, remove the biopsy into fixative and repass for a second biopsy. Staff exposure to infectious material and fixative is minimized in endoscopy and pathology. In the pathology laboratory, specimen handling and preparation is minimized reducing costs. AEB solves many problems of prior endoscopy biopsy and processing of small specimens. These improvements reduce the duration, cost and risk to staff of endoscopic biopsy in both the endoscopy suite and pathology laboratory.
www.mosby.com/gie
W1078 Comparison of 4 L of PEG vs Combination of 2 L of PEG and 45 ml of Sodium Phosphate for Colonoscopy Colon Cleansing: A Prospective Randomized Trial Yoon Tae Jeen, Jong Jin Hyun, Hoon Jai Chun, Sang Kyun Yu, Rok Son Choung, Hwang Rae Chun, Young Sik Kim, Hong Sik Lee, Soon Ho Um, Sang Woo Lee, Jai Hyun Choi, Chang Duk Kim, Ho Sang Ryu, Jin Hai Hyun Background: Polyethyleneglycol(PEG) is a widely used colon cleansing agent. It is an iso-osmotic electrolyte solution which induces diarrhea through electrochemical effect of sodium sulfate. The safety of PEG has been confirmed but due to large volume and salty and rotten taste, patients’ compliance can be reduced. On the other hand, sodium phosphate(NaP) is a hyperosmotic agent which induces diarrhea though osmotic effect. Since the volume is smaller, it can increase patients’ compliance. However, there have been concerns about electrolyte imbalance. Therefore, we conducted a study to see whether patients’ compliance can be enhanced and electrolyte imbalance reduced by combining these two agents. Patients and Methods: 41 patients who had colonoscopy while being admitted at Korea University Anam Hospital from June 28, 2004 to August 14, 2004, were randomly divided into two groups to do colon cleansing with either 4 L of PEG(n Z 21) or 2 L of PEG plus 45 mL of NaP(n Z 20). Patients were assessed on patient tolerance, quality of preparation, and changes of biochemical parameters. As for patient tolerance, fullness, nausea, vomiting, cramp, and overall discomfort were evaluated ranging from none, mild, bothersome, distressing, and severely distressing. Quality of preparation was evaluated using Aronchick scoring scale. Na, K, Cl, P, Ca, Mg, and Osm were measured before and after the colon cleansing to evaluate the electrolyte changes. Results: There were no statistical differences among patients’ baseline characteristics. Overall discomfort was statistically lower in the combination group(p Z 0.035). Although patients in the combination group reported less fullness (p Z 0.076) and nausea (p Z 0.087), it was not statistically significant. Quality of preparation was comparable between the two groups (p Z 0.872) with most of the patients showing excellent or good preparation. The phosphorus level showed statistically significant increase (0.58¡3/40.46) compared to the PEG group after colon cleansing (p Z 0.020) but not to the range for it to be clinically significant. The changes of the other biochemical markers were insignificant. Conclusion: The combination of NaP 45 mL and PEG 2 L showed less overall discomfort with comparable quality of preparation and without serious electrolyte abnormality compared to 4 L of PEG. Therefore, the combination could be used as an alternative colonoscopic colon cleansing agent when patients have trouble taking 4 L of PEG alone
W1079 Appropriate Utilization of Adjuvant Therapy Following Colorectal Cancer Diagnosis Neena S. Abraham, Jennifer Kramer, Travis Gossey, Jessica Davila Background: Adjuvant chemotherapy and or radiotherapy in patients with stage II/ III colorectal cancer can reduce the risk of local recurrence and prevent systemic involvement. Data suggest less than 50% of eligible patients receive adjuvant therapy at non-VA facilities. Our aim was to: 1) ascertain if underutilization of adjuvant therapies exist, and 2) assess determinants of this utilization. Methods: We conducted a retrospective cohort study at the Michael E. DeBakey Veteran’s Affairs Medical Center (MEDVAMC). Administrative data identified all patients with a diagnostic code for colorectal cancer (1999-2003). The medical chart of eligible patients was then abstracted to identify an incident cohort with stage II or III colorectal cancer. Our outcome of interest was the utilization of adjuvant chemo or radiotherapy, as defined by the National Cancer Institute. Logistic regression examined potential patient and provider determinants of receipt of adjuvant therapy. Results: One hundred and ninety seven incident cases were diagnosed or received treatment at the MEDVAMC. The mean age of the population was 66 years (SD 11 yrs), 64% were Caucasian and 98.5% were male. A gastroenterologist diagnosed the majority of tumors (72.5%). There were 62 stage II colon cancers; 62 stage III colon cancers; and 73 stage II/III rectal cancers. Referral to oncology was observed in 76% of stage II colon, 92% of stage III colon, and 99% of rectal cancers. 87% of stage II and 71% of stage III colon cancer patients received adjuvant therapy. However, among rectal cancer patients, only 42.5% received appropriate adjuvant therapy. Among 57.5% eligible rectal cancer patients, 36% were poor medical candidates, 15% declined therapy, 18% had their physician deem adjuvant therapy unnecessary, and 32% died prior to follow-up or experienced postoperative complications. Among rectal cancer patients predictors of adjuvant therapy included being married (OR 3.5; 95% CI: 1.3-9.4), presentation at tumor board (OR 2.4; 95% CI: 1.4-10.5) or age less than 65 years (OR 3.5; 95% CI: 1.3-9.3). Conclusions: A substantial proportion of colon cancer patients at a major VA medical center are receiving appropriate adjuvant therapy. Underutilization of adjuvant therapy among rectal cancer patients was observed. Younger or married rectal cancer patients and those presented at tumor board are most likely to receive adjuvant therapy.
Volume 61, No. 5 : 2005 GASTROINTESTINAL ENDOSCOPY AB245