Aleksey A. Novikov

Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population

Background & Aims: The Orbera intragastric balloon (OIB) is a single fluid‐filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real‐world clinical settings. Methods: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinics database of patient demographics, outcomes of OIB placement (weight loss, weight‐related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. Results: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1–6 mo). Use of selective serotonin or serotonin‐norepinephrine re‐uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24–12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow‐up visits and weight loss at 3 months were associated with increased weight loss at 6 months (&bgr; = 0.5 and 1.2, respectively) (P < .05). Mean levels of cholesterol, triglycerides, low‐density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P < .05). Conclusions: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity‐related comorbidities in a real‐world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real‐world population, but were affected by use of medications.

One-step endoscopic ultrasound-directed gastro-gastrostomy ERCP for treatment of bile leak

A 32-year-old woman with a history of obesity who underwent Roux-en-Y gastric bypass in 2005 presented with acute cholecystitis. She underwent laparoscopic cholecystectomy, which was converted to open cholecystectomy owing to significant inflammation and adhesions. On postoperative Day 2, 300mL of bilious output was noted in the Jackson– Pratt drain, which raised concerns about a bile leak. The gastrointestinal department was consulted for endoscopic retrograde cholangiopancreatography (ERCP) and management of bile leak. Laparoscopy-assisted ERCP was felt to be high risk and difficult because of the patient’s recent open cholecystectomy with significant adhesions and inflammation. Enteroscopy-assisted ERCP was felt to have a low likelihood of success owing to a Roux limb length of > 150cm. A decision was made to pursue endoscopic ultrasound (EUS)-directed gastro-gastrostomy ERCP in one step (EDGE). EDGE involves the creation of a gastrogastrostomy fistula to gain access into the bypassed stomach. Conventional ERCP is then performed through the gastro-gastrostomy fistula after fistula maturation, which usually takes 4–6 weeks. Given the acute bile leak, EDGE was performed in one session with creation of the gastro-gastrostomy fistula tract under EUS guidance using a 15mm lumenapposing metal stent (▶Fig. 1), followed by conventional ERCP during the same session (▶Video1). ERCP showed an active bile leak (▶Fig. 2), and a fully covered metal stent was placed for biliary drainage. On postprocedure Day 1, the Jackson– Pratt drain output was no longer bilious and had decreased in volume. On postprocedure Day 2 the patient was discharged home. The patient returned for outpatient ERCP with stent removal 8 weeks later, and resolution of the bile leak was seen on the cholangiogram. After stent removal, the gastro-gastric fistula tract was closed with endoscopic suturing. EUS-guided gastro-gastrostomy ERCP has previously been described in a case series as a feasible multi-step alternative approach to balloon-assisted or laparoscopy-assisted ERCP in patients with altered anatomy from gastric bypass [1]. The technical success rate in creation of the gastro-gastrostomy fistula was 100%, and successful ERCP via the fistula tract was performed in 60% of cases. A mid-term follow-up study involving 16 patients showed improved clinical success approaching 90% [2]. The procedure was typically performed in multiple steps to allow for full maturation of the fistula. We describe here a case of the successful management of bile leak via the EDGE proceE-Videos

Hydralazine-Induced Vasculitis With Gastrointestinal Pseudomelanosis

A 71-year-old woman with end-stage renal disease on hemodialysis, hypertension, diabetes, coronary artery disease, and ischemic cardiomyopathy, on hydralazine 300 mg daily for 2 years, presented with a new onset of vesiculobullous rash, dysphagia, odynophagia, throat pain/tightness, and hoarseness. Physical exam showed multiple vesicles in her upper and lower extremities with significant airway edema and ulcerations of floor of mouth, tongue, epiglottis, aryepiglottic folds, and arytenoid edema. On admission day 3, she had an episode of gastrointestinal bleeding. Upper endoscopy and capsule endoscopy found petechiae and melanosis in the proximal small bowel, including most of duodenum and proximal jejunum (Figure 1). Pathology revealed necrotizing neutrophil-rich venulitis and pseudomelanosis.

Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastroplasty, and Laparoscopic Band for Weight Loss, How do they Compare?

Background Endoscopic sleeve gastroplasty (ESG) is a novel endobariatric procedure. Initial studies demonstrated an association of ESG with weight loss and improvement of obesity-related comorbidities. Our aim was to compare ESG to laparoscopic sleeve gastrectomy (LSG) and laparoscopic adjustable gastric banding (LAGB).

Endoscopic management of chronic pancreatitis with a fully covered self-expanding metal stent and laser lithotripsy

The patient was a 58-year-old man with a long-standing history of alcohol abuse and chronic pancreatitis leading to multiple hospitalizations. He continued to have pain despite conservative management, pain control, and alcohol cessation. His chronic pancreatitis and pancreatic duct (PD) stones resulted in a tight PD stricture at the head of the pancreas. Multiple prior attempts at conventional endoscopic retrograde cholangiopancreatography (ERCP) had failed. He presented to our institution seeking advanced therapy after extracorporeal shock wave lithotripsy (ESWL). At our index ERCP we could not get conventional transpapillary access to the PD. Instead, given his stone burden, after ESWL, we chose to treat him with an EUS-guided pancreaticogastrostomy, and placement of a fully covered self-expanding metal stent (FCSEMS) followed by a pancreatoscopy with holmium laser lithotripsy (▶Fig. 1 and ▶Fig. 2). The patient responded to treatment, with resolution of his pain at 12 months after the intervention. In chronic pancreatitis, chronic inflammation causes endocrine and exocrine insufficiency, pancreatic atrophy, calcification, and multiple pancreatic duct strictures that lead to chronic pain [1]. This chronic disease has much associated morbidity. Current therapies include pain control and supportive measures aimed at treatment of endocrine and exocrine insufficiencies. PD strictures and PD stones frequently accompany chronic pancreatitis. Endoscopic management of chronic pancreatitis includes ERCP with transpapillary plastic stent placement, PD balloon dilation, and ESWL for PD stones. FCSEMS placement has been reported as a treatment for refractory PD strictures in patients in whom other therapeutic modalities have failed [2]. However, in the patient described here, a conventional transpapillary ERCP approach for placement of the FCSEMS was not successful, and we used an EUS-guided technique to place an FCSEMS, and we then used this access for laser lithotripsy [3]. EUS-guided pancreaticogastrostomy is an option when conventional transpapillary stent placement is not possible. This case illustrates that pancreaticogastrostomy can be used as access for laser lithotripsy.

Endoscopic management of recurrent pyogenic cholangitis

Recurrent pyogenic cholangitis (RPC) can be challenging to manage. The case presented illustrates all the endoscopic techniques available to us to manage this difficult entity. A 54-year-old man with RPC presented with recurrent abdominal pain, fever, and jaundice. Magnetic resonance cholangiopancreatography (MRCP) showed an extensive stone burden. A conventional endoscopic retrograde cholangiopancreatography (ERCP) confirmed the magnetic resonance imaging (MRI) findings, but was unable to clear the extensive stone burden. Endoscopic ultrasound (EUS)-guided hepaticogastrostomy placement was performed to allow drainage of the left biliary system. After the tract had been allowed to mature, a repeat transgastric ERCP with cholangioscopic assistance was performed. Fluoroscopic and cholangioscopic visualization showed inflammation in the bile duct, but there were no stones visualized. A fully covered self-expandable metal stent (FCSEMS; 10mm×6cm) with an anchoring double-pigtail stent (7 Fr, 10 cm) were deployed, and the patient was discharged home. After 3 months, the patient returned for stent revision. The fistulous tract was cannulated with a sphincterotome and a hydrophilic guidewire. The wire was advanced across the ampulla into the duodenum with a swing-tip catheter. The duodenoscope was removed over the wire to perform a rendezvous procedure. The hepaticogastrostomy stent was revised, and the patient was again discharged home. He re-presented a few months later with cholecystitis and underwent a successful ERCP with placement of a transcystic biliary drain (10 Fr, 15 cm) (▶Fig. 1; ▶Video1). His condition then improved with antibiotics, and he was again discharged home. He went on to undergo liver transplantation (▶Fig. 2), and was recovering at home at the time of writing. RPC is a disease characterized by intrabiliary pigment stone formation that results in stricturing of the biliary tree and biliary obstruction with recurrent bouts of cholangitis [1]. Its etiology is thought to arise from bile stasis, transient portal bacteremia, and abnormal phospholipid metabolism. Stone clearance is the mainstay of therapy, and this can be accomplished invasively either through surgical resection, surgical T-tube placement, or non-invasively through ERCP [2]. Previous reports have indicated complete clearance of stones in 66% of cases [3]. E-Videos

Successful endoscopic removal of an eroded gastric ring with subsequent endoscopic suturing of the luminal defect

A 50-year-old woman with a history of Fobi Pouch Roux-en-Y gastric bypass (RYGB) presented to our hospital with abdominal pain, reflux, and significant weight loss. Initial endoscopic evaluation at an outside hospital revealed a Silastic ring that had eroded into the gastric pouch. The patient refused surgery and was referred to our institution for management. On upper endoscopy, there was evidence of a RYGB with an eroded Silastic ring protruding below the gastric pouch into the jejunum. A double-channel gastroscope was used. A rat tooth forceps (Rat Tooth Alligator Jaw Grasping Forceps; Olympus America Inc., Central Valley, Pennsylvania, USA) was deployed through one channel to grasp the ring from the mucosa. The ring was then dissected using endo-scissors (Olympus Endotherapy Loop Cutter; Olympus America Inc.,), which were inserted through the secondary channel. The endoscopic suturing system was used to repair the full-thickness defect created from ring removal. Three interrupted sutures were placed successfully across the gastrojejunal anastomosis, and a clinch was used to ensure closure of the ring defect. Closure was confirmed by lack of extravasation of contrast after injection (▶Fig. 1, ▶Video1). The procedure was well tolerated, and no adverse events occurred. At 1-month follow-up, the patient reported significant relief of her symptoms. The Silastic ring is a restrictive band, which is surgically placed around the gastrojejunal anastomosis in patients who have undergone RYGB. The intent is to further limit the size of the gastric pouch in order to achieve weight loss [1]. Possible causes of band erosion include: excessive constriction of the band, suturing the band to the stomach, and infection [2]. Symptomatic band migration or erosion necessitates removal [3]. E-Videos