Evaluation of a novel endoluminal stapling procedure to restrict the lower esophageal sphincter and reduce reflux.

BACKGROUND AND STUDY AIMS: An effective, safe, and long-lasting endoluminal treatment for gastroesophageal reflux disease (GERD) would be an attractive prospect. We developed an endoluminal technique to restrict and tighten the lower esophageal sphincter (LES), by using a transoral endoscopic stapling device in a porcine model. PATIENTS AND METHODS: Pre-interventional evaluation comprised endoscopy, manometry, and 48-hour pH measurement of the distal esophagus using the catheterless BRAVO pH capsule. By placing the endoluminal stapling device at the LES and firing a 2.5-cm staple line, a vertical plication was created. In five pilot pigs (phase 1), plications were placed in various locations at the LES. In another five pigs (phase 2), plications were placed uniformly at the mid level of the LES on the lesser curvature side. Measurements were repeated 2 weeks after the procedure. Necropsy and histological analysis were performed. RESULTS: Endoluminal stapling was successfully completed in all animals. In phase 2, the median procedure time was 15 minutes (range 10-55 minutes). LES pressure increased from 10.5 mmHg (+/- 2.5 mmHg) to 14.3 mmHg (+/- 3.8 mmHg) (P = 0.038). Median percentage of time with pH below 4 decreased from 6.6% (range 2.9%-48.8%) to 2.2% (range 0%-10.4%) (P = 0.043). Histology showed the staple line involving the muscular layer in all pigs. A gap was present in the central part of the staple line in three pigs resulting in a mucosa-muscular bridge of tissue. This bridge did not influence the results. CONCLUSION: This novel endoluminal technique is feasible and safe in a porcine model over 2 weeks. It is appealing due to its simplicity and ease of application. Further studies aimed at eliminating the gap in the staple line and investigating more animals over longer survival periods are needed.

Is the variable-stiffness paediatric colonoscope more effective than a standard adult colonoscope for outpatient adult colonoscopy? A randomised controlled trial.

BACKGROUND: Trials with variable-stiffness colonoscopes have yielded conflicting results regarding efficacy and patient tolerance. AIM: We compared a variable-stiffness paediatric colonoscope with a standard adult colonoscope. METHODS: Two hundred and forty consecutive adult outpatients presenting for colonoscopy were randomised to either a variable-stiffness paediatric colonoscope or an adult colonoscope. If there was difficulty in performing colonoscopy with the assigned scope, the endoscopist was given the option of switching to the alternative instrument. In the condition of a severely fixed, angulated sigmoid colon, a final 'salvage' (backup) option was that of switching to an even thinner diameter paediatric colonoscope. RESULTS: The initial frequency of total colonoscopy was similar with the variable-stiffness paediatric colonoscope and adult colonoscope (95.8% versus 96.6%, p=1.0). Factoring in scope changes, the final frequency was 98.3% versus 99.2% (p=1.0). There was no statistical difference between the two groups in terms of insertion time, doses of sedative medications, scales of procedure difficulty, or patient satisfaction. CONCLUSIONS: Adult colonoscope and variable-stiffness paediatric colonoscope are both effective instruments for routine colonoscopy. In cases when the use of the initial scope is unsuccessful, switching to the alternative scope may permit passage to the caecum. There are occasional patients with fixed, angulated sigmoid colons in whom use of an even thinner diameter paediatric colonoscope can be helpful.

Usefulness of a pediatric colonoscope for colonoscopy in adults.

BACKGROUND: There are few published data on how different types of colonoscopes affect success in reaching the cecum and patient comfort. We examined the feasibility of using a pediatric colonoscope for routine colonoscopy in adults and investigated whether there were subgroups of patients in whom use of this instrument was preferable. METHODS: One-hundred fifty adults undergoing outpatient colonoscopy were randomized to colonoscopy with a standard colonoscope (Olympus CF-100L) or with a pediatric colonoscope (Olympus PCF-100). All procedures were performed by a faculty endoscopist and timed by an independent observer. After examinations, the endoscopist graded procedure difficulty and patients were given a questionnaire that assessed their experience. RESULTS: The adult (n = 77) and pediatric (n = 73) colonoscope groups were comparable in all outcomes measured, including success in reaching the cecum (91% vs. 93%, p = 0.61), mean time to reach the cecum (11.4 vs. 9.7 min, p = 0.07), mean total procedure time (21.8 vs. 21.9 min, p = 0.95), mean meperidine dose (55 vs. 52 mg, p = 0.17); median midazolam dose (2.0 mg in both groups, p = 0.10), the endoscopists' perception of procedure difficulty, and patient comfort scales. Of the 7 patients in whom colonoscopy with the adult colonoscope was unsuccessful, the cecum was reached in 4 by switching to a pediatric colonoscope (all women, 3 of whom had prior hysterectomy). In the 5 patients in whom colonoscopy with the pediatric colonoscope was unsuccessful, the cecum was reached in 1 by switching to an adult colonoscope. Including the cases in which the cecum was reached by switching to the alternative colonoscope, the overall frequency of cecal intubation was 143 of 150 (95%). Subgroup analysis disclosed no difference between the 2 groups in outcomes when gender, presence of diverticulosis, and patient size were considered. Colonoscopy with the pediatric colonoscope was more successful than with the adult instrument in reaching the cecum in women with prior hysterectomy (11 of 12 [92%] vs. 15 of 21 [71%]); however, the numbers in each group were relatively small and the difference was not significant (p = 0.22). CONCLUSIONS: The pediatric colonoscope is suitable for routine colonoscopy in adults. It is also useful in patients in whom colonoscopy with the adult colonoscope is unsuccessful in reaching the cecum (particularly in women). Additional study is needed to see if the pediatric colonoscope is actually superior to the adult colonoscopy for routine colonoscopy in women with prior hysterectomy.

Percutaneous cholecystostomy is an effective treatment for high-risk patients with acute cholecystitis.

We sought to determine the safety, efficacy, and outcome of percutaneous cholecystostomy (PC) in all patients undergoing the procedure at our institutions. We reviewed 53 consecutive cases of acute cholecystitis seen at our hospitals over 5.5 years in which PC was performed at the initial treatment. Follow-up was obtained by chart review and telephone questionnaire. Acute cholecystitis was the primary admitting diagnosis in 18 cases. In the remaining 35, cholecystitis developed during hospitalization. All patients were considered high surgical risks on the basis of the presence of comorbid conditions. The gallbladder was successfully catheterized under radiologic guidance in all patients and with no immediate procedure-related morbidity. Acute cholecystitis resolved in 44 of 53 patients (83%), whereas nine patients (17%) did not improve clinically after PC and died during the same hospitalization. A total of 33 (62%) eventually survived hospitalization. Elective cholecystectomy was done in 25 patients with no mortality. After cholecystectomy, three of these patients subsequently died of other causes, whereas 22 are alive. Eight patients did not undergo cholecystectomy because of underlying medical conditions or because they had acalculous cholecystitis. These patients remained free of biliary problems after removal of their cholecystostomy tube, but two have subsequently died of nonbiliary conditions. Percutaneous cholecystostomy is a safe, effective treatment for high-risk patients with acute cholecystitis. Cholecystostomy can be followed by elective cholecystectomy at a later time if the patient's condition permits or by expectant conservative management in patients who have had acalculous cholecystitis or have a very high mortality risk with surgery.

High grade, synchronous colon cancers after renal transplantation: were immunosuppressive drugs to blame?

Recipients of renal transplants are known to have an increased incidence of cancer, which is believed to be related to the use of immunosuppressive drugs used to prevent rejection. Although the risks of lymphoma and Kaposi's sarcoma are clearly increased in this setting, the association with colon cancer is controversial. We report a 44-yr-old woman, 20 yr post-renal transplant, and with no family history of colorectal cancer or polyps, who was found to have synchronous, poorly differentiated colon cancers associated with extensive abdominal lymph node, bone marrow, and bone (skull) metastasis. The long term immunosuppressive drugs that she had received may have been an important factor in her tumor development and/or progression. Our case and literature review suggest a possible mild, increased risk of colon cancer development in patients after renal transplantation.

Patient attitudes toward undergoing colonoscopy without sedation.

OBJECTIVE: The vast majority of patients undergoing colonoscopy in the United States are given sedation. There are a number of potential advantages to performing colonoscopy without sedation. We sought to determine the attitude of patients toward unsedated colonoscopy in our three practice settings (a university medical center, a cancer center, and a Veterans Affairs medical center), and to see if there were factors that predicted willingness to try it. METHODS: Four-hundred thirty-four adult patients undergoing outpatient colonoscopy completed questionnaires before and after their procedures providing demographic information and assessing willingness to undergo colonoscopy without sedation. Patients were routinely given meperidine and midazolam for their procedures unless they specifically requested that they be unsedated (10 patients). RESULTS: Only 16.9% of our patients were willing to undergo colonoscopy on their preprocedure questionnaire. Willingness increased modestly on the postprocedure questionnaire to 22.6% (p = 0.01). Logistic regression analysis disclosed that male gender, having a college degree, low anxiety based on preprocedure anxiety scales, and lower doses of sedative drugs used during colonoscopy were the best predictors of willingness to undergo colonoscopy without sedation in the future. CONCLUSIONS: Only about a fifth of patients undergoing colonoscopy in our three practice settings expressed a willingness to try colonoscopy unsedated. Male gender, higher levels of education, and low anxiety scores on simple scales of preprocedure anxiety may help to predict willingness. Efforts to substantially increase the frequency of patients willing to undergo colonoscopy without sedation will likely require increased patient counseling and education.

Benefit of intravenous antispasmodic (hyoscyamine sulfate) as premedication for colonoscopy.

BACKGROUND: We sought to determine whether premedication for colonoscopy with intravenous hyoscyamine sulfate (Levsin) was helpful from the standpoint of the colonoscopist and the patient. METHODS: One hundred sixteen adult patients were randomized to receive either 0.5 mg hyoscyamine sulfate intravenous (n = 57) or placebo (n = 59). After administration of study drug, patients were given meperidine and midazolam. Parameters measured included the time required to reach the cecum, total procedure time, and the endoscopist's perception of the adequacy of sedation, difficulty of insertion, and amount of colonic spasm on insertion and withdrawal. Patients were given a postprocedure questionnaire assessing their experience. RESULTS: In patients receiving hyoscyamine, there was a shorter cecal intubation time (median 9.2 vs. 12.9 minutes; p = 0. 01), shorter total colonoscopy time (median 20.5 vs. 25.0 minutes; p = 0.01), better patient sedation (p = 0.02), easier colonic insertion (p = 0.001), and less spasm on insertion (p = 0.01). No difference was found in the amount of spasm during withdrawal or the total dosages of meperidine or midazolam used. Patients receiving hyoscyamine sulfate reported being more comfortable during their procedures ( p < 0.001) and were more willing to repeat colonoscopy in the future (p = 0.0001). The only adverse effect seen during the study was a 27% incidence of sinus tachycardia that occurred in patients receiving hyoscyamine. CONCLUSIONS: Premedication with intravenous hyoscyamine sulfate was beneficial in terms of the time required for cecal intubation, total procedure time, adequacy of sedation, and scales of patient comfort. However, the high frequency of sinus tachycardia seen with the dose used in our study, which was extremely rapid in two patients, indicates the need for further study before the drug can be recommended as a routine premedication for colonoscopy.

Intrasphincteric botulinum toxin type A for the diagnosis of sphincter of Oddi dysfunction: a case report.

Biliary-type pain from sphincter of Oddi dysfunction is not uncommon after cholecystectomy. An increased basal pressure of sphincter of Oddi manometry establishes the diagnosis and treatment is usually by endoscopic sphincterotomy. Both procedures carry a significant complication rate. A few patients with elevated sphincter pressure do not respond to therapy; the source of their pain may be elsewhere. This case report describes the use of intrasphincteric botulinum toxin injection for the diagnosis of sphincter of Oddi dysfunction in a patient after repeated attempts at manometry had failed. This may provide a safe and easy method of determining whether sphincter of Oddi dysfunction may be the cause of biliary pain in post/ cholecystectomy patients and help select patients who would benefit from subsequent sphincter ablation, without the risks of sphincter of Oddi manometry. Prospective studies are first needed.

Cholecystectomy alleviates acalculous biliary pain in patients with a reduced gallbladder ejection fraction.

BACKGROUND: We sought to determine whether a reduced gallbladder ejection fraction, (GBEF) ascertained by cholecystokinin-cholescintigraphy (CCK-CS), predicts symptomatic improvement after cholecystectomy. METHODS: Medical records of patients who had had CCK-CS as well as negative results of gallbladder ultrasonography were reviewed, and patients were contacted by telephone to determine whether they had benefited from cholecystectomy. RESULTS: There were 35 patients (33 female, 2 male) who had a decreased GBEF. Cholecystectomy was done in 30, of whom 20 (67%) had resolution of pain, 8 (27%) had partial improvement, and 2 (7%) had no change. The 5 who declined cholecystectomy included none (0%) who were pain free, 2 (40%) who had partial improvement, and 3 (60%) who had no change. The clinical outcome of the two groups was significantly different. There were 14 patients (10 female, 4 male) with a normal GBEF. The 2 patients who had cholecystectomy were asymptomatic. Of the 12 patients who did not have cholecystectomy, 9 (75%) were asymptomatic, 1 (8%) had some improvement, and 2 (17%) had no change. CONCLUSIONS: Cholecystectomy is indicated for patients with acalculous biliary pain and reduced GBEF, since symptoms will likely resolve with surgery and will persist without it. Cholecystectomy for patients with a normal GBEF should be considered only after failure of a nonoperative trial, since improvement usually occurs over time.

Gastric Crohn's disease complicated by adenocarcinoma of the stomach: case report and review of the literature.

Patients with Crohn's disease are at increased risk for developing adenocarcinoma of the small bowel and colon. Although several cases of gastric malignancy have been reported in patients with Crohn's disease, the association remains controversial, particularly because most patients have not had gastric Crohn's involvement. We report a patient with long-standing Crohn's disease, with gastric involvement, who developed adenocarcinoma of the gastric outlet. We discuss the association and include a review of the literature.

Prevalence of open-access gastrointestinal endoscopy in the United States.

OBJECTIVE: Open-access endoscopy allows physicians who are not gastroenterologists to directly schedule patients for endoscopic procedures without having them first seen in the gastrointestinal clinic. We sought to determine the prevalence of open-access endoscopy in the United States and to examine endoscopists' attitudes toward the practice. METHODS: Questionnaires were mailed to a random sample of 1500 members of the American Society for Gastrointestinal Endoscopy. Out of 1460 that apparently reached the endoscopist, 577 (39.5%) were returned and analyzed. RESULTS: Of the endoscopists who responded, 60.5% said that they offered some form of open-access endoscopy. Open-access endoscopy comprised less than 10% of outpatient endoscopic practice for 48.2% of individuals who reported they offered the service; it comprised over 25% of practice in 19.8%. Of those doing it, the procedures offered on an open-access basis included esophagogastroduodenoscopy 86.0%, colonoscopy 76.5%, flexible sigmoidoscopy 94.3%, ERCP 7.7%, and endoscopic ultrasonography 4.3%. For endoscopists not offering open-access endoscopy, the most important reasons were concern about performing "not indicated" procedures (85.1 %), medical-legal issues (65.8%), and failure to believe in the concept of open-access endoscopy (59.6%). Attitudes toward open access endoscopy were significantly different among endoscopists who did and did not practice it. CONCLUSIONS: Open-access endoscopy, offered by more than 60% of the American endoscopists who responded to our survey, has become an important method of health care delivery in this country.

Is routine screening for colorectal cancer justifiable? These gastroenterologists say YES!

While methods of screening for colorectal cancer undoubtedly will be refined and new techniques developed, there is ample evidence to support use of the currently employed protocol: annual fecal occult blood testing and periodic flexible sigmoidoscopy. Aggressive attempts to educate physicians and patients on the importance of such screening are needed. Primary care physicians can play an important role in ensuring patient compliance and reducing the incidence of this serious public health problem.

Predictors of patient cooperation during gastrointestinal endoscopy.

We examined a number of patient variables, including three different scales of preprocedure patient anxiety, to determine which best predicted patient cooperation and satisfaction with gastrointestinal endoscopy. We prospectively evaluated 251 patients undergoing outpatient diagnostic esophagogastroduodenoscopy and colonoscopy under conscious sedation. All were given a questionnaire on arrival to our endoscopy center that included three measures of preprocedure anxiety: (a) a single question asking how anxious the patient was (termed "Anxiety I" scale); (b) a visual linear analog scale of anxiety; and (c) the Hospital Anxiety and Depression scale. Patient cooperation during the procedure was rated by the attending endoscopist. Patients were telephoned the next day to complete a questionnaire assessing their endoscopic experience. Logistic regression analysis was used to construct models for predicting which patients were most likely to have difficulty during their procedures from both the endoscopists' and the patients' standpoint. Statistical analysis identified three parameters that by themselves significantly correlated with patient cooperation during endoscopy: age (p = 0.008), Anxiety I scale (p = 0.03), and visual linear analog anxiety score (p = 0.02). When used together, age, type of procedure, and Anxiety I scale were the best predictors of patient cooperation from the standpoint of the endoscopist. Age, type of procedure, Anxiety I scale, and education level were the best predictors of satisfaction with endoscopy from the perspective of the patient. Good cooperation during endoscopy was associated with greater patient satisfaction.

Use of a pediatric colonoscope improves the success of total colonoscopy in selected adult patients.

BACKGROUND: Colonoscopy using a standard adult colonoscope can be difficult or impossible when there is a fixed, angulated sigmoid colon or stricture. It is sometimes possible to traverse such segments using a smaller-diameter, more flexible pediatric colonoscope. METHODS: For this prospective study, one endoscopist started 645 consecutive, elective colonoscopies with a standard adult Olympus CF-100L colonoscope (52% women, 48% men). There were 36 examinations (5.6%) in which the adult colonoscope could not be passed through a fixed, angulated sigmoid colon (n = 34) or a sigmoid colonic stricture (n = 2). In such instances (33 women and 3 men), the endoscopist switched to a pediatric colonoscope. RESULTS: The pediatric colonoscope successfully reached the cecum in 21 of the 36 cases (58.3%). The figure was 38.5% for the older Olympus CF-P20L fiberoptic colonoscope (n = 13) and 69.6% for the newer Olympus PCF-100 videocolonoscope (n = 23). Concomitant conditions in the 34 patients in whom the pediatric colonoscope was used because of a fixed, angulated sigmoid included previous pelvic surgery in 22, pelvic radiation therapy in 2, pelvic endometriosis in 3, and two with previous sigmoid diverticulitis. CONCLUSIONS: The pediatric colonoscope, and particularly the newer Olympus PCF-100 colonoscope, is very useful in adult patients in whom it is not possible to traverse a fixed, angulated sigmoid colon or stricture using the standard adult colonoscope. This is predominantly a problem of female patients. Previous pelvic surgery may be an important causative factor in this regard.

Are patients who undergo open-access endoscopy more anxious about their procedures than patients referred from the GI clinic?

OBJECTIVES: Our academic hospital center operates an open access endoscopy service that allows referring physicians to directly schedule patients for outpatient esophagogastroduodenoscopy and colonoscopy without having them first seen in the GI clinic. Although patients from the GI clinic have an opportunity to meet the endoscopist and discuss their procedures directly beforehand, patients who are scheduled to undergo endoscopy through our open access service receive only a brief telephone call from a GI fellow or nurse that is made to screen for contraindications to the procedure and to give instructions. Our objective was to find out whether patients who used our open access service were more anxious about their procedures than those referred from the GI clinic. METHODS: On arrival to our endoscopy center, consecutive patients from the open access service (n = 142) and the GI clinic (n = 85) completed a questionnaire that included three measures of anxiety. After completion of the endoscopic procedure, the attending endoscopist rated patient cooperation. Patients also completed a phone questionnaire on the day after their procedures assessing their experience with endoscopy. RESULTS: We found no difference between patients from the open access service and those from the GI clinic in any of the measures of preprocedure anxiety, in scores measuring cooperation during procedures, or in patient ratings of their experience with endoscopy as assessed on the day after procedures. CONCLUSIONS: Patients who used our open access service were no more anxious about their procedures or less cooperative during them than patients first seen in the GI clinic. In both groups, procedure-related anxiety was decreased in patients who had previously undergone endoscopy.