Survival outcomes and predictors of mortality, re-bleeding and complications for acute severe variceal bleeding requiring balloon tamponade.

BACKGROUND: Acute severe variceal bleeding (AVB) refractory to medical and endoscopic therapy is infrequent but associated with high mortality. Historical cohort studies from 1970-1980s no longer represent the current population as balloon tamponade is no longer first-line therapy for variceal bleeding; treatments including vasoactive therapies, intravenous antibiotics, endoscopic variceal band ligation are routinely used, and there is improved access to definitive treatments including transjugular intrahepatic portosystemic shunts. However, only a few studies from the current era exist to describe the practice of balloon tamponade, its outcomes, and predictors with a requirement for further updated information. AIM: To describe current management of AVB requiring balloon tamponade and identify the outcomes and predictors of mortality, re-bleeding and complications. METHODS: A retrospective multi-centre cohort study of 80 adult patients across two large tertiary health networks from 2008 to 2019 in Australia who underwent balloon tamponade using a Sengstaken-Blakemore tube (SBT) were included for analysis. Patients were identified using coding for balloon tamponade. The primary outcome of this study was all-cause mortality at 6 wk after the index AVB. Secondary outcomes included re-bleeding during hospitalisation and complications of balloon tamponade. Predictors of these outcomes were determined using univariate and multivariate binomial regression. RESULTS: The all-cause mortality rates during admission and at 6-, 26- and 52 wk were 48.8%, 51.2% and 53.8%, respectively. Primary haemostasis was achieved in 91.3% and re-bleeding during hospitalisation occurred in 34.2%. Independent predictors of 6 wk mortality on multivariate analysis included the Model for Endstage Liver disease (MELD) score (OR 1.21, 95%CI 1.06-1.41, P = 0.006), advanced hepatocellular carcinoma (OR 11.51, 95%CI 1.61-82.20, P = 0.015) and re-bleeding (OR 13.06, 95%CI 3.06-55.71, P < 0.001). There were no relevant predictors of re-bleeding but a large proportion in which this occurred did not survive 6 wk (76.0% vs 24%). Although mucosal trauma was the most common documented complication after SBT insertion (89.5%), serious complications from SBT insertion were uncommon (6.3%) and included 1 patient who died from oesophageal perforation. CONCLUSION: In refractory AVB, balloon tamponade salvage therapy is associated with high rates of primary haemostasis with low rates of serious complications. Re-bleeding and mortality however, remain high.

Does ERCP position matter? A randomized controlled trial comparing efficacy and complications of left lateral versus prone position (POSITION study).

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is traditionally performed with patients in the prone position (PP). However, this poses a potentially increased risk of anesthetic complications. An alternative is the left lateral (LL) decubitus position, which is commonly used for endoscopic procedures. Our aim was to compare cannulation rate, time, and outcomes in ERCP performed in LL versus PP. Patients and methods We conducted a non-inferiority, prospective, randomized control trial with 1:1 randomization to either LL or PP position. Patients > 18 years of age with native papillae requiring a therapeutic ERCP were recruited between March 2017 and November 2018 in a single tertiary center. Results A total of 253 patients were randomized; 132 to LL (52.2 %) and 121 to PP (47.8 %). Cannulation rates were 97.0 % in LL vs 99.2 % in PP (difference -2.2 % (one-sided 95 % CI: -5 % to 0.6 %). Median time to biliary cannulation was 03:50 minutes in LL vs 02:57 minutes in PP ( P  = 0.62). Pancreatitis rates were 2.3 % in LL vs 5.8 % in PP ( P  = 0.20). There were significantly lower radiation doses used in PP (0.23 mGy/m 2 in LL vs 0.16 mGy/m 2 in PP, P  = 0.008) without a difference in fluoroscopy times. Conclusions Our analysis comparing LL to PP during ERCP shows comparable procedural and anesthetic outcomes, with significantly lower radiation exposure when performed in PP. We conclude that ERCP undertaken in the LL position is not inferior to PP, except for higher radiation exposure, and should be considered as a safe alternate position for patients undergoing ERCP.

Immunomodulator use does not prevent first loss of response to anti-tumour necrosis factor alpha therapy in inflammatory bowel disease: long-term outcomes in a real-world cohort.

BACKGROUND: Recent prospective studies suggest combination therapy with immunomodulators improves efficacy, but long-term data is limited. AIM: To assess whether anti-tumour necrosis factor alpha (anti-TNF) monotherapy was associated with earlier loss of response (LOR) than combination therapy in a real-world cohort with long-term follow up. METHODS: A retrospective audit was conducted of inflammatory bowel disease patients receiving anti-TNF therapy in a tertiary centre and specialist private practices. All patients with accurate data for anti-TNF commencement and adequate correspondence to determine end-points were included. Outcomes measured included time to first LOR, causes and biochemical parameters. RESULTS: Two hundred and twenty-four patients were identified; 139 (62.1%) on combination therapy and 85 (37.9%) on monotherapy. Forty-five percent of patients had LOR during follow up until a maximum of 8.5 years; 59.4% on combination therapy and 40.6% on monotherapy (P = 0.533). The median time to LOR was not different between groups; 1069 days for combination therapy and 1489 days for monotherapy (P = 0.533). There was no difference in time to LOR between patients treated with different combination regimens or different anti-TNF agents. CONCLUSION: In this large cohort of patients in a real-world setting, patients treated with anti-TNF monotherapy had similar rates of LOR as patients on anti-TNF combination therapy, at both short- and long-term follow up.

Carbon Dioxide Insufflation Increases Colonoscopic Adenoma Detection Rate Compared With Air Insufflation.

GOALS: To determine the effect of carbon dioxide insufflation on the most important outcome measure of colonoscopic quality: adenoma detection rate (ADR). BACKGROUND: Bowel cancer is the second most common cause of cancer deaths in males and females in Australia. Carbon dioxide has in recent times become the insufflation methodology of choice for screening colonoscopy for bowel cancer, as this has been shown to have significant advantages when compared with traditional air insufflation. STUDY: Endoscopies performed over a period of 9 months immediately before and after the implementation of carbon dioxide insufflation at endoscopy centers were eligible for inclusion. RESULTS: The difference in ADR between the carbon dioxide and air insufflation methods was statistically significant, with an increased ADR in the carbon dioxide group. The superiority of carbon dioxide insufflation was sustained with a logistic regression model, which showed ADR was significantly impacted by insufflation method. CONCLUSIONS: Carbon dioxide insufflation is known to reduce abdominal pain, postprocedural duration of abdominal pain, abdominal distension, and analgesic requirements. This study represents for the first time the beneficial effect of carbon dioxide insufflation upon the key quality colonoscopy indicator of ADR.

Gastroduodenal outlet obstruction and palliative self-expandable metal stenting: a dual-centre experience.

Background. Self-expandable metal stents (SEMs) are increasingly being utilised instead of invasive surgery for the palliation of patients with malignant gastroduodenal outlet obstruction. Aim. To review two tertiary centres' experience with placement of SEMs and clinical outcomes. Methods. Retrospective analysis of prospectively collected data over 12 years. Results. Ninety-four patients (mean age, 68; range 28-93 years) underwent enteral stenting during this period. The primary tumour was gastric adenocarcinoma in 27 (29%) patients, pancreatic adenocarcinoma in 45 (48%), primary duodenal adenocarcinoma in 8 (9%), and cholangiocarcinoma and other metastatic cancers in 14 (16%). A stent was successfully deployed in 95% of cases. There was an improvement in gastric outlet obstruction score (GOOS) in 84 (90%) of patients with the ability to tolerate an enteral diet. Median survival was 4.25 months (range 0-49) without any significant differences between types of primary malignancy. Mean hospital stay was 3 days (range 1-20). Reintervention rate for stent related complications was 5%. Conclusion. The successful deployment of enteral stents achieves excellent palliation often resulting in the prompt reintroduction of enteral diet and early hospital discharge with minimal complications and reintervention.

Needle knife sphincterotomy does not increase the risk of pancreatitis in patients with difficult biliary cannulation.

BACKGROUND & AIMS: Biliary cannulation is unsuccessful during 5%-10% of endoscopic retrograde cholangiopancreatography (ERCP) procedures. Needle knife sphincterotomy (NKS) can improve success of cannulation but is often used as a last resort and is associated with post-ERCP pancreatitis (PEP). We evaluated the safety and efficacy of performing NKS during early stages of difficult cannulation and the relationship between difficult cannulation and the risk of PEP. METHODS: We performed a prospective trial of consecutive patients with an intact papilla who were undergoing ERCP at tertiary referral center; 73 patients were defined as having difficult biliary cannulation according to predefined cannulation parameters. These patients were randomly assigned to groups that received either NKS or continued standard cannulation. Main outcome measures were PEP and successful biliary cannulation. RESULTS: Of 464 patients with an intact papilla undergoing ERCP, 73 met the criteria for difficult cannulation. Cannulation success in difficult cannulation cases was 86%, with a PEP rate of 19%. There was no difference in eventual cannulation success between the groups. However, 65% of the patients assigned to the standard cannulation group required crossover to NKS. There was no significant difference in development of PEP among patients in the early NKS group (20.5%) vs standard cannulation (17.6%). Pancreatic duct stents were inserted in 23 of the patients in the early NKS arm and in 15 in the standard cannulation arm. The number of cannulation attempts (more than 7) increased the risk of PEP (P < .01). On the basis of multivariate analysis, independent risk factors for PEP were failure of early cannulation and failure of biliary cannulation. CONCLUSIONS: Early application of NKS during difficult cannulation does not increase the risk of PEP. The risk of PEP increases greatly after 7-8 attempts at or failure of cannulation. Further studies are required to assess whether early implementation of NKS during difficult cannulation reduces the development of PEP. Australia and New Zealand Clinical Trials registry: ANZTRN 12,612,000,060,842.

Failed biliary cannulation: clinical and technical outcomes after tertiary referral endoscopic retrograde cholangiopancreatography.

AIM: Prospective evaluation of repeat endoscopic retrograde cholangiopancreatography (ERCP) for failed Schutz grade 1 biliary cannulation in a high-volume center. METHODS: Prospective intention-to-treat analysis of patients referred for biliary cannulation following recent unsuccessful ERCP. RESULTS: Fifty-one patients (35 female; mean age: 62.5 years; age range: 40-87 years) with previous failed biliary cannulation were referred for repeat ERCP. The indication for ERCP was primarily choledocholithiasis (45%) or pancreatic malignancy (18%). Successful biliary cannulation was 100%. The precut needle knife sphincterotomy (NKS) rate was 27.4%. Complications occurred in 3.9% (post-ERCP pancreatitis). An identifiable reason for initial unsuccessful biliary cannulation was present in 55% of cases. Compared to a cohort of 940 naïve papilla patients (female 61%; mean age: 59.9 years; age range: 18-94 years) who required sphincterotomy over the same time period, there was no statistical difference in the cannulation success rate (100% vs 98%) or post-ERCP pancreatitis (3.1% vs 3.9%). Precut NKS use was more frequent (27.4% vs 12.7%) (P = 0.017). CONCLUSION: Referral to a high-volume center following unsuccessful ERCP is associated with high technical success, with a favorable complication rate, compared to routine ERCP procedures.

The target sign: an endoscopic marker for the resection of the muscularis propria and potential perforation during colonic endoscopic mucosal resection.

BACKGROUND: EMR of large sessile polyps and laterally spreading tumors (LSTs) of the colon is safe and cost-effective. Perforation remains a feared and well-recognized complication; however, endoscopic detection is often absent, and most commonly, diagnosis is delayed and depends on clinical signs and/or radiology findings. To date, an endoscopic sign to identify muscularis propria (MP) resection and potential perforation has not been described. OBJECTIVE: To describe an endoscopic sign for prompt recognition of EMR-related MP resection. DESIGN: Prospective analysis. SETTINGS: Tertiary referral academic gastroenterology unit. PATIENTS: Patients with the target sign were identified prospectively in 2 large prospective studies of EMR for colonic LSTs 20 mm or larger. INTERVENTION: A standardized EMR approach was used. MP defects were closed endoscopically with clips. MAIN OUTCOME MEASUREMENTS: The presence or absence of the target sign in the polypectomy specimen and its influence on subsequent endoscopic management of polypectomy complications. RESULTS: A total of 445 patients with LSTs or sessile polyps 20 mm or larger (mean size 33 mm, range 20-85 mm) were prospectively enrolled in 2 studies. Ten patients (mean age 70.3 years, range 48-83 years, 50% male) with target lesions and histologically confirmed MP resection were identified prospectively at the time of EMR, with 3 having full-thickness resection. All cases were identified intraprocedurally by a target sign on the underside of the specimen and a mirror target evident in the mucosal defect. All patients were treated endoscopically with 1 to 5 endoscopic clips. None required operative management. Thirteen inpatient days were required to treat the 10 patients (mean 1.3 days). LIMITATIONS: Nonrandomized study. CONCLUSIONS: Careful analysis of the post-EMR specimen and resection defect may reveal a target sign, an easily recognized and reliable marker of either partial- or full-thickness MP resection and potential perforation. Prompt recognition of this sign facilitates endoscopic management.

Efficacy and safety of single-session argon plasma coagulation in the management of chronic radiation proctitis.

BACKGROUND: Chronic radiation proctitis (CRP) manifests as rectal bleeding 12 to 24 months after pelvic radiotherapy. No criterion standard of treatment has been established, although argon plasma coagulation (APC) has increasingly become the treatment of choice. Previous studies have applied APC over multiple sessions, necessitating increased numbers of treatments. OBJECTIVE: To assess the safety and efficacy of large-volume APC application in the treatment of CRP with the intention of a single-session treatment protocol. DESIGN: Prospective study. SETTING: Tertiary referral hospital. PATIENTS: Over an 8-year period, consecutive patients with CRP with rectal bleeding were prospectively enrolled. INTERVENTION: Large-volume APC application to affected rectal mucosa. MAIN OUTCOME MEASUREMENTS: Number of treatments, bleeding scores, complications. RESULTS: Fifty patients (mean age 72.1 years; range 51-87 years) were treated; 45 were men (prostate cancer). The mean period between radiotherapy and initial APC treatment was 23 months (range 4-140 months). Seventeen (34%) patients had grade A endoscopic severity, 23 (46%) grade B, and 10 (20%) grade C. Other therapies failed in 16 (32%) patients. The mean number of treatments was 1.36 (range 1-3) with a mean follow-up of 20.6 months (range 6-48 months). Sixty-eight percent of patients were successfully treated after 1 session and 96% after 2 sessions. Bleeding scores improved in all patients (P < .001). Seventeen (34%) patients experienced short-term, self-limiting complications; 1 (2%) patient experienced a long-term complication. LIMITATIONS: Nonrandomized study. CONCLUSIONS: Large-volume APC treatment was successful in the treatment of CRP, including those in whom other therapies had previously failed, and resulted in a decreased number of treatments compared with other published studies. The benefits were offset by an increased incidence of short-term complications but no increase in long-term complications.

Giant laterally spreading tumors of the papilla: endoscopic features, resection technique, and outcome (with videos).

BACKGROUND: Successful endoscopic treatment of conventional papillary adenomas is well described. However, many authors recommend surgical resection for larger lesions with extrapapillary extension. OBJECTIVE: To describe the classification, technique, and outcome for the endoscopic resection of giant laterally spreading tumors of the papilla (LST-P). DESIGN: Single-center case series. SETTINGS: Tertiary referral academic gastroenterology unit. PATIENTS: Patients referred for endoscopic treatment of LST-P. INTERVENTION: Pre-resection staging and single-session endoscopic removal of papillary adenomas. For those classified as LST-P (>30 mm, extending beyond the papilla onto the duodenal wall and involving as much as two thirds of the duodenal circumference), a standardized single-session EMR technique was used. MAIN OUTCOME MEASUREMENTS: Technical success, complications, and adenoma recurrence for single-session removal of LST-P. Outcomes were compared with those of conventional ampullary adenoma resection during the same period. RESULTS: Twenty-five patients with ampullary adenomas were referred. In 10 patients identified with LST-P (mean age 70.2 years; adenoma size 30-80 mm), combination EMR and papillectomy was performed in a single session. The median admission duration was 1 night (range 0-35). Complications included bleeding (30%) and cholecystitis (10%), with no cases of pancreatitis or perforation. Adenoma recurrence at 3 months was found in 1 patient (10%). Complication and recurrence rates in smaller (<30 mm) ampullary adenoma resections were not significantly different. LIMITATIONS: A relatively uncommon entity and thus small sample size. CONCLUSIONS: Endoscopic resection of carefully staged LST-P is a viable therapeutic alternative to surgery. In experienced hands, the outcomes are comparable to those for conventional ampullary adenomas.

Endoscopic resection for Barrett's high-grade dysplasia and early esophageal adenocarcinoma: an essential staging procedure with long-term therapeutic benefit.

OBJECTIVES: Patients with Barrett's high-grade dysplasia (HGD) or early esophageal adenocarcinoma (EAC) that is shown on biopsy alone continue to undergo esophagectomy without more definitive histological staging. Endoscopic resection (ER) may provide more accurate histological grading and local tumor (T) staging, definitive therapy, and complete Barrett's excision (CBE); however, long-term outcome data are limited. Our objective was to demonstrate the effect on histological grade or local T stage, efficacy, safety and long-term outcome of ER for Barrett's HGD/EAC and of CBE in suitable patients. METHODS: This prospective study at two Australian academic hospitals involved 75 consecutive patients over 7 years undergoing ER for biopsy-proven HGD or EAC, using multiband mucosectomy or cap technique. In addition, CBE by 2-3-stage radical mucosectomy was attempted for all Barrett's segments

Large refractory colonic polyps: is it time to change our practice? A prospective study of the clinical and economic impact of a tertiary referral colonic mucosal resection and polypectomy service (with videos).

BACKGROUND: Patients who have large, difficult, colorectal lesions not readily amenable to endoscopic resection are often referred directly to surgery. The application of advanced polypectomy and endoscopic mucosal resection (EMR) techniques undertaken by a tertiary referral colonic mucosal resection and polypectomy service (TRCPS) is not often considered but may be superior to surgery. OBJECTIVE: To evaluate the safety, efficacy, and cost savings of a TRCPS for colorectal lesions. DESIGN: Prospective intention-to-treat analysis. SETTING: Tertiary academic referral center. PATIENTS: In a 21-month period ending in April 2008, consecutive patients with large or complex colorectal polyps referred by other specialist endoscopists were prospectively enrolled on an intention-to-treat basis. INTERVENTION: For sessile lesions, a standardized EMR approach was used. Pedunculated lesions were removed with or without pretreatment with an Endoloop procedure. MAIN OUTCOME MEASUREMENTS: Complete resection, complications, recurrence, and potential cost savings comparing actual outcome of the cohort with a hypothetical analysis of surgical management. RESULTS: This study included 174 patients (mean age 68 years) who were referred with 193 difficult polyps (186 laterally spreading, mean size 30 mm [range 10-80 mm]). We totally excised 173 laterally spreading lesions by EMR (115 piecemeal, 58 en bloc). Invasive adenocarcinoma was found in 6 lesions-5 treated successfully with EMR. Eleven patients were referred directly to surgery without an endoscopic attempt due to suspected invasive carcinoma. Seven >30-mm, pedunculated polyps were removed. There were no perforations. A total of 20 bed days was used because of endoscopic complications. Among all patients referred, 90% avoided the need for surgery. Excluding patients who were treated surgically for invasive cancer, the procedural success was 95% (157 of 168). By using Australian cost estimates applied to the entire group and compared with cost estimates assuming all patients had undergone surgery, we calculated the total medical cost savings was $6990 (U.S.) per patient, or a total savings of $1,216,231 (U.S.). LIMITATION: Not a randomized trial. CONCLUSIONS: Colonoscopic polypectomy performed by a TRCPS on large or difficult polyps is technically effective and safe. This approach results in major cost savings and avoids the potential complications of colonic surgery. This type of clinical pathway should be developed to enhance patient outcomes and reduce health care costs.

En-bloc resection of multiple type 1 gastric carcinoid tumors by endoscopic multi-band mucosectomy.

BACKGROUND AND AIM: Gastric carcinoid tumors are rare but increasing in incidence. Current recommendations suggest endoscopic resection for type I carcinoids found in the stomach, however reports of incomplete resection have led to difficulty planning future management. Our purpose was to describe the application of the endoscopic multi-band mucosectomy (MBM) device to achieve en-bloc resection of multiple gastric carcinoid tumors. METHODS: Over a 30-month period (June 2006-January 2009) eight patients attending for endoscopic assessment of gastric carcinoid tumors were identified at two tertiary referral centers. Patients underwent endoscopic resection of the carcinoids with an MBM device. En-bloc specimens underwent histological evaluation for identification and tumor resection margins. Patients with type I carcinoids were subsequently enrolled in an endoscopic follow-up program. RESULTS: A total of 34 gastric carcinoid tumors were removed from eight patients. On histological analyses seven out of eight patients were diagnosed with type I tumors. In the remaining patient a single, sporadic (type III) gastric carcinoid was diagnosed. No complications of severe bleeding or perforation occurred. All specimens were shown to have clear deep and peripheral histological resection margins. CONCLUSION: Complete 'en-bloc' endoscopic resection of multiple 'type I' gastric carcinoid tumors can be safely and easily performed with an MBM technique.