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"Endoscopy - methods"
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The Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Double-Blind Randomized Controlled Trial
by
Pittayanon, Rapat
,
Vimonsuntirungsri, Thanrada
,
Nopjaroonsri, Papatsakorn
in
Adult
,
Aged
,
Antibiotics
2024
INTRODUCTION:The 2021 American College of Gastroenterology Guidelines suggested using of intravenous erythromycin before endoscopy in patients with upper gastrointestinal bleeding (UGIB) to enhance endoscopic view and reduce the need for repeat endoscopy. Evidence on intravenous metoclopramide, which is more accessible, is scant, especially in patients with active UGIB. This study aimed to evaluate the efficacy of metoclopramide for gastric visualization in patients with active UGIB.METHODS:Between April 10, 2021, and October 8, 2022, this double-blind, double-center randomized controlled trial enrolled patients with active UGIB (hematemesis or presence of fresh blood in the nasogastric tube). The eligible patients were randomly assigned in a concealed 1:1 allocation to metoclopramide or placebo. The primary outcome was adequate visualization by objective endoscopic visualized gastroduodenal scores (EVS). Secondary outcomes included mean difference in EVS, duration of esophagogastroduodenoscopy (EGD), immediate hemostasis, need for a second look EGD, units of blood transfusion, length of hospital stay, and 30-day rebleeding rate.RESULTS:Of the 68 eligible patients, 3 of each group were excluded by protocol violation. Finally, 62 patients (31 metoclopramide and 31 placebo) were analyzed. The percentage of patients with adequate visualization in metoclopramide and placebo group was 77.4% and 61.6% (odds ratio [OR] 2.16 [0.71-6.58], P = 0.16). The need for a second look EGD in the 72 hours was lower in the metoclopramide group (3.2% vs 22.6%, OR 0.11 [0.01-0.99], P = 0.02), whereas the other secondary outcomes were not different. However, in gastric lesions subgroup analysis, metoclopramide improved the adequate visualization rate (92.9% vs 50%, OR 13 [1.32-128.10], P = 0.03) and mean EVS at fundus (1.79 ± 0.42 vs 1.29 ± 0.72; P = 0.03).DISCUSSION:Metoclopramide did not improve endoscopic visualization but decreased the need for second look EGD in patients with overall active UGIB. It improved gastric visualization in those with UGIB due to gastric lesions, primarily by improving visualization in the fundus (ClinicalTrials.gov number NCT04771481).
Journal Article
Choice of colon capsule or colonoscopy versus default colonoscopy in FIT positive patients in the Danish screening programme: a parallel group randomised controlled trial
by
Bjørsum-Meyer, Thomas
,
Thygesen, Marianne Kirstine
,
Kroijer, Rasmus
in
Cancer
,
Colonoscopy
,
Colorectal cancer
2025
BackgroundColonoscopy is among the standard tests for colorectal cancer (CRC) screening. However, uptake varies, and alternatives such as colon capsule endoscopy (CCE) are available. The uptake and detection rate of clinically significant neoplasia with CCE, compared with colonoscopy, remain unclear in this setting.ObjectiveThe primary objective of this study was to compare the detection rates of advanced neoplasia between CCE and colonoscopy, using a pathway in which the study group could choose between the two procedures, while the control group was offered only colonoscopy.DesignA randomised, intention-to-treat trial was conducted among Danish CRC screening participants who tested positive with a faecal immunochemical test (FIT). The trial compared the detection rate of advanced neoplasia (primary outcome) and the uptake rate of both approaches between the two arms.ResultsA total of 473 684 invitations were sent to 396 676 individuals, with 62.6% returning the test. Among them, 11 075 tests were positive (4.5%), with no significant differences between the two study groups. Among FIT-positive cases, the uptake for colonoscopy was 91.1% in the control arm and 91.7% in the study arm, where participants had a choice of methods. In the study arm, 45.8% preferred CCE, 11.4% preferred colonoscopy and 42.8% had no preference and underwent colonoscopy. Ultimately, 69.9% of patients who initially opted for CCE were later referred for colonoscopy. The rate of advanced neoplasia detection was similar between the groups: 0.67% in the study arm versus 0.64% in the control arm.ConclusionOffering CCE as an alternative to colonoscopy did not significantly alter the detection rate of advanced neoplasia, nor did it increase uptake in a screening programme with high adherence to colonoscopy following a positive FIT test. Instead, it led to a very high rate of secondary colonoscopies. Therefore, CCE cannot be recommended in this setting.Trial registration numberNCT04049357 (ClinicalTrials.gov)
Journal Article
Prospective clinical trial of traction device-assisted endoscopic submucosal dissection of large superficial colorectal tumors using the S–O clip
2014
Background
Endoscopic submucosal dissection (ESD) allows en bloc resection of superficial colorectal tumors regardless of size. However, ESD is technically difficult, hazardous, and time consuming. New devices may help overcome these drawbacks. We focused on traction methods and designed a new traction device, the “S–O clip.” Its main advantage is that it allows direct visualization of the cutting line during submucosal dissection. Moreover, it can be used at any location without withdrawing the endoscope. The purpose of this study was to evaluate the efficacy and safety of traction device-assisted ESD for large colorectal tumors using the S–O clip.
Methods
Between August 2010 and December 2011, ESD was performed in 70 patients with a superficial colorectal tumor ≥20 mm in diameter in our department. Patients were randomized into two groups: 27 cases in the S–O clip-assisted ESD group and 23 cases in the conventional ESD group. Included in the analysis were patient’s gender and age, tumor form, size, and location, rate of en bloc resection, procedure time, presence or absence of intraoperative perforation or delayed bleeding, and pathological findings. Subgroup analysis stratified by these factors and multivariate analyses were conducted.
Results
In the S–O clip-assisted ESD group, all 27 tumors were resected en bloc without any complications. Although a micro perforation occurred in one patient in the conventional ESD group, further surgical treatment was not required. None of the other 22 cases in the conventional ESD group experienced complications. The mean procedure time for the S–O clip-assisted ESD group was significantly shorter than for the conventional ESD group (37.4 ± 32.6 vs. 67.1 ± 44.1 min,
p
= 0.03). No significant between-group differences were found for the other factors.
Conclusion
Our results demonstrated that S–O clip-assisted ESD is safe and fast for en bloc resection of large superficial colorectal tumors.
Journal Article
Bilateral Spinal Decompression of Lumbar Central Stenosis with the Full-Endoscopic Interlaminar Versus Microsurgical Laminotomy Technique: A Prospective, Randomized, Controlled Study
2015
Background: Extensive decompression with laminectomy, where appropriate, is often still described as the method of choice when operating on degenerative lumbar spinal stenosis. Nonetheless, tissue-sparing procedures are becoming more common. Endoscopic techniques have become the standard in many areas because of the surgical advantages they offer and the benefits for rehabilitation. One key issue when operating on the spine was the development of instruments to provide sufficient bone resection under continuous visual control. This was achieved by using endoscopes for operations carried out in cases of spinal canal stenosis. Objective: This study of patients with degenerative lumbar central spinal stenosis compares the results of spinal decompression using the full-endoscopic interlaminar technique (FI) with a conventional microsurgical laminotomy technique (MI). Study Design: Prospective, randomized, controlled study. Settings: 135 patients with microsurgical or full-endoscopic decompression were followed up for 2 years. Alongside general and specific parameters, the following measuring instruments were also used for the investigation: Visual Analog Scale (VAS), German version of the North American Spine Society Instrument (NASS), Oswestry Low-Back-Pain-Disability Questionnaire (ODI). Results: Postoperatively 72 % of the patients no longer had leg pain or the pain was almost completely reduced and 21.2 % experienced occasional pain. The clinical results were the same in both groups. The rate of complications and revisions was significantly reduced in the FI Group. The full-endoscopic techniques brought advantages in the following areas: operation, complications, traumatization, rehabilitation. Limitations: Lack of placebo control group. Conclusions: The recorded results demonstrate that the full-endoscopic interlaminar bilateral decompression adopting a unilateral approach provides an adequate and safe supplement and alternative to the conventional microsurgical bilateral laminotomy technique when the indication criteria are fulfilled. At the same time, it offers the advantages of a minimally invasive intervention. Key words: Spinal stenosis, central stenosis, spinal decompression, endoscopic spinal decompression, minimally invasive spine surgery
Journal Article
Minimally invasive surgeries for spontaneous hypertensive intracerebral hemorrhage (MISICH): a multicenter randomized controlled trial
2024
Background
Intracerebral hemorrhage (ICH) is a common stroke type with high morbidity and mortality. There are mainly three surgical methods for treating ICH. Unfortunately, thus far, no specific surgical method has been proven to be the most effective. We carried out this study to investigate whether minimally invasive surgeries with endoscopic surgery or stereotactic aspiration (frameless navigated aspiration) will improve functional outcomes in patients with supratentorial ICH compared with small-bone flap craniotomy.
Methods
In this parallel-group multicenter randomized controlled trial conducted at 16 centers, patients with supratentorial hypertensive ICH were randomized to receive endoscopic surgery, stereotactic aspiration, or craniotomy at a 1:1:1 ratio from July 2016 to June 2022. The follow-up duration was 6 months. Patients were randomized to receive endoscopic evacuation, stereotactic aspiration, or small-bone flap craniotomy. The primary outcome was favorable functional outcome, defined as the proportion of patients who achieved a modified Rankin scale (mRS) score of 0–2 at the 6-month follow-up.
Results
A total of 733 patients were randomly allocated to three groups: 243 to the endoscopy group, 247 to the aspiration group, and 243 to the craniotomy group. Finally, 721 patients (239 in the endoscopy group, 246 in the aspiration group, and 236 in the craniotomy group) received treatment and were included in the intention-to-treat analysis. Primary efficacy analysis revealed that 73 of 219 (33.3%) in the endoscopy group, 72 of 220 (32.7%) in the aspiration group, and 47 of 212 (22.2%) in the craniotomy group achieved favorable functional outcome at the 6-month follow-up (
P
= .017). We got similar results in subgroup analysis of deep hemorrhages, while in lobar hemorrhages the prognostic outcome was similar among three groups. Old age, deep hematoma location, large hematoma volume, low preoperative GCS score, craniotomy, and intracranial infection were associated with greater odds of unfavorable outcomes. The mean hospitalization expenses were ¥92,420 in the endoscopy group, ¥77,351 in the aspiration group, and ¥100,947 in the craniotomy group (
P
= .000).
Conclusions
Compared with small bone flap craniotomy, endoscopic surgery and stereotactic aspiration improved the long-term outcome of hypertensive ICH, especially deep hemorrhages.
Trial Registration
ClinicalTrials.gov Identifier: NCT02811614.
Journal Article
Safety and efficacy of cipepofol for painless digestive endoscopy in older patients: a randomized, double-blind, non-inferiority trial
2025
Background
Cipepofol, a novel anesthetic agent, may offer advantages for older patients undergoing painless digestive endoscopy. This study evaluated the safety and efficacy of this approach compared to a combination of etomidate and propofol (EP).
Methods
In this single-center, double-blind, randomized, non-inferiority trial, 120 older patients(aged 65–90 years) undergoing painless gastroscopy or colonoscopy were randomized to receive either cipepofol (0.3–0.4 mg/kg;
n
= 60) or EP (1:1 ratio, 0.15–0.2 mL/kg;
n
= 60). Primary outcomes included sedation duration. Secondary outcomes assessed sedation success, recovery time, discharge readiness, adverse events, and hemodynamic stability.
Results
All patients achieved successful sedation (100%). Initial sedation duration was comparable between the cipepofol and EP groups (8.73 [5.10, 10.18] vs. 7.41 [5.35, 9.09] minutes;
p
= 0.165). Recovery times were similar (5.49 [3.51, 7.62] vs. 4.86 [3.36, 8.86] minutes;
p
= 0.819), while discharge readiness was faster in the cipepofol group (1.67 [0.78, 2.38] vs. 2.96 [1.21, 7.23] minutes;
p
= 0.002). Adverse events, including hypotension, bradycardia, and hypoxia, were comparable. Injection pain occurred only in the EP group (5%).
Conclusion
In older patients undergoing painless digestive endoscopy, cipepofol is non-inferior to the etomidate-propofol combination in sedation duration and safety. It also shares the characteristic of stable hemodynamics and offers advantages, including reduced injection pain and a shorter time to meet discharge criteria, providing a simplified choice for clinical practice.
Trial registration
ChiCTR2400088889, Date of Registration: 2024-08-28,
https://www.chictr.org.cn/showproj.html?proj=212632
.
Journal Article
Pre-medication with simethicone and N-acetyl cysteine for improving mucosal visibility during upper gastrointestinal endoscopy: A randomized controlled trial
by
Reddy, Rithesh
,
Goud, Rajesh
,
Reddy, Praveen
in
Acetylcysteine - administration & dosage
,
Adult
,
Double-Blind Method
2024
Background and Aim
Diagnostic performance of esophagogastroduodenoscopy (EGD) may be compromized due to adherent mucus and foam. In this study, we aimed at assessing the impact of premedication on mucosal visibility during endoscopy.
Methods
This is a double-blinded (patient and investigator), randomized trial conducted at a tertiary care centre. Patients were randomized into four groups: A (water), B (simethicone [S]), C (N-acetyl cysteine [NAC]), D (S + NAC). Premedication solutions were administered 10-30 minutes before endoscopy and mucosal visibility graded from 1 (best) to 4 (worst) (1 best, 4 worst). Total mucosal visibility scores (TMVS) from six sites ranged from 6 (best) to 24 (worst) points. The primary outcome of study was comparison of TMVS between simethicone and combination (S + NAC) premedication groups. Secondary outcomes were adverse events and impact of endoscopy timing on TMVS.
Results
Total 800 patients (39 years, 68.8% males) were randomized into four groups. Median TMVS were significantly lower in groups B (7 [6-8]) and D (8 [6-9]) as compared to A (11 [9-13]) and C (10 [8-12]). Proportion of cases with adequate gastric mucosal visibility (score < 7) was 26% in group A, 71% in group B, 36% in group C and 79% in group D. There was no difference in TMVS in groups A and C (
p
= 0.137). TMVS were significantly lower in late (> 20-30 minutes) vs. early (10–20 minutes) endoscopy sub-group (8 [7–11] vs, 9 ([7–11],
p
= 0.001). However, TMVS were similar between group B and group D in early endoscopy group (
p
= 0.451). There was no significant difference in the lesion detection rate among the different premedication drugs (
p
> 0.05).
Conclusions
Premedication with simethicone or combination (simethicone and NAC) significantly improves mucosal visibility during EGD. If early endoscopy is indicated, simethicone provides similar mucosal visibility and may be an effective alternative to combined premedication.
Trial registration
NCT05951712.
Graphical abstract
Journal Article
Advancing artificial intelligence applicability in endoscopy through source-agnostic camera signal extraction from endoscopic images
by
Kafetzis, Ioannis
,
Hüneburg, Robert
,
Zoller, Wolfram G.
in
Algorithms
,
Annotations
,
Artificial Intelligence
2025
Successful application of artificial intelligence (AI) in endoscopy requires effective image processing. Yet, the plethora of sources for endoscopic images, such as different processor-endoscope combinations or capsule endoscopy devices, results in images that vastly differ in appearance. These differences hinder the generalizability of AI models in endoscopy.
We developed an AI-based method for extracting the camera signal from raw endoscopic images in a source-agnostic manner. Additionally, we created a diverse dataset of standardized endoscopic images, named Endoscopic Processor Image Collection (EPIC), from 4 different endoscopy centers. Included data were recorded using 9 different processors from 4 manufacturers with 45 endoscopes. Furthermore, images recorded with 4 capsule endoscopy devices from 2 manufacturers are included. We evaluated the camera signal extraction method using 641 manually annotated images from 5 different, publicly available endoscopic image datasets, as well as on the EPIC dataset. Results were compared it with a published baseline in terms of Intersection over Union (IoU) and Hausdorff distance (HD).
In segmenting the camera signal on images from public datasets, our method achieved mean IoU of 0.97 which was significantly higher than that of the baseline method and mean HD of 21 pixels which was significantly lower compared to the baseline. On the standardized images of the EPIC dataset, there was no significant difference between IoU but our method achieved a significantly lower HD. Both the developed AI-based method and the generated dataset are made publicly available.
This work introduces an AI-based method that effectively segments the endoscope camera signal from the raw endoscopic data in a source-agnostic way. Utilizing the proposed method as a preprocessing step allows existing AI models to use any endoscopic image, independent of its source, without compromising performance. Additionally, EPIC, a dataset of diverse endoscopic images, is generated. The proposed method, trained AI model weights, and the EPIC dataset are made publicly available.
Journal Article
A randomised controlled trial of transforaminal endoscopic discectomy vs microdiscectomy
by
Subramanian, Ashok S.
,
Scott, Chloe E. H.
,
Gibson, J. N. Alaistair
in
Adult
,
Aged
,
Diskectomy - methods
2017
Purpose
Transforaminal endoscopic discectomy (TED) minimises paraspinal muscle damage. The aim of this trial was to compare clinical outcomes of TED to Microdiscectomy (Micro).
Methods
143 patients, age 25–70 years and <115 kg, with single level lumbar prolapse and radiculopathy, were recruited and randomised. 70 received TED under conscious sedation and 70 Micro under general anaesthesia. Oswestry Disability Index (ODI), visual analogue scores (VAS) of back and leg pain, and Short Form Health Survey indices (SF-36) were measured preoperatively and at 3, 12 and 24 months.
Results
All outcome measures improved significantly in both groups (
p
< 0.001). Affected side leg pain was lower in the TED group at 2 years (1.9 ± 2.6 vs 3.5 ± 3.1,
p
= 0.002). Hospital stay was shorter following TED (0.7 ± 0.7 vs 1.4 ± 1.3 days,
p
< 0.001). Two Micro patients and five TED patients required revision giving a relative risk of revision for TED of 2.62 (95% CI 0.49–14.0).
Conclusions
Functional improvements were maintained at 2 years in both groups with less ongoing sciatica after TED. A greater revision rate after TED was offset by a more rapid recovery.
Journal Article
A novel method of cardia visualization and comfort level enhancement during magnetic capsule gastroscopy via sugar-glued tether-assisted technique: a randomized pilot study inspired by a Chinese snack-making process (with video)
2024
BackgroundMagnetic capsule gastroscopy (MCG) is a non-invasive diagnostic method for the digestive tract. However, its efficiency in visualizing the gastric cardia is often compromised due to the capsule’s rapid passage. This study introduces a novel sugar-glued tether-assisted technique inspired by a traditional Chinese snack-making process to enhance cardia visualization and patient comfort during MCG.MethodsThis pilot, open-label, single-center, randomized controlled, non-inferiority study was conducted at Binzhou Medical University Hospital. Seventy-eight patients were enrolled and divided into three groups: conventional MCG, suction cup tether-assisted MCG, and sugar-glued tether-assisted MCG. The primary outcomes included safety, comfort level, and gastric cardia visualization quality. Secondary outcomes assessed technique-associated performance and clinical factors.ResultsThe sugar-glued tether-assisted MCG demonstrated comparable cardia visualization quality to the suction cup method, with significantly better results than conventional MCG. Comfort levels were significantly higher in the sugar-glued group compared to the suction cup group. The number of swallow attempts was significantly lower in the sugar-glued group, with no adverse events reported. Secondary outcomes showed no significant differences in MCG assembly time and ingestion-to-detachment period between the suction cup and sugar-glued groups.ConclusionThe sugar-glued tether-assisted MCG is a feasible and safe modification that enhances gastric cardia visualization while improving patient comfort. This technique provides a cost-effective alternative to the suction cup method, warranting further investigation in larger, multi-center studies.
Journal Article