Laparoscopic Kasai Has Similar Anesthetic Outcomes to Open Kasai

Biliary Atresia Clinical Trial

Official title:

Laparoscopic Kasai Portoenterostomy Has Similar Surgical Outcomes and Better Urine Output Compared to Standard Open Kasai- Portoenterostomy: A Ten-year Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06163417
• Other study ID #: CE22128A
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: March 28, 2023

Study information

• Verified date: November 2023
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Biliary atresia (BA) is a rare biliary tree disease with a high incidence in eastern Asia. Kasai operation is a standard treatment for BA, and studies have shown that timely Kasai operation is crucial for better outcomes. The Kasai operation can be performed as either an open or laparoscopic technique. This study aimed to compare the differences in anesthetic management between the two surgical groups. Herein, we compared the outcomes of infants with BA who underwent the open and laparoscopic Kasai surgery.

Description:

Biliary atresia is (BA) a rare biliary tree disease. This disease, which is usually found in infancy is characterized by biliary inflammation and obliteration. The incidence variate from 1 in 5000 to 20000. However, high prevalence rate up to 1 in 5-10,000 was comparatively noted in eastern Asia, especially in Japan and Taiwan. Biliary atresia can be treated by "Kasai operation" ( Kasai portoenterotomy) or liver transplantation. In the previous study, 60% of biliary atresia patients after receiving Kasai portoenterostomy could have better liver prognosis.The timing of Kasai operation is also crucial, increased age of surgery had negative influence in the long-term follow up.

Traditionally, Kasai portoenterostomy was performed by open surgery. As the progression and popularity of minimally invasive surgery, laparoscopic Kasai was first introduced in 2002 and then performed in many countries. However, the advantage of laparoscopic Kasai seems still controversial due to many indicative outcomes as early jaundice clearance, native liver survival (NLS) and liver transplantation rate within 1 year after the Kasai operation even adhesions prevention seems no better maybe worse in laparoscopic group.But in our hospital, no statistically significant differences were observed for hospital stay and outcomes (including early jaundice clearance rate, episodes of cholangitis, and 2-year native liver survival rate) between the open and the laparoscopic Kasai operations.Even the better operation view was noted in laparoscopic group but operation time seems almost all prolonged in laparoscopic one compared to open one, that makes excessive fluid infusion and hypothermia easily found in laparoscopic group . However, no hypothermia and laryngeal edema were noted in our hospital compare to previous study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 28, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• children who had undergone Kasai portoenterostomy between January 2011 and December 2021

Exclusion Criteria:

• severe congenital heart disease requiring surgical treatment,

• reoperation,

• a diagnosis of non-biliary atresia,

• incomplete medical records.

Related Conditions & MeSH terms

• Biliary Atresia

Intervention

Procedure:
• laparoscopic
laparoscopic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fluid intake_1	intravenous fluid infusion during the operation ( ml)	through study completion, an average of 1 year
Primary	fluid intake_2	transfusion volume during the operation (ml)	through study completion, an average of 1 year
Primary	output_1	urine output	through study completion, an average of 1 year
Primary	output_2	blood loss (ml)	through study completion, an average of 1 year
Secondary	respiratory outcomes_1	extubation time ( duration between extubation and end of the surgery)	through study completion, an average of 1 year
Secondary	respiratory outcomes_2	EtCO2	through study completion, an average of 1 year
Secondary	respiratory outcomes_3	peak airway pressure	through study completion, an average of 1 year
Secondary	surgery duration of the surgery	total surgery time	through study completion, an average of 1 year
Secondary	total days of hospitalization	total hospital days	through study completion, an average of 1 year
Secondary	total days of admission to ICU	total ICU days	through study completion, an average of 1 year
Secondary	surgery-related outcomes_1	postoperative day 1 liver function ( GOT, GPT,bilirubin in the postoperative day 1)	through study completion, an average of 1 year
Secondary	surgery-related outcomes_2	native liver survival time ( duration before liver transplantation)	through study completion, an average of 1 year
Secondary	surgery-related outcomes_3	cholangitis ( cholangitis needes antibiotics treatment)	through study completion, an average of 1 year
Secondary	surgery-related outcomes_4	6-month bilirubin clearance rate ( bilirubin below standard rate at 6-month)	through study completion, an average of 1 year