- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02880748
Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy
Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy: a Single-centered, Randomized Controlled Study
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
For WE method, the air pump was turned off for the full duration of insertion to avoid inadvertent air insufflations and colon elongation. Residual air in the lumen was suctioned to minimize angulations at flexures. Water at 37°C was infused with a pump (Olympus) through the biopsy channel to confirm correct tip orientation for scope advancement. The infused water was removed predominantly by suction when the colonoscope was smoothly advanced during the insertion phase, and turbid luminal water due to residual feces was exchanged by clean water until the lumen was clearly visualized. Occasionally, if it was difficult to determine whether the colonoscope tip was in the cecum, air was allowed to be insufflated for observation. If the position of the scope tip was confirmed to be not in the cecum, insufflated air would be removed by suction and the WE method would be continuously used until successful intubation.
For the AI method, water was not used, and air was insufflated during insertion.
Air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal for both methods. Polyps will be removed by forceps biopsy (polyps size <3mm), cold snare technique (3-6mm) or endoscopic mucosal resection (size≥6mm).
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Shaanxi
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Xi'an, Shaanxi, Chiny, 710032
- Rekrutacyjny
- Endoscopic center, Xijing Hospital of Digestive Diseases
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Kontakt:
- Gui Ren, MD
- Numer telefonu: +862984771536
- E-mail: renguigz@hotmail.com
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Główny śledczy:
- Gui Ren, MD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Age 18-80 patients undergoing selective polypectomy
Exclusion Criteria:
- Polyps found more than 6 months
- Patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer
- Patients with history of inflammatory bowel disease
- Patients with planning to undergo Endoscopic Submucosal Dissection(ESD)
- Patients not undergoing standard bowel preparation
- Patients with solid feces in the last stool after bowel preparation
- Patients considered to be high risk for bleeding during Endoscopic mucosal resection (EMR), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy
- Hemodynamically unstable
- Pregnant women
- Unable to provide informed consent
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Water exchange (WE) method
Water exchange (WE) method was used for insertion to the cecum.
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Water exchange (WE) method was used for insertion to the cecum.
And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
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Aktywny komparator: Air insufflation (AI) method
Air insufflation (AI) method was used for insertion to the cecum.
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Air insufflation (AI) method was used for insertion to the cecum.
And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Adenoma miss rate
Ramy czasowe: 12 months
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Adenoma miss rate was calculated as the number of patients with one and more additional adenomas during polypectomy procedure divided by the total number of patients in each group.
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12 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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adenoma-level miss rate
Ramy czasowe: 12 months
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Adenoma-level miss rate was calculated as the number of additional adenomas detected in polypectomy procedure divided by the total number of adenomas in each group.
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12 months
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Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy
Ramy czasowe: 12 months
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Advanced adenoma: any with 3 or more adenomas of any size, 1 or more large adenomas 1 cm, or 1 or more adenomas with villous architecture or highgrade dysplasia.
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12 months
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Adenoma per positive patient (APP)
Ramy czasowe: 12 months
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The mean number of adenoma per positive patient
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12 months
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Quality of Bowel Preparation
Ramy czasowe: 12 months
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The Boston Bowel Preparation Scale (BBPS): cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.
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12 months
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Complication rate
Ramy czasowe: 12 months
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Bleeding, perforation and others
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12 months
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Pain Scores on the Visual Analog Scale compared with previous colonoscopy
Ramy czasowe: 12 months
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0 = no pain, to 10 = most severe pain
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12 months
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Współpracownicy i badacze
Publikacje i pomocne linki
Publikacje ogólne
- Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc. 2010 Oct;72(4):775-81. doi: 10.1016/j.gie.2010.04.030. Epub 2010 Jun 25.
- Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, Dumonceau JM. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Gut. 2016 Mar;65(3):374-89. doi: 10.1136/gutjnl-2015-311110.
- Ren G, Wang X, Luo H, Yao S, Liang S, Zhang L, Dong T, Chen L, Tao Q, Guo X, Han Y, Pan Y. Effect of water exchange method on adenoma miss rate of patients undergoing selective polypectomy: A randomized controlled trial. Dig Liver Dis. 2021 May;53(5):625-630. doi: 10.1016/j.dld.2020.11.012. Epub 2020 Dec 31.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- KY20162059-2
Plan dla danych uczestnika indywidualnego (IPD)
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Badania kliniczne na Water exchange (WE) method
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Avacen, Inc.University of California, San Diego; San Diego Veterans Healthcare SystemZakończonyFibromialgiaStany Zjednoczone