Endoscopic clip for delayed bleeding after endoscopic papillectomy

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0003245
• Lead Sponsor: Hallym University Medical Center-Dongtan

Brief Summary

Study population and baseline characteristics A total of 80 patients who underwent endoscopic papillectomy were assessed for eligibility. After randomization, two patients in the no-clipping group were excluded from the study: one patient declined to participate, and one patient was younger than 18 years by a few days. Finally, the remaining 78 patients received their allocated intervention, and none were lost to follow-up or excluded. The median age was 59.5 and 60.0 years in the clipping and no-clipping groups, respectively. The proportion of male patients did not differ between the groups. However, the median body mass index was significantly higher in the no-clip-ping group than in the clipping group (26.0 [95 % confidence interval (CI) 23.9–28.0] vs. 24.3 [95 %CI 21.6–27.1]). Labora-tory findings did not differ between groups. Procedure-related findings Total procedure time did not differ between the clipping and no-clipping groups (21.5 minutes [95%CI 15.0–28.5] vs. 21.0 minutes [95%CI 14.0–28.0]) (Table 1 s in the online-only Sup-plementary material). The median size of lesions and other pro-cedure-related factors did not differ in either group. Submuco-sal injection was performed in 85.0 % (95 %CI 70.9–92.9) of pa-tients in the clipping group and 92.1% (95 %CI 79.2–97.3) of patients in the no-clipping group, without significant differ-ence. Furthermore, biliary and pancreatic stents were placed in similar proportions in each group. Clinical outcomes and adverse events The incidence of delayed bleeding as the main outcome was numerically higher in the no-clipping group than in the clipping group; however, the difference did not reach statistical significance (31.6 % [95 %CI 19.1–47.5] vs. 15.0 % [95 %CI 7.1–29.1]) (?Table 2). The incidence of immediate bleeding was similar between the groups (clipping vs. no-clipping: 5.0 % [95 %CI 1.4–16.5] vs. 7.9% [95%CI 2.7–20.8]), and all cases were mild in severity. Three cases of immediate bleeding in the no-clipping group underwent placement of several clips for hemostasis and bleeding wase successfully controlled. The en bloc and complete resection rates were similar between the groups. Furthermore, detailed pathologic results including margin and ductal involvement did not differ between the groups. The most common final pathologic result of the resected specimens was low grade dysplasia. The overall incidence of PEP in the total cohort was 11.5 % (9/78), and did not differ significantly between the groups (clipping vs. no-clipping: 17.5% [95%CI 8.7–31.9] vs. 5.3% [95%CI 1.5–17.3]); the severity was mild in all patients. No other major adverse events, such as perforation or post-papillectomy acutecholangitis, were reported in either group.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-04-20
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

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

(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.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the incidence of delayed bleeding at more than 4 hours after EP

Secondary Outcome Measures

Name	Time	Method
technical success rate;Incidence rate of post-ERCP pancreatitis;Incidence rate of Acute cholangitis;Total procedure time