The PillSense System, a novel blood-sensing swallowed capsule device, safely detected blood in patients with clinically suspected upper gastrointestinal bleeding with a sensitivity of 92.9% and a specificity of 90.6%, data showed.
“[Esophagogastroduodenoscopy] is now considered the gold standard for diagnosing and treating [upper GI bleeding (UGIB)], although timely diagnosis and intervention can be challenging from a time, personnel and access perspective,” Karl Akiki, MD, a research fellow in the division of gastroenterology and hepatology at Mayo Clinic College of Medicine and Science, and colleagues wrote in Gastrointestinal Endoscopy. “Hence, an accurate, rapid, easy-to-interpret and noninvasive tool could assist in both diagnosing and offering guidance for clinical decision-making in scenarios of a suspected UGIB.”
In an open-label, single-arm, comparative clinical trial, Akiki and colleagues evaluated the safety and efficacy of the PillSense System (EnteraSense Ltd.), an ingestible capsule that detects blood in the upper GI tract via an optical sensor and transmits data to an external receiver.
They enrolled 126 adults (mean age, 62.4 years; 59.5% men) with suspected UGIB at Mayo Clinic in Rochester between December 2021 and August 2022. Participants underwent esophagogastroduodenoscopy (EGD) within 4 hours of capsule administration and were monitored up to 21 days to confirm capsule passage.
According to results, 110 patients (87.3%) had confirmed capsule passage, with a mean transit time of 3.6 days. The capsule correctly detected the presence of blood in 26 out of 28 cases and the absence of blood in 87 out of 96 cases compared with EGD. The mean PillSense recording time was 6.71 minutes.
Further analysis demonstrated a sensitivity and specificity of 92.9% (95% CI, 76.5-99.1) and 90.6% (95% CI, 82.9-95.6), respectively, as well as positive and negative predictive values of 74.3% and 97.8%. The positive and negative likelihood ratios were 9.9 and 0.08.
Researchers reported no adverse events related to the PillSense System or capsule ingestion.
“Our study demonstrates that a novel blood-sensing swallowed capsule device provides highly accurate and rapid detection of UGIB,” Akiki and colleagues concluded. “The device was simple to deploy, results were easy to interpret and the capsule passed safely through the GI tract in all patients that completed the study.”
They continued: “The PillSense System may assist in efficiently diagnosing UGIB with the goal of improving patient outcomes and may ultimately alter the diagnostic and treatment approach for patients with a suspected UGIB.”
Summary: Cannabis users undergoing gastric endoscopy procedures generally require more sedation than non-cannabis users, researchers report.
Source: American Gastroenterology Association
Patients who use cannabis required higher levels of sedation during gastric endoscopies than non-users, according to research to be presented at Digestive Disease Week (DDW) 2022.
As cannabis is legalized in more places and usage rises, clinicians should be aware of patients’ habits and prepare themselves and their patients for increased sedation and accompanying risks, researchers said.
“Patients didn’t have increased awareness or discomfort during procedures, but they did require more drugs,” said Yasmin Nasser, MD, Ph.D., lead researcher on the study and assistant professor at Snyder Institute for Chronic Diseases Cumming School of Medicine University of Calgary.
Researchers conducted a prospective cohort study of 419 adult outpatients undergoing endoscopic procedures at three Canadian centers. Procedures were conducted under conscious sedation, which leaves the patient relaxed and comfortable but partially conscious during the procedure.
Each patient completed two questionnaires, one before the procedure about their cannabis use and another afterwards indicating their awareness and comfort level during the procedure.
The questionnaires were analyzed along with details about the use of the sedatives midazolam, fentanyl and diphenhydramine during the procedure.
Cannabis use was associated with increased odds of requiring higher total sedation—defined as more than 5 mg of midazolam, or more than 100 mcg of fentanyl, or the need for diphenhydramine—during gastroscopy, an endoscopic procedure that begins with insertion of a tube and camera through the throat.
Cannabis use was not associated with higher use of sedation during colonoscopy. Gastroscopy generally requires more sedation than colonoscopy because the inserted scope causes irritation in the upper part of the gastrointestinal tract, often triggering the gag reflex.
This study looked at whether patients were users or non-users of cannabis, but did not examine the timing, quantity or route of cannabis intake prior to procedure, whether it was inhaled, vaporized, ingested or otherwise. Researchers say these variables could be the basis for future study.
Also, researchers only examined the impacts of baseline cannabis use during procedures that use conscious sedation and did not examine its impact on propofol sedation, which is more commonly used in the U.S.
New York—What do colonoscopy, polypectomy and endobiliary stenting all have in common? They are all endoscopic techniques first described by surgeons, along with control of hemorrhage, endoscopic retrograde cholangiopancreatography, percutaneous endoscopic gastrostomy/jejunostomy and control of variceal bleeding.
“It’s an old adage that general surgeons started endoscopy and gave it up to the gastroenterologists,” said Paresh C. Shah, MD, professor of surgery at NYU Langone School of Medicine, in New York City. “Unfortunately, that’s true, but we’re changing that and we need to be aggressive about it.”
The American Board of Surgery has acknowledged the importance of surgical endoscopy through changes in residency training requirements for board eligibility. Starting in 2018, surgical residents will have to complete a flexible endoscopy curriculum and pass the Fundamentals of Endoscopic Surgery (FES) examination assessing their cognitive and technical skills. The FES program was developed by the Society of American Gastrointestinal and Endoscopic Surgeons.
But surgical endoscopy can expand and enhance practice for surgeons at any stage in their career, Dr. Shah explained at the 2016 Controversies, Problems & Techniques in Surgery annual meeting, noting that it was general surgeons again who played a role in promoting some of the more advanced endoscopic interventions, such as EndoCinch suturing, Stretta, anastomotic plication and peroral endoscopic myotomy (POEM).
“If we think of ourselves as gastrointestinal surgeons, we’re really obligated to look at the spectrum of what GI surgery is. Advanced endoscopy, therapeutic endoscopy, is nothing more than another form of GI surgery; it’s just one that happens within the lumen rather than outside.”
In the world of diagnostic endoscopy, some of the newer tools that surgeons have include microendoscopy and narrow-band imaging. “For those of you who do diagnostic upper and lower endoscopy, these are critical to have at your disposal,” Dr. Shah said. “They’ve impacted adenoma detection rate, early cancer detection, and clearly, postsurgical anatomy.”
As Jose Martinez, MD, pointed out, nobody understands postsurgical anatomy better than the surgeon who made it. “We do a lot of replumbing in the human body, and we know the plumbing doesn’t always work. We can end up with strictures or worse—a leak, fistula or perforations,” said Dr. Martinez, associate professor of surgery and chief of laparoendoscopic surgery at the University of Miami Miller School of Medicine.
Basic tools for interventional endoscopy include balloon dilation, bleeding control and feeding tubes. More advanced interventions—to manage complications that surgeons themselves may have created—include stents, clips, fibrin glue and endoscopic suturing.
Injection is an important skill to develop. “It allows you to do a lot of things in the GI tract, whether you’re injecting saline to lift the mucosa, tattoo to mark a lesion or epinephrine to control bleeding,” Dr. Shah said.
When it comes to dealing with strictures, surgeons again have a number of tools at their disposal: stents, energy sources, balloons and dilators. “Many of these things were created for one purpose, but we’re using them in different ways to figure out how to best accomplish treatment for our patient,” Dr. Martinez said.
And then there are the very advanced endoscopic interventions: POEM, gastric POEM (G-POEM), ESD and endoscopic full-thickness resection (EFTR). “G-POEM changed our practice—I don’t do pyloroplasties anymore; and ESD and EFTR are now the avant- garde of what we can do endoluminally,” Dr. Shah said.
Incorporating Endoluminal Techniques
Jeffrey Marks, MD, long a promoter of flexible endoscopy, acknowledged that while the younger generation of surgeons might be more comfortable with it—especially the residents who will have to pass the FES and complete the flexible endoscopy curriculum in 2018 before sitting for their boards—more established surgeons can be a tougher sell.
“The hardest person to impress is the person outside fellowship and residency, someone in practice already. If they’re not doing flexible endoscopy, it’s hard to get them started,” said Dr. Marks, professor of surgery and director of surgical endoscopy at Case Western/University Hospitals, Cleveland Medical Center, in Ohio.
Drs. Marks and Shah recommend surgeons start with intraoperative assessment. “For one thing, the GI doctors aren’t going to want to come in to assess every anastomosis or bariatric bypass; also, the patient being asleep makes it easier—you don’t have to worry about them being uncomfortable—so it’s a great way to gain skills.”
Dr. Shah suggests having an endoscope involved in every case. “There is no downside to you doing your own intraoperative endoscopy, whether it’s foregut or colon.”
Once a surgeon has gained some comfort, some formal training can advance his or her competence. “Both the American College of Surgeons and the Society of American Gastrointestinal and Endoscopic Surgeons have hands-on courses for surgeons who have a basic skill set in flexible endoscopy to learn how to do more advanced therapies,” Dr. Marks said.
Dr. Shah also recommends working with GI colleagues to build one’s skill set for more advanced endoscopic procedures. “Most of them have more experience than you with the more advanced procedures,” he said.
This can be difficult politically in situations where gastroenterologists sense a turf war and resist sharing what they know, but the reality, according to Dr. Shah, is that most gastroenterologists are more than willing to turn over the more challenging and relatively less remunerative advanced endoscopic procedures. “It does not pay for them to do a two-hour procedure when they can do six screening colonoscopies in the same time. The reimbursement isn’t there for them, the interest isn’t there for them, and they don’t want to be responsible for potential complications.
“If you have a therapeutic or developmental endoscopist in your area or practice, partner with them,” he said. They’ll love to have that work with you. And if you don’t have a therapeutic endoscopist, there’s a very good opportunity for you to become that person for your GI community. They’ll be happy to do your pre-ops, screenings and post-ops, and to call on you when they need one of these more advanced therapeutic endoscopic procedures.”
The number of cases of metastatic colorectal cancer treated by chemotherapy without primary tumor resection has recently increased. However, evaluation of primary tumor response by computed tomography is difficult in such cases. In this study, the usefulness of evaluation of primary tumor response to chemotherapy by endoscopy was investigated.
This retrospective analysis was performed at the Shizuoka Cancer Center and included 31 patients (88 evaluations) with metastatic colorectal cancer. Computed tomography and endoscopy were performed concomitantly between September 2002 and June 2006. Patients were treated by systemic chemotherapy without prophylactic primary tumor resection. Definitions of primary tumor response were as follows: (1) complete response, confirmed by colorectal biopsy; (2) progressive disease, enlargement of at least one of five tumor parameters; and (3) neither (1) nor (2). Computed tomography was performed to evaluate primary tumor response according to the Response Evaluation Criteria in Solid Tumors and to identify colorectal stenosis secondary to primary tumors.
The rate of concordance between endoscopy and computed tomography for evaluation of primary tumor response was 75 %. Colorectal stenosis was detected 14 times by endoscopy (9 cases) and 3 times by computed tomography (3 cases). Of the 7 patients in whom surgery was required, 6 exhibited stenotic symptoms before endoscopic detection.
With regard to primary tumor response evaluation, a high concordance rate was observed between endoscopy and computed tomography, although endoscopic evaluation appeared more sensitive in detecting colorectal stenosis requiring surgical treatment.
| The Glasgow-Blatchford score was superior to the Rockall score in predicting the need for transfusions or surgery in patients admitted for UGIB, but use of any risk stratification system is still of primary importance. |
| The Glasgow-Blatchford score (GBS) is commonly used to distinguish patients with upper gastrointestinal bleeding (UGIB) who are at low versus high risk for rebleeding or death from endoscopy. The Rockall score (RS) has been widely used both before and after endoscopy to stratify patients according to their risk for mortality. Now, researchers in Australia have compared the performances of these tools in predicting the need for interventions and clinical outcomes in 708 patients hospitalized for UGIB who underwent urgent endoscopy.
Compared with post-endoscopy RS and GBS, pre-endoscopy RS was less effective in predicting the need for endoscopic therapy (area under the curve, 0.76 and 0.76 vs. 0.66, respectively). Compared with the full RS and GBS, pre-endoscopy RS was less effective in predicting rebleeding (AUC, 0.64 and 0.71 vs. 0.57, respectively). Compared with both pre-endoscopy RS and post-endoscopy RS, the GBS more accurately predicted the need for both blood transfusion (AUC, 0.70 and 0.68 vs. 0.81, respectively) and surgery (AUC, 0.64 and 0.51 vs. 0.71, respectively). COMMENTThe authors conclude that the Glasgow-Blatchford score is as accurate as the full Rockall score in predicting rebleeding and the need for endoscopic therapy and superior to the RS in predicting the need for transfusions or surgery in patients hospitalized for upper gastrointestinal bleeding. The results of this study may be affected by the inclusion of patients with variceal bleeding, the unblinded decisions of physicians on the need for endoscopy and transfusions, and the absence of posthospitalization follow-up. Also, the authors used a higher GBS cutoff value for interventions than that used in previous studies (3 vs. 1). Nonetheless, these results support those of multiple studies in which the efficacy of both the GBS and RS in risk stratification of patients with upper gastrointestinal bleeding, as well as that of a simplified system called AIMS65, have been demonstrated (NEJM JW Gastroenterol Feb 22 2013 and NEJM JW Gastroenterol Dec 9 2011). Overall, I believe that the importance of using any risk stratification tool in this setting is still of primary concern compared with the question of which scoring system to use. |
Source: NEJM
Localizing obscure gastrointestinal bleeding can be a clinical challenge, despite the availability of various endoscopic, imaging, and visceral angiographic techniques. We reviewed the management of patients presenting with obscure gastrointestinal bleeding during the period from 2005 to 2011. Four patients had preoperative localization of the bleeding site with superselective mesenteric angiography, which was confirmed by the use of intraoperative methylene blue injection. This novel technique allowed us to identify the abnormal pathology, and, consequently, resection of the implicated segment of small bowel was performed without any postoperative complications. Final histology showed that 2 patients had arteriovenous malformations: one had a benign hemangioma of the small bowel, and the other had chronic ischemic ulceration in the ileum. Superselective mesenteric angiography combined with intraoperative localization with methylene blue is an important and innovative technique in the management of patients with unclear sources of gastrointestinal bleeding and allows for effective hemorrhage control with a focused and therefore limited bowel resection.
Source: JAMA
Localizing obscure gastrointestinal bleeding can be a clinical challenge, despite the availability of various endoscopic, imaging, and visceral angiographic techniques. We reviewed the management of patients presenting with obscure gastrointestinal bleeding during the period from 2005 to 2011. Four patients had preoperative localization of the bleeding site with superselective mesenteric angiography, which was confirmed by the use of intraoperative methylene blue injection. This novel technique allowed us to identify the abnormal pathology, and, consequently, resection of the implicated segment of small bowel was performed without any postoperative complications. Final histology showed that 2 patients had arteriovenous malformations: one had a benign hemangioma of the small bowel, and the other had chronic ischemic ulceration in the ileum. Superselective mesenteric angiography combined with intraoperative localization with methylene blue is an important and innovative technique in the management of patients with unclear sources of gastrointestinal bleeding and allows for effective hemorrhage control with a focused and therefore limited bowel resection.
Source: JAMA
A 63-year-old man visited our hospital because he was undergoing treatment of hepatocellular carcinoma (HCC) in 2007. Multinodular HCC had been detected, and he had been treated 8 times with transcatheter arterial chemoembolization and twice with radiofrequency ablation. In addition, he received endoscopic variceal ligation (EVL) and endoscopic injection therapy due to esophageal varices. Three years after commencing treatment, the patient represented with melena. Bleeding esophageal varices were diagnosed and EVL was performed. At this time, abdominal CT demonstrated multinodular-type HCC in both lobes of the liver, with tumor thrombi in the portal vein. Follow-up upper endoscopy revealed a post-EVL ulcer at the esophagogastric junction (Figure 1). Two months later, upper endoscopy was performed due to slight progression of anemia. Endoscopic examination showed two whitish polypoid masses at the site of EVL (Figure 2a), and a submucosal tumor-like protrusion was recognized on the oral side of the polypoid lesions (Figure 2b). Biopsy specimens obtained from the polypoid mass showed a tumor that was histologically consistent with HCC (Figure 3a) and that was focal positive staining for alphafetoprotein (Figure 3b) and glypican-3 (Figure 3c). After biopsy specimens were taken, argon plasma coagulation was performed at the biopsy site. The patient died of progressive hepatic failure one month later.
HCC is a common malignancy worldwide and extrahepatic metastasis in patients with HCC occurs frequently, in 30–75% of patients. Gastrointestinal involvement is seldom found, in only 4–12% of cases in autopsy series, whereas it has been reported that premortem-diagnosed gastrointestinal tract involvement is found in 0.5–2% of cases. The most commonly involved site was the duodenum, followed by the stomach, the colon, and the jejunum.
Portal blood flow can be reversed by increased intrahepatic resistance and arteriovenous communications in patients with liver cirrhosis associated with HCC, which may cause retrograde metastasis of HCC via the portal system. There are two different hypotheses concerning the way HCC metastasizes to the esophagus: either by direct invasion of the gastrointestinal tract via contiguation between the serosal side of a liver tumor and the esophagus, or via the hematogenous spread of tumor emboli infiltrating via the portal vein system and being disseminated by hepatofugal portal blood flow to the esophagus.
In our patient, the therapy for esophageal varices may have caused the esophageal metastasis of HCC. Tumor emboli in the portal system may have been trapped at the site where the variceal bloodstream was interrupted by EVL, and the metastatic tumor then could have grown and broken through the ulcer base due to EVL. The metastatic tumor from HCC in the esophagus showed a rapid increase in size, and it changed to the appearance of a submucosal mass. As the tumor size increased further, the shape of the esophageal metastasis appeared to change from a submucosal mass to a polypoid mass.
Source: http://onlinelibrary.wiley.com
AIMS65 better predicted mortality and Glasgow-Blatchford better predicted the need for transfusion, but both scoring systems can be helpful in identifying high-risk patients with UGIB.
Investigators recently derived and validated AIMS65 — a new scoring system to predict outcomes for patients with acute upper gastrointestinal bleeding (UGIB) — using a large population of patients from 187 U.S. hospitals (JW Gastroenterol Dec 9 2011).
Now, the researchers have revalidated AIMS65 using data on 278 UGIB patients from a tertiary-care hospital who had a higher severity of disease than that observed in the original population. They also compared the performance of AIMS65 with that of the Glasgow-Blatchford system (GBS; JW Gastroenterol Jul 29 2011) in predicting the primary outcome of inpatient mortality and several secondary outcomes: the composite endpoint of mortality, rebleeding, and endoscopic, radiologic, or surgical intervention; transfusion requirement; intensive care unit admission; rebleeding; length of hospital stay; and the timing of endoscopy.
Overall inpatient mortality was 6.5%. The composite endpoint was seen in 35%. AIMS65 was superior to GBS for predicting mortality (area under the receiver operating curve, 0.93 vs. 0.68; P<0.001), but GBS was superior for predicting the need for transfusion (AUROC, 0.85 vs. 0.65; P<0.01). The two systems were similarly accurate for predicting and other secondary outcomes. GBS values of 10 and 12 maximized the accuracy for predicting mortality and rebleeding, respectively. AIMS65 values of 
2 maximized the accuracy for predicting both outcomes.
Comment: Results of this study from a tertiary-care hospital with expertise in treating patients with upper gastrointestinal bleeding might not be generalizable to other settings. What seems clear from the evidence regarding UGIB scoring systems is that shock, advanced age, and comorbid conditions used in any scoring system can identify patients at high risk for adverse outcomes. However, the issue is not about which system is better; rather, it is about ensuring that some system is used to identify high-risk patients, who will benefit from urgent endoscopy, endoscopic therapy, and more aggressive care, and low-risk patients, who can be treated as outpatients.
Source: Journal Watch Gastroenterology
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