ampullary tumor
Conditions
Interventions
NKF group:needle-knife fistulotomy (NKF)
CCM group:conventional cannulation method (CCM)
Sponsors
Department of gatroenterology,The First Affiliated Hospital, Jiangxi Medical College, Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Those who require endoscopic retrograde cholangiopancreatography (ERCP) for ampullary tumors, e.g., in combination with cholangitis, symptomatic jaundice (itching), or prior to neoadjuvant chemotherapy; 2. Those who need palliative biliary drainage for inoperable ampullary tumors; 3. Those who are at high risk of surgical intervention or refuse to undergo surgical intervention; 4. Ampullary tumors with a raised portion (Figure 1), with the main body structure remaining, that have been evaluated by two experienced ERCP operators and unanimously determined to be suitable for needle-knife fistulotomy (NKF); 5. More than 18 years old; 6. Voluntary participation and informed consent.
Exclusion criteria
Exclusion criteria: 1. Complete destruction of the primary papilla, making it unsuitable for NKF (Figure 2); 2. Contraindications to ERCP (platelets less than 100 x 10^9/L, international normalized ratio greater than 1.5; severe cardiopulmonary disease, etc.); 3. Combined duodeno-papillary biliary fistula; 4. Reconstructive surgery of the digestive tract; 5. Inability to discontinue anticoagulants and antiplatelet agents; 6. Intellectual disability that prevents normal communication 7. Allergy to the contrast media under study; 8. Previous ERCP or EST; 9. Pregnancy or lactation; 10. Not fit for the study judged by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of successful cannulation; | — |
Secondary
| Measure | Time frame |
|---|---|
| time of cannulation;time of operation;rate of difficult cannulation;Adverse event rates;incidence of bleeding;incidence of perforation;Incidence of cholangitis;incidence of cholecystitis; | — |
Countries
China
Contacts
Public ContactJunbo Hong
Department of gatroenterology,The First Affiliated Hospital, Jiangxi Medical College, Nanchang University
Outcome results
None listed