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

JRCT ID: jRCT1042190024

Registered date:28/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Postoperative reconstructed intestinal tract: biliary tract disease with surgically altered GI anato
• Date of first enrollment: 08/06/2019
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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 before examination
A blood test was conducted before the examination.
Inspection items (red blood cell count, white blood cell count, platelet count, amylase, CRP, hepatobiliary enzyme, BUN, Cr)
4(1) After fasting, secure all instances of drip infusion, sedate in Pressedex and Midazolam and maintain. Maintain appropriate sedation using Midazolam, Sosegon as appropriate during the examination.
(2) The scope uses a double balloon endoscope. When inserting the endoscope, Roux-en Y leg, Braun If it is past the anastomotic section, if it is a visual examination, insert it in the direction expected to be import leg by the judgment of the operator as before. If CO2 group, use CO2 air supply, advance the endoscope while confirming the direction of travel on the perspective screen.
(3) Record the endoscope insertion time, total examination time, endoscopic findings, body findings (blood pressure, SpO2, heart rate). Use the fluoroscopic image as appropriate to check the insertion condition and the direction of movement of the endoscope.
analysis
Rouxen Y leg, Braun Anatomical area of initial imported leg selectivity is stratified and compared between CO2 group and visual group.
The CO2 group and the visual group are stratified and compared for the insertion time to the duodenal papilla in the reconstructed intestinal tract or the biliary jejunum anastomosis section.
Stratification factor
1 operation
(1)Rouxen Y method (with gastric surgery)
(2) Rouxen Y method (without stomach surgery)
(3) Billroth2 method
2 enforcer
(1) DBERC enforcement history 5 years or more
(2) DBERC enforcement history Less than 5 years

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Nakamura Masanao
• Source(s) of Monetary Support: Medical development expenses (requirement 3)