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"Endoscopy, Digestive System - 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
Short-term outcomes of single-incision plus one-port laparoscopic versus conventional laparoscopic surgery for rectosigmoid cancer: a randomized controlled trial
2019
ObjectiveThe objective of the study is to evaluate the short-term outcomes of single-incision plus one-port surgery (SILS + 1) compared with conventional laparoscopic surgery (CLS) for colonic cancer.BackgroundAt present, single-incision laparoscopic colectomy remains technically challenging. The use of SILS + 1 as an alternative has gained increasing attention; however, its safety and efficacy remain controversial.Methods and patientsBetween April 2014 and July 2016, 198 patients with clinical stage T1-4aN0-2 M0 rectosigmoid cancer were enrolled. The participants were randomly assigned to either SILS + 1 (n = 99) or CLS (n = 99). The morbidity and mortality within 30 days, operative and pathologic outcomes, postoperative recovery course, inflammation and immune responses, and pain intensity were compared.ResultsThere was no significant difference in overall complications between the two groups (17.2 vs. 16.3%, P = 1.000). The total operating time for the SILS + 1 group was significantly shorter (100.8 ± 30.4 vs. 116.6 ± 36.6, P = 0.002). Blood loss was significantly greater in the CLS group (20 vs. 50, P < 0.001). Thirteen patients (14%) in the CLS group required additional postoperative analgesics, which was significantly more than four patients in the SILS + 1 group. Notably, on postoperative day three, the visual analogue scale score of the CLS group was greater than that of the SILS + 1 group (1.3 ± 1.1 vs. 1.7 ± 1.3, P = 0.023). Tumor diameter, pathologic stage, length of the proximal and distal margins, and number of lymph nodes harvested were similar, other values were also similar between the two groups.ConclusionOur findings suggest that SILS + 1 might be safe and feasible for rectosigmoid cancer when performed by experienced surgeons. It offers minimal invasiveness without compromising oncologic treatment principles. Trial Registration This trial was registered on ClinicalTrials.gov (NCT02117557).
Journal Article
Transcutaneous electric nerve stimulation of acupuncture points improves tolerance in adults undergoing diagnostic upper gastrointestinal endoscopy: a single-center, double-blinded, randomized controlled trial
by
Chan, Koon Khee
,
Bujang, Mohamad Adam
,
Chuah, Jun Sen
in
Acupuncture
,
Analgesics
,
Clinical trials
2024
BackgroundOesophagogastroduodenoscopy (OGDS) is the most common diagnostic procedure for upper gastrointestinal diseases. It often causes discomfort and anxiety, which are only mitigated by systemic sedation. However, sedation poses additional risks of adverse cardiopulmonary events, increased medical costs, and prolonged recovery. Transcutaneous electrical nerve stimulation of acupuncture points (Acu-TENS) is a non-invasive and innovative approach that induces analgesic effect during endoscopy. This trial is the first to be reported in English that explores the potential of Acu-TENS to increase patient tolerance during non-sedated elective diagnostic OGDS.MethodsA double-blinded randomized controlled trial involving 348 subjects was conducted at a tertiary hospital to evaluate the success rate of OGDS with Acu-TENS. Subjects aged 18–75 years scheduled for their first elective diagnostic OGDS were randomized into the intervention (Acu-TENS) and placebo arms. OGDS success was assessed based on subjects’ satisfaction ratings on a Likert scale and procedure’s technical adequacy. Secondary measures included subjects’ willingness to undergo future OGDS under similar conditions, procedure duration, and the endoscopist’s perceived ease of the procedure.ResultsOGDS success rates were significantly higher with Acu-TENS (77.8%) than with the placebo (68.0%; odds ratio [OR] 1.64, 95% confidence interval [CI] 1.01–2.66, p = 0.043). Subjects who received Acu-TENS expressed higher willingness for future OGDS (78.9%) than those who received the placebo (68.6%; OR 1.71, 95% CI 1.04–2.79, p = 0.031). Procedure duration were significantly shorter in the intervention arm (6.0 min) than in the placebo arm (10.0 min; p = 0.002). No adverse effects were reported, and endoscopists perceived similar procedure ease in both arms.ConclusionsAcu-TENS improved OGDS success and enhanced patients’ experiences during non-sedated OGDS. It demonstrated safety with no side effects and reduced the procedure completion time. It could be used as an adjunct in non-sedated diagnostic OGDS.
Journal Article
A Randomized Comparative Effectiveness Trial of Novel Endoscopic Techniques and Approaches for Barrett’s Esophagus Screening in the Community
by
Wongkeesong, Louis-Michel
,
Shah, Nilay D
,
Katzka, David A
in
Aged
,
Barrett Esophagus - diagnosis
,
Endoscopy, Digestive System - methods
2015
The objective of this study was to compare participation rates and clinical effectiveness of sedated esophagogastroduodenoscopy (sEGD) and unsedated transnasal endoscopy (uTNE) for esophageal assessment and Barrett's esophagus (BE) screening in a population-based cohort.
This was a prospective, randomized, controlled trial in a community population. Subjects ≥50 years of age who previously completed validated gastrointestinal symptom questionnaires were randomized (stratified by age, sex, and reflux symptoms) to one of three screening techniques (either sEGD or uTNE in a mobile research van (muTNE) or uTNE in a hospital outpatient endoscopy suite (huTNE)) and invited to participate.
Of the 459 subjects, 209 (46%) agreed to participate (muTNE n=76, huTNE n=72, and sEGD n=61). Participation rates were numerically higher in the unsedated arms of muTNE (47.5%) and huTNE (45.7%) compared with the sEGD arm (40.7%), but were not statistically different (P=0.27). Complete evaluation of the esophagus was similar using muTNE (99%), huTNE (96%), and sEGD (100%) techniques (P=0.08). Mean recovery times (min) were longer for sEGD (67.3) compared with muTNE (15.5) and huTNE (18.5) (P<0.001). Approximately 80% of uTNE subjects were willing to undergo the procedure again in future. Respectively, 29% and 7.8% of participating subjects had esophagitis and BE.
Mobile van and clinic uTNE screening had comparable clinical effectiveness with similar participation rates and safety profile to sEGD. Evaluation time with uTNE was significantly shorter. Prevalence of BE and esophagitis in community subjects ≥50 years of age was substantial. Mobile and outpatient unsedated techniques may provide an effective alternative strategy to sEGD for esophageal assessment and BE screening.
Journal Article
Barrett’s oESophagus trial 3 (BEST3): study protocol for a randomised controlled trial comparing the Cytosponge-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care patients with chronic acid reflux
2018
Background
Early detection of oesophageal cancer improves outcomes; however, the optimal strategy for identifying patients at increased risk from the pre-cancerous lesion Barrett’s oesophagus (BE) is not clear. The Cytosponge, a novel non-endoscopic sponge device, combined with the biomarker Trefoil Factor 3 (TFF3) has been tested in four clinical studies. It was found to be safe, accurate and acceptable to patients.
The aim of the BEST3 trial is to evaluate if the offer of a Cytosponge-TFF3 test in primary care for patients on long term acid suppressants leads to an increase in the number of patients diagnosed with BE.
Methods
The BEST3 trial is a pragmatic multi-site cluster-randomised controlled trial set in primary care in England. Approximately 120 practices will be randomised 1:1 to either the intervention arm, invitation to a Cytosponge-TFF3 test, or the control arm usual care. Inclusion criteria are men and women aged 50 or over with records of at least 6 months of prescriptions for acid-suppressants in the last year. Patients in the intervention arm will receive an invitation to have a Cytosponge-TFF3 test in their general practice. Patients with a positive TFF3 test will receive an invitation for an upper gastro-intestinal endoscopy at their local hospital-based endoscopy clinic to test for BE.
The primary objective is to compare histologically confirmed BE diagnosis between the intervention and control arms to determine whether the offer of the Cytosponge-TFF3 test in primary care results in an increase in BE diagnosis within 12 months of study entry.
Discussion
The BEST3 trial is a well-powered pragmatic trial testing the use of the Cytosponge-TFF3 test in the same population that we envisage it being used in clinical practice. The data generated from this trial will enable NICE and other clinical bodies to decide whether this test is suitable for routine clinical use.
Trial registration
This trial was prospectively registered with the ISRCTN Registry on 19/01/2017, trial number
ISRCTN68382401
.
Journal Article
Artificial Intelligence as a Surrogate for Inspection Time to Assess Completeness in Esophagogastroduodenoscopy: A Prospective, Randomized, Noninferiority Study
2025
INTRODUCTION:The completeness of esophagogastroduodenoscopy (EGD) is a prerequisite for detecting lesions. This study aims to explore whether the quality of complete examinations assisted by artificial intelligence (AI) would be comparable with those conducted within the guideline-recommended inspection time.METHODS:Patients referred for diagnostic, screening, or surveillance EGD were enrolled at Renmin Hospital of Wuhan University. Patients were randomly assigned to 2 groups in a 1:1 ratio. In the AI-assisted group, endoscopists completed observation of the entire upper gastrointestinal tract with AI assistance. In the control group, endoscopists were instructed to spend no less than 7 minutes on each procedure. The primary outcome was the detection rate of neoplastic lesions. Noninferiority was confirmed when the lower bound of the 95% confidence interval (CI) was greater than the margin of −1.5%.RESULTS:A total of 1,723 patients were prospectively enrolled between July 3, 2023, and April 7, 2024. Seven hundred ninety-six and 763 patients in the AI-assisted and control groups were included in the final analysis, respectively. The detection rates of neoplastic lesions in the AI-assisted and control groups were 3.14% and 2.36%, respectively, resulting in an absolute proportion difference of 0.78% (95% CI −0.58% to 2.14%; odds ratio 1.342 [95% CI 0.726-2.480]). The median inspection time was reduced by 1.5 minutes in the AI-assisted group (6.18 [2.87] vs 7.70 [1.90], P < 0.001).DISCUSSION:Inspection time of complete EGD can be significantly shortened by AI without compromising its quality. These findings provide crucial evidence to support that AI-assisted procedural completeness serves as an objective and effective quality indicator for EGD.
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
Capnographic Monitoring in Routine EGD and Colonoscopy With Moderate Sedation: A Prospective, Randomized, Controlled Trial
by
Kirsh, Brian
,
Kochhar, Gursimran
,
Wang, Yinghong
in
Adult
,
Aged
,
Analgesics, Opioid - administration & dosage
2016
Regulatory changes requiring the use of capnographic monitoring for endoscopic procedures using moderate sedation have placed financial challenges on ambulatory and hospital endoscopy centers across the United States due to the increased cost of training endoscopy personnel and purchasing both capnography-monitoring devices and specialized sampling ports. To date, there has been no published data supporting the use of capnographic monitoring in adult patients undergoing routine endoscopic procedures with moderate sedation. The aim of this randomized, parallel group assignment trial was to determine whether intervention based on capnographic monitoring improves detection of hypoxemia in patients undergoing routine esophagogastroduodenoscopy (EGD) or colonoscopy with moderate sedation.
Healthy patients (ASA Physical Classification (ASAPS) I and II)) scheduled for routine outpatient EGD or colonoscopy under moderate sedation utilizing opioid and benzodiazepine combinations were randomly assigned to a blinded capnography alarm or open capnography alarm group. In both study arms, standard cardiopulmonary monitoring devices were utilized with additional capnographic monitoring. The primary end point was the incidence of hypoxemia defined as a fall in oxygen saturation (SaO2) to <90% for ≥10 s. Secondary outcomes included severe hypoxemia, apnea, disordered respirations, hypotension, bradycardia, and early procedure termination for any cause.
A total of 452 patients were randomized; 218 in the EGD and 234 in the colonoscopy groups; 75 subjects in the EGD group (35.9%) and 114 patients (49.4%) in the colonoscopy group were male, and average body mass index was 27.9 and 29.1 (kg/m(2)), respectively. The blinded and open alarm groups in each study arm were similar in regards to use of opioids and/or benzodiazepines and ASAPS classification. There was no significant difference in rates of hypoxemia between the blinded and open capnography arms for EGD (54.1% vs. 49.5; P=0.5) or colonoscopy (53.8 vs. 52.1%; P=0.79).
Capnographic monitoring in routine EGD or colonoscopy for ASAPS I and II patients does not reduce the incidence of hypoxemia (ClinicalTrials.gov number, NCT01994785).
Journal Article
Operation sequence of bidirectional endoscopy with topical anesthesia affected colonoscopy performance: a randomized controlled trial
2025
Background
The operation sequence of bidirectional endoscopy with topical anesthesia varies among endoscopists, which interferes with clinical procedure. The study aimed to investigate the influence of different operation sequences on the outcomes of quality indicators and improve bidirectional endoscopy performance.
Methods
A randomized trial was conducted at the affiliated hospital of a medical university in China. Outpatients who initially underwent bidirectional endoscopy with topical anesthesia were enrolled. Eligible patients were randomized to either the colonoscopy-first group or the esophagogastroduodenoscopy-first group. Dyclonine hydrochloride mucilage and oxybuprocaine hydrochloride gel were administered for topical anesthesia. After finishing the previous process, the subsequent one was performed immediately. Quality indicators of esophagogastroduodenoscopy and colonoscopy were compared between the groups.
Results
Analyzing 395 combined procedures, the cecal intubation rate, discomfort score during esophagogastroduodenoscopy, examination score of esophagogastroduodenoscopy, and colorectal polyp detection rate were similar between the two groups. The colonoscopy-first group had lower colonic spasm incidence (66.0% vs. 30.3%,
p
< 0.001), shorter median cecal intubation time (254 s vs. 211 s,
p
< 0.001), and higher colonoscopy comfort rate (72.5% vs. 85.6%,
p
< 0.001) compared with the esophagogastroduodenoscopy-first group. Operation sequence significantly affected the incidence of colonic spasm (OR 4.739, 95%CI 3.054–7.352,
p
= 0.000), which correlated with cecal intubation time (r = 0.196,
p
< 0.001) and patient discomfort score (r = 0.136,
p
= 0.007).
Conclusion
In bidirectional endoscopy with topical anesthesia, performing colonoscopy first may improve colonoscopy performance without affecting esophagogastroduodenoscopy examination. The study was registered prior to conducting the research in the Chinese Clinical Trial Registry (
https://www.chictr.org.cn
) on November 7, 2023 with the trial identification number ChiCTR2300077408.
Journal Article