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Lugol chromoendoscopy is essential in detecting and characterizing squamous cell carcinoma of esophagus. Esophageal irritating symptom has been reported as an common adverse event, which could be alleviated by sodium thiosulfate solutions. However, sodium thiosulfate was not widely available. N-acetylcysteine has been previously used as a mucolytic reagent, we propose that it may also be used to alleviate irritating symptoms caused by Lugo's chromoendoscopy. A prospective, non-inferior, randomized double-blind clinical trial was designed to study the efficacy of N-acetylcysteine solutions in relieving esophageal discomfort .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sodium thiosulfate solution arm | Active Comparator | 20ml of 5% sodium thiosulfate solution were prepared with 1g sodium thiosulfate crystal dissolved in normal saline in a 20 ml syringe |
|
| N-acetylcysteine solution arm | Experimental | 20ml of 3% N-acetylcysteine solution were prepared with one piece of N-acetylcysteine effervescent tablet ( net weight 0.6g )dissolved in normal saline in a 20 ml syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine solution | Drug | use N-acetylcysteine solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Visual analogue scale change | Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy | 30 minute after endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with symptom | The percentage of patients with symptom after Lugol chromoendoscopy for certain time | 5 minute or 30 minute or 24 hour after endoscopy |
| Neutralization rate | Neutralizing effect for residual iodine in esophagus and stomach |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaohua Zhu | Xijing Hospital of Digestive DIsease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Disease | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11174292 | Background | Kondo H, Fukuda H, Ono H, Gotoda T, Saito D, Takahiro K, Shirao K, Yamaguchi H, Yoshida S. Sodium thiosulfate solution spray for relief of irritation caused by Lugol's stain in chromoendoscopy. Gastrointest Endosc. 2001 Feb;53(2):199-202. doi: 10.1067/mge.2001.110730. | |
| 31669091 | Background | Gotoda T, Kanzaki H, Okamoto Y, Obayashi Y, Baba Y, Hamada K, Sakae H, Abe M, Iwamuro M, Kawano S, Kawahara Y, Okada H. Tolerability and efficacy of the concentration of iodine solution during esophageal chromoendoscopy: a double-blind randomized controlled trial. Gastrointest Endosc. 2020 Apr;91(4):763-770. doi: 10.1016/j.gie.2019.10.022. Epub 2019 Oct 25. |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| sodium thiosulfate solution | Drug | use sodium thiosulfate solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy |
|
| During endoscopy |
| Heart rate variability | the percentage of heart rate change 5 min or 30 min compared to that Before endoscopy | 5 minute or 30 minute after endoscopy |
| Severe discomfort rate | the percentage of patient with Visual analogue scale over 4 | 5 minute or 30 minute after endoscopy |
| exam time | the time of endoscopy from the beginning of spraying diluted Lugol's solution to end of endoscopy minus time required for biopsy. | during endoscopy |
| 34371004 | Derived | Guo Q, Fan X, Zhu S, Zhao X, Fang N, Guo M, Liu Z, Han Y. Comparing N-acetylcysteine with sodium thiosulfate for relieving symptoms caused by Lugol's iodine chromoendoscopy: a randomized, double-blind trial. Gastrointest Endosc. 2022 Feb;95(2):249-257. doi: 10.1016/j.gie.2021.07.025. Epub 2021 Aug 8. |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |