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prospective interventional study compare between Carbon dioxide insufflation method and conventional visual confirmation method for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with surgically altered GI anatomy

prospective interventional study compare between Carbon dioxide insufflation method and conventional visual confirmation method for endoscopic retrograde cholangiopancreatography using double-balloon endoscopy in patients with surgically altered GI anatomy - Carbon dioxide insufflation method in DBERC

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042190024
Enrollment
50
Registered
2019-04-28
Start date
2019-06-08
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Postoperative reconstructed intestinal tract: biliary tract disease with surgically altered GI anato intestinal tract after surgery reconstruction

Interventions

1. Obtain written consent to this research in advance on hospitalization day 2. Patients are stratified according to background factor and randomly assigned to CO2 group and visual group. 3. The day b

Sponsors

Nakamura Masanao
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Target disease: Age: over 20 years old (2) patients have consent in writing on this research (3) patients have biliary pancreatic disease (suspect) with intestinal tract after surgery reconstruction

Exclusion criteria

Exclusion criteria: (A) Patients with acute abdomen disease (B) Patients with severe acute inflammation (C) pregnant patient (D) If the general condition is very poor, ileus, intestinal perforation, pancreatitis, respiratory diseases, cardiovascular diseases, acquired hemophilia, stenosis, large ulcers, tumors endoscope that the risk of performing tests such as Patients with utility benefits (E) Patients taking antithrombotic drugs or insufficiently withdrawal (F) Patients with severe dysfunction in heart, lung, kidney and liver (G) Patients with bradycardia and atrioventricular block (H) Patients who have participated in the study (I) Others, patients judged inappropriate by the attending physician

Design outcomes

Primary

MeasureTime frame
Presence or absence of significant differences in the initial import leg selection rate in the Roux-en Y leg, Braun anastomoses in the CO 2 -use group and the visual group

Secondary

MeasureTime frame
Insertion time to the duodenal papilla of the reconstructed intestinal tract or bile duct jejunum anastomosis Other evaluation items (1)Presence or absence of endoscopic treatment (2)Total inspection time (3)accident caused by endoscopic examination

Contacts

Public ContactKentaro Murate

Nagoya University Graduate School of Medicine

km1219@med.nagoya-u.ac.jp+81-52-741-2172

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026