Endoscopic clip for delayed bleeding after endoscopic papillectomy

Efficacy and safety of preventive hemoclipping for delayed hemorrhage after endoscopic papillectomy: A randomized prospective multicenter study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003245

Enrollment

Registered

2018-10-05

Start date

2018-10-24

Completion date

Unknown

Last updated

2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Endoscopic procedures All endoscopic retrograde cholangiopancreatography procedures will be performed by endoscopists (T.J.S., S.W.P., J.S.P., T.Y.P., and J.H.C.) with previous experi

Boston Scientific, Natick, MA, USA) and constant tension will be applied. A blended current (Endocut Q mode, effect 3, duration 2, interval 5) in the electrosurgical unit (VIO 300D

ERBE, Tubingen, Germany) will be used to transect the lesion. Initially, en-bloc resection will be attempted in all patients

however, in cases of large adenomas or grossly remnant lesions after the first snaring, piecemeal resection will be carried out. Endoscopic sphincterotomy and common bile duct (CBD) stent insertion (e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult patients aged 18 years or older 2) Biopsy-proven and morphologically benign-looking adenomas (low grade dysplasia) on major papilla 3) No evidence of ductal invasion on computed tomography, magnetic resonance imaging and endoscopic ultrasonography

Exclusion criteria

Exclusion criteria: (1) evidence of ductal invasion on preoperative imaging modality including computed tomography (CT), magnetic resonance image (MRI), or endoscopic ultrasonography (EUS) (2) patients who had biopsy-proven high-grade dysplasia/focal carcinoma, or morphologically evidence of carcinoma (presence of firmness, ulceration, induration, friability, or positive non-lifting sign with submucosal injection) (3) if the patient had cardiopulmonary instability (4) if the coagulation parameters were abnormal (international normalized ratio >1.5 or platelet count <50,000 cells/cmm3) (5) postponing the antithrombotic therapy was impossible (6) pregnancy (7) if the patient refused to participate in the study or provide informed consent.

Design outcomes

Primary

Measure	Time frame
the incidence of delayed bleeding at more than 4 hours after EP	—

Secondary

Measure	Time frame
technical success rate;Incidence rate of post-ERCP pancreatitis;Incidence rate of Acute cholangitis;Total procedure time	—

Countries

Korea, Republic of

Contacts

Public ContactSe Woo Park

Hallym University Medical Center-Dongtan

britnepak@outlook.com+82-31-8086-2858

Outcome results