A novel blood-sensing capsule for rapid detection of upper GI bleeding: a prospective clinical trial.

BACKGROUND AND AIMS: Upper GI bleeding (UGIB) is a common medical emergency associated with high resource utilization, morbidity, and mortality. Timely EGD can be challenging from personnel, resource, and access perspectives. PillSense (EnteraSense Ltd, Galway, Ireland) is a novel swallowed bleeding sensor for the detection of UGIB, anticipated to aid in patient triage and guide clinical decision-making for individuals with suspected UGIB. METHODS: This prospective, open-label, single-arm comparative clinical trial of a novel bleeding sensor for patients with suspected UGIB was performed at a tertiary care center. The PillSense system consists of an optical sensor and an external receiver that processes and displays data from the capsule as "Blood Detected" or "No Blood Detected." Patients underwent EGD within 4 hours of capsule administration; participants were followed up for 21 days to confirm capsule passage. RESULTS: A total of 126 patients were accrued to the study (59.5% male; mean age, 62.4 ± 14.3 years). Sensitivity and specificity for detecting the presence of blood were 92.9% (P = .02) and 90.6% (P < .001), respectively. The capsule's positive and negative predictive values were 74.3% and 97.8%, and positive and negative likelihood ratios were 9.9 and .08. No adverse events or deaths occurred related to the PillSense system, and all capsules were excreted from patients on follow-up. CONCLUSIONS: The PillSense system is safe and effective for detecting the presence of blood in patients evaluated for UGIB before upper GI endoscopy. It is a rapidly deployed tool, with easy-to-interpret results that will affect the diagnosis and triage of patients with suspected UGIB. (Clinical trial registration number: NCT05385224.).

Acute Esophageal Necrosis: A Retrospective Cohort Study Highlighting the Mayo Clinic Experience.

OBJECTIVE: To describe the clinical, endoscopic, and histologic features in patients with acute esophageal necrosis (AEN). PATIENTS AND METHODS: In this retrospective cohort study, patients who were diagnosed as having AEN at Mayo Clinic sites in Minnesota, Florida, and Arizona between January 1, 1996, and January 31, 2021, were included. Data were collected on patient clinical characteristics and endoscopic and pathologic findings. RESULTS: The study included 79 patients with AEN with a median (range) age of 64 years (12 to 91 years); 53 (67.1%) were men. Predominant presenting symptoms were hematemesis (49 of 79 [62.0%]), abdominal pain (29 [36.7%]), and melena (20 [25.3%]). Shock was the triggering event for AEN in 49 (62.0%). The 30- and 90-day mortality were 24.0% (19 of 79) and 31.6% (25), respectively. The presence of coexisting infection or bacteremia was significantly associated with 90-day mortality (P<.01). Endoscopically, involvement of the distal third only, distal two-thirds only, and entire esophagus was observed in 31.6% (24 of 76), 39.5% (30), and 29.0% (22), respectively. The length of esophageal involvement correlated with duration of hospitalization (P=.05). The endoscopic appearance of the esophageal mucosa ranged from predominantly white (21 of 44 [47.7%]) to mixed white and black (13 [29.6%]) to predominantly black (10 [22.7%]), and sloughing was present in 18 (40.9%). In the 26 patients with histopathologic findings available for review, 25 (96.1%) had necrosis and/or ulceration with abundant pigmentation. Among the 79 patients, 39 (49.4%) had a follow-up esophagogastroduodenoscopy; 26 of these 39 patients (66.7%) had resolution while 5 had persistent AEN, 4 of whom had improvement. Esophageal strictures developed in 7 of the 39 patients (18.0%). CONCLUSION: Acute esophageal necrosis is a serious condition observed in critically ill patients. Its endoscopic appearance can be highly variable. In patients with an unclear diagnosis, esophageal biopsies may be helpful given the characteristic histologic findings.

Collaborative improvement on acute opioid prescribing among diverse health systems.

BACKGROUND: Despite broad awareness of the opioid epidemic and the understanding that patients require much fewer opioids than traditionally prescribed, improvement efforts to decrease prescribing have only produced modest advances in recent years. METHODS AND FINDINGS: By using a collaborative model for shared expertise and accountability, nine diverse health care systems completed quality improvement projects together over the course of one year to reduce opioid prescriptions for acute pain. The collaborative approach was flexible to each individual system's goals, and seven of the nine participant institutions definitively achieved their desired results. CONCLUSIONS: This report demonstrates the utility of a collaborative model of improvement to bring about real change in opioid prescribing practices and may inform quality improvement efforts at other institutions.

Randomized Phase II Trial of Polyphenon E versus Placebo in Patients at High Risk of Recurrent Colonic Neoplasia.

Polyphenon E (Poly E) is a green tea polyphenol preparation whose most active component is epigallocatechin gallate (EGCG). We studied the cancer preventive efficacy and safety of Poly E in subjects with rectal aberrant crypt foci (ACF), which represent putative precursors of colorectal cancers. Eligible subjects had prior colorectal advanced adenomas or cancers, and had ≥5 rectal ACF at a preregistration chromoendoscopy. Subjects (N = 39) were randomized to 6 months of oral Poly E (780 mg EGCG) daily or placebo. Baseline characteristics were similar by treatment arm (all P >0.41); 32 of 39 (82%) subjects completed 6 months of treatment. The primary endpoint was percent reduction in rectal ACF at chromoendoscopy comparing before and after treatment. Among 32 subjects (15 Poly E, 17 placebo), percent change in rectal ACF number (baseline vs. 6 months) did not differ significantly between study arms (3.7% difference of means; P = 0.28); total ACF burden was also similar (-2.3% difference of means; P = 0.83). Adenoma recurrence rates at 6 months were similar by arm (P > 0.35). Total drug received did not differ significantly by study arm; 31 (79%) subjects received ≥70% of prescribed Poly E. Poly E was well tolerated and adverse events (AE) did not differ significantly by arm. One subject on placebo had two grade 3 AEs; one subject had grade 2 hepatic transaminase elevations attributed to treatment. In conclusion, Poly E for 6 months did not significantly reduce rectal ACF number relative to placebo. Poly E was well tolerated and without significant toxicity at the dose studied. PREVENTION RELEVANCE: We report a chemoprevention trial of polyphenon E in subjects at high risk of colorectal cancer. The results show that polyphenon E was well tolerated, but did not significantly reduce the number of rectal aberrant crypt foci, a surrogate endpoint biomarker of colorectal cancer.

Evaluating a combined bowel preparation for small-bowel capsule endoscopy: a prospective randomized-controlled study.

BACKGROUND: Capsule endoscopy (CE) is frequently hindered by intra-luminal debris. Our aim was to determine whether a combination bowel preparation would improve small-bowel visualization, diagnostic yield, and the completion rate of CE. METHODS: Single-blind, prospective randomized-controlled study of outpatients scheduled for CE. Bowel-preparation subjects ingested 2 L of polyethylene glycol solution the night prior to CE, 5 mL simethicone and 5 mg metoclopramide 20 minutes prior to CE and laid in the right lateral position 30 minutes after swallowing CE. Controls had no solid food after 7 p.m. the night prior to CE and no liquids 4 hours prior to CE. Participants completed a satisfaction survey. Capsule readers completed a small-bowel-visualization assessment. RESULTS: Fifty patients were prospectively enrolled (56% female) with a median age of 54.4 years and 44 completed the study (23 patients in the control group and 21 in the preparation group). There was no significant difference between groups on quartile-based small-bowel visualization (all P > 0.05). There was no significant difference between groups in diagnostic yield (P = 0.69), mean gastric (P = 0.10) or small-bowel transit time (P = 0.89). The small-bowel completion rate was significantly higher in the preparation group (100% vs 78%; P = 0.02). Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%; P = 0.01). CONCLUSIONS: Combined bowel preparation did not improve small-bowel visualization but did significantly increase patient discomfort. The CE completion rate improved in the preparation group but the diagnostic yield was unaffected. Based on our findings, a bowel preparation prior to CE does not appear to improve CE performance and results in decreased patient satisfaction (ClinicalTrials.gov, No. NCT01243736).

Efficacy of Difluoromethylornithine and Aspirin for Treatment of Adenomas and Aberrant Crypt Foci in Patients with Prior Advanced Colorectal Neoplasms.

Difluoromethylornithine (DFMO), an inhibitor of polyamine synthesis, was shown to act synergistically with a NSAID for chemoprevention of colorectal neoplasia. We determined the efficacy and safety of DFMO plus aspirin for prevention of colorectal adenomas and regression of rectal aberrant crypt foci (ACF) in patients with prior advanced adenomas or cancer. A double-blinded, placebo-controlled trial was performed in 104 subjects (age 46-83) randomized (1:1) to receive daily DFMO (500 mg orally) plus aspirin (325 mg) or matched placebos for one year. All polyps were removed at baseline. Adenoma number (primary endpoint) and rectal ACF (index cluster and total) were evaluated at a one year colonoscopy. ACF were identified by chromoendoscopy. Toxicity was monitored, including audiometry. Eighty-seven subjects were evaluable for adenomas or ACF modulation (n = 62). At one year of treatment, adenomas were detected in 16 (38.1%) subjects in the DFMO plus aspirin arm (n = 42) versus 18 (40.9%) in the placebo arm (n = 44; P = 0.790); advanced adenomas were similar (n = 3/arm). DFMO plus aspirin was associated with a statistically significant reduction in the median number of rectal ACF compared with placebo (P = 0.036). Total rectal ACF burden was also reduced in the treatment versus the placebo arm relative to baseline (74% vs. 45%, P = 0.020). No increase in adverse events, including ototoxicity, was observed in the treatment versus placebo arms. While adenoma recurrence was not significantly reduced by one year of DFMO plus aspirin, the drug combination significantly reduced rectal ACF number consistent with a chemopreventive effect.

Patient-oriented education and visual-aid intervention are inadequate to identify patients with potential capsule retention: a prospective randomized study.

Background/aims: The key procedure-related risk with video capsule endoscopy (VCE) is capsule retention, which should be suspected in patients who have not reported capsule passage. The study aims were to determine the frequency of capsule passage visualization and the difference in self-reporting of capsule passage between patients who receive patient-oriented education (POE) and patients who receive POE and a visual aid intervention in the form of a wrist band (WB). Methods: This was a prospective randomized study that enrolled patients undergoing VCE. Patients were randomly assigned to a POE group versus a POE and WB group. POE consisted of verbal education and an information booklet. Both groups received instructions to notify the study team regarding capsule passage. Results: Sixty patients (mean age 57 ± 18 years; 61% female) were included. A total of 57 patients were included in the analysis (3 lost to follow-up; 28 in POE group; 29 in WB group). Capsule passage status was reported by 68% without significant difference between POE and WB groups (72% vs. 64%; p = .51). Capsule passage status was obtained from all 57 patients with the addition of a proactive follow-up. Only 56% (n = 32) reported visualizing capsule passage. Of the remaining patients who did not visualize capsule passage, 60% (n = 15) reported on this without significant difference between the POE and WB groups (p = .23). Conclusions: Lack of visualization of capsule passage is a poor indicator of retention. Self-reporting of VCE passage status is suboptimal and the addition of a visual aid did not improve this parameter.

A Collaborative for Implementation of an Evidence-Based Clinical Pathway for Enhanced Recovery in Colon and Rectal Surgery in an Affiliated Network of Healthcare Organizations.

BACKGROUND: In 2015 the Mayo Clinic Care Network (MCCN), in an effort to extend medical knowledge and share these best practices, embarked on an education mission to diffuse the clinical practice redesign involving the practice of colon and rectal surgery at Mayo Clinic (Rochester, Minnesota) to members of the MCCN. They elected to use a collaborative framework in an attempt to transfer knowledge to multiple teams in an efficient and supportive manner. METHODS: Eight MCCN members assembled a multidisciplinary team, which participated in both a didactic learning session delivered by frontline experts, as well as follow-up remote sessions regarding Mayo Clinic's enhanced recovery pathway for colon and rectal surgery. Teams departed the group session with established immediate next steps, communication plans, and an awareness of potential barriers and strategies for mitigation. Monthly coaching calls followed in an effort to help all teams meet their time line and overall goals. Finally, all participants met again after six months to report their clinical outcomes, as well their unique individual organization's successes and barriers encountered. RESULTS: Participating teams felt overwhelmingly that the collaborative program exceeded their expectations and equipped them with the tools to be successful. They also felt that the extended support provided by the Mayo Clinic team was essential, and the collaboration with other members markedly enhanced their experience. Importantly, all teams were able to successfully reduce length of stay, which was the desired main clinical outcome. DISCUSSION: The collaborative format was instrumental in the rapid diffusion and successful implementation of a transformative practice redesign involving colorectal surgical care of patients.

Outcomes of endoscopic intervention for overt GI bleeding in severe thrombocytopenia.

BACKGROUND AND AIMS: Gastrointestinal bleeding (GIB) in the setting of thrombocytopenia raises concerns about endoscopic procedure risk. We aimed to assess the safety and outcomes of endoscopy for overt GIB in the setting of severe thrombocytopenia in liver cirrhosis (LC) and non-liver cirrhosis (NLC). METHODS: This is a retrospective study on inpatients who underwent endoscopy within 24 hours of presentation for overt GIB with a platelet count (PC) of 20 to <50 × 103/mL. Outcomes included diagnostic and therapeutic yields, procedural adverse events, packed red blood cell (pRBC) and platelet transfusions, recurrent bleeding rate, and all-cause and GIB-related mortality. RESULTS: One hundred forty-four patients were identified. The median PC was 41 × 103/mL and 61% had LC. The diagnostic yield was 68% (LC = 61%, NLC = 79%, P = .04). Therapeutic yield was 60% (59% vs 60%, P = 1.00). The initial hemostasis rate was 94% with one adverse event. The median number of pRBC and platelet transfusions decreased after intervention in the entire cohort. Recurrent bleeding rates were 22% at 1 month and 30% at 1 year, with no differences between groups. An increased international normalized ratio (INR) >2 was a predictor of recurrent bleeding. All-cause mortality was 19% at 1 month and 37% at 1 year, whereas GIB-associated mortality in our cohort was only 3% at 1 month and 4% at 1 year, with no significant difference between LC and NLC. Predictors of mortality were INR >2, activated partial thromboplastin time >38 seconds, hypotension, intensive care unit admission, and pulmonary comorbidities. CONCLUSION: In this study cohort, we observed that endoscopy for overt GIB in the setting of severe thrombocytopenia in patients with LC and NLC appears safe, has moderate diagnostic and therapeutic yields with high initial hemostasis rate, and is associated with a significant decrease in pRBC and platelet transfusions. Recurrent bleeding and all-cause mortality rates remain high.

Overall Cost Comparison of Gastrointestinal Endoscopic Procedures With Endoscopist- or Anesthesia-Supported Sedation by Activity-Based Costing Techniques.

OBJECTIVE: Endoscopic/colonoscopic procedures are either done with gastroenterologist-administered conscious sedation or with anesthesia-administered sedation with propofol. There are potential benefits to anesthesia-administered sedation, but the concern has been the associated increased cost. METHODS: To perform this study, we used the time-derived activity-based costing (TDABC) technique to accurately assess the true cost of gastrointestinal procedures done with gastroenterologist-administered conscious sedation vs anesthesia-administered sedation in 2 areas of our practice that use predominantly conscious sedation or anesthesia-administered sedation. This type of study has never been reported using such an integrated approach. This study was performed on 2 different days in June 2015. RESULTS: The true cost associated with anesthesia-administered sedation in our practice was associated with only 9% to 24% greater cost when the TDABC technique was applied. CONCLUSION: Gastrointestinal procedures with anesthesia-administered sedation are not as costly when all factors are considered. Using novel approaches to cost measurement, such as the TDABC, allows a total cost measurement approach across an episode of care that existing cost measurements in health care are incapable of.

Cross-Site Scheduling of Endoscopic Procedures Improves Efficiency While Maintaining Patient Safety.

BACKGROUND AND AIM: Accuracy in scheduling complex procedures is improved through technology to aid nonmedically trained allied health professionals. We used a new computer technology to assess whether a single coordinator could schedule endoscopic procedures across sites of a multisite academic medical institution, thus improving efficiency within the clinic overall. METHODS: A multidisciplinary team designed a cross-site scheduling model. The first phase involved accurately identifying those procedures that were appropriate for nontrained coordinators to schedule. A pilot study with gastroenterology staff was implemented and evaluated and then rolled out to non-gastroenterology staff. RESULTS: A significant decrease in call volumes occurred which in turn led to a decrease from >100 to 38 seconds in average speed to answer (ASA). A total of 115 hours of manpower was saved with the efficiency of being able to schedule without the need for a second coordinator. CONCLUSIONS: Efficiencies in call volume and ASA led to substantial time and money savings. Because of the continued involvement of multiple work groups, changes were seen as favorable rather than burdensome. Such technology could be used across other disciplines where routine procedures or tests require specific scheduling knowledge.

Training in small-bowel capsule endoscopy: assessing and defining competency.

BACKGROUND: Minimum training for capsule endoscopy (CE) is based on societal guidelines and expert opinion. Objective measures of competence are lacking. OBJECTIVES: Our objectives were to (1) establish structured CE training curriculum during a gastroenterology fellowship, (2) develop a formalized assessment tool to evaluate CE competency, (3) prospectively analyze trainee CE competency, (4) define metrics for trainee CE competence by using comparative data from CE staff, and (5) determine the correlation between CE competence and previous endoscopy experience. DESIGN: Single-center, prospective analysis over 6 years. SETTING: Tertiary academic center. SUBJECTS: Gastroenterology fellows and CE staff. INTERVENTIONS: Structured CE training was implemented with supervised CE interpretation. Capsule Competency Test (CapCT) was developed and data were collected on the number of CEs, upper endoscopies, colonoscopies, and push enteroscopies performed. MAIN OUTCOME MEASUREMENTS: Trainee competence defined as CapCT score 90% or higher of the mean staff score. RESULTS: A total of 39 fellows completed CE training and CapCT. Fellows were grouped according to number of completed CE interpretations: 10 or fewer (n = 13), 11 to 20 (n = 19), and 21 to 35 (n = 7). Eight CE staff completed CapCT with a mean score of 91%. Mean scores for trainees with fewer than 10, 11 to 20, and 21 to 35 CE interpretations were 79%, 79%, and 85%, respectively. A significant difference was seen between staff and fellow scores with 10 or fewer and 11 to 20 interpretations (P < .001). No correlation was found between trainee scores and previous endoscopy experience. LIMITATIONS: Single center. CONCLUSION: Using a structured CE training curriculum, we defined competency in CE interpretation by using the CapCT. Based on these findings, trainees should complete more than 20 CE studies before assessing competence, regardless of previous endoscopy experience.

Quality improvement project eliminates falls in recovery area of high volume endoscopy unit.

BACKGROUND: The authors' high-volume gastrointestinal endoscopy unit developed an infrastructure to track complications associated with endoscopic procedures in January of 2008. A result of this effort was the identification of a surprising number of patient falls in their recovery area. In response to this finding, the authors created and implemented a quality improvement project to eliminate patient falls in the endoscopy recovery area. METHODS: The authors analysed each patient fall to try to identify the root cause in each case, and found that most falls occurred in patients of advanced age or who ambulated with an assistive device and fell while changing clothes in the bathroom unaccompanied. The authors initiated a quality improvement project to identify patients at risk of falling and to make changes in the recovery room process to minimise their risk of falling. Any patient identified as a fall risk would then be accompanied to the bathroom to change by one of the allied health staff, and they would leave the recovery area in a wheelchair. The authors used descriptive statistics to analyse age, gender, use of an assistive ambulatory device and total number of endoscopic procedures. The authors used the Fisher exact test to compare the proportion of procedures that were complicated by patient falls before and after the quality improvement intervention. RESULTS: In 2008, the authors completed 38370 sedated endoscopic procedures and had eight patient falls (0.02%). Three patients were female, and the mean age was 67 (range 40-96). Five of the eight patients who fell were over the age of 70 and/or used an assistive device for ambulation. All patients sustained injuries that required additional medical attention. The authors' fall prevention initiative started on 23 January 2009. From 23 January 2009 to 23 January 2010, the unit completed 42845 sedated endoscopic procedures and had no patient falls in the endoscopic unit (p=0.002). CONCLUSIONS: These data demonstrate that a simple, low-cost intervention in a high-volume endoscopy centre can completely eliminate patient falls.

Endoscopic management of radiation-induced complete upper esophageal obstruction with an antegrade-retrograde rendezvous technique.

BACKGROUND: Esophageal strictures occur in 3% to 4% of patients with head and neck cancer who undergo radiation therapy. Some patients develop complete obstruction of the upper esophagus. Antegrade dilatation is often unsuccessful and many of these patients require surgery. OBJECTIVE: To describe the outcomes and complications of an endoscopic antegrade-retrograde rendezvous procedure to restore esophageal patency. DESIGN: Retrospective review of 8 cases treated with an endoscopic rendezvous procedure between August 2001 and April 2005. Medical records of consenting patients were abstracted for clinical history, procedural success, complications, and follow-up. SETTING: A large tertiary referral center. PATIENTS: Eight patients with head and neck or upper esophageal cancer and complete upper esophageal obstruction from radiation stricturing who underwent an attempted rendezvous procedure. MAIN OUTCOME MEASUREMENTS: Clinical procedural success, reported adverse events. RESULTS: Seven patients were men, and median age was 65 years. The median interval between radiation and the rendezvous procedure was 11 months. In 7 of 8 cases esophageal patency was restored and no major complications occurred. Two esophageal microperforations resolved without intervention. Most patients responded well to subsequent serial dilations and many discontinued gastrostomy tube use. LIMITATIONS: Retrospective, selection bias. CONCLUSIONS: An antegrade-retrograde rendezvous technique with subsequent dilation appears to be safe and effective for endoscopic management of complete upper esophageal obstruction induced by radiotherapy and can obviate the need for esophageal resection.

Incident rates of colonic neoplasia in older patients: when should we stop screening?

INTRODUCTION: Current guidelines endorse colon cancer screening every 5-10 years in patients over 50 years of age. However, there is no consensus regarding what age is appropriate to stop screening. The aim of this study was to characterize neoplasia occurrence/recurrence in a large cohort of patients > or =70 years of age undergoing colonoscopy. METHODS: The Mayo Rochester endoscopic database was reviewed to determine the incidence of colonic neoplasia in patients > or =70 years undergoing two colonoscopies at least 12 months apart between January 1996 and December 2000. Patients were classified based on (i) age: 70-74, 75-79, > or =80 years; and (ii) polyp detection on initial examination, that is, subsequent examination for screening or surveillance. RESULTS: Overall, 1353 patients underwent two colonoscopies at least 12 months apart (median interval 140 weeks) with removal of polyp on initial examination in 726 (53.7%) patients (surveillance cohort). On subsequent endoscopy, polyps > or =10 mm were detected in 54 (4.0%) and cancer in 13 (1.0%) patients. All age groups were well matched with respect to detection of neoplasia on index examination (P = 0.9) and polyp size on initial colonoscopy among the surveillance group (P = 0.9). Using a Cox proportional hazards model, adjusted hazard ratios (95% confidence interval [CI]) for neoplasia (polyps > or =10 mm) were: 2.0 (1.50-2.73, P < 0.0001) (surveillance vs screening), 1.33 (0.96-1.79, P = 0.08) (> or =80 vs 70-74), and 1.05 (0.78-1.38, P = 0.75) (75-79 vs 70-74). Adjusted hazard ratios for development of cancer were: 1.87 (1.03-3.97, P = 0.04) (surveillance vs screening), 1.73 (0.84-3.56, P = 0.13) (> or =80 vs 70-74), and 1.38 (0.71-2.77, P = 0.34) (75-79 vs 70-74). CONCLUSIONS: Prior history of neoplasia remains a strong risk factor for colorectal neoplasia development in elderly patients and should be considered when deciding the need for continuing screening/surveillance. Incident neoplasia rates in a previously screened elderly population rise slowly with advancing age although cancer rates rise more sharply. Therefore, screening still retains a role in elderly patients; however, clinical judgment is still required to individualize screening practice. As the risk of competing comorbid illnesses continues to increase over time, the threshold to perform colon screening should increase accordingly.

Colonoscopy as a screening test for colorectal cancer in average-risk individuals.

Screening for colorectal cancer has become the standard of care and is currently recommended by most major health organizations, including the American Cancer Society. Randomized controlled trials using fecal occult blood testing as the screening strategy have shown a reduction in mortality due to colorectal cancer. However, colorectal cancer differs from other cancers in that a variety of screening tests have been approved and recommended by experts. The advantages and disadvantages of different screening tests have been the subject of intense debate. Colonoscopy has theoretical advantages over other screening tests, including direct visualization of the entire colon and, more importantly, removal of precancerous adenomatous lesions. This review discusses the advantages and disadvantages of colonoscopy as a screening test for colorectal cancer with regard to efficacy, cost-effectiveness, and patient compliance.