Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

Surgery Clinical Trial

Official title:

Randomized Clinical Trial Comparing Three Dimension Laparoscopic and Open Surgery for Perihiliar Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03383796
• Other study ID #: TJDBPS02
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: October 2020
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cholangiocarcinoma (CCA) is the most common biliary tract malignancy and the second most common primary hepatic malignancy. The prognosis of CCA is dismal. Surgery is the only potentially curative treatment, but the majority of patients present with advanced stage disease, and recurrence after resection is common. It is classified into intrahepatic (iCCA), perihilar (pCCA), and distal (dCCA) subtypes. Among all, pCCA is the most common subtype.

This is a prospective, randomized, controlled multicenter trial with two treatment arms, three dimension laparoscopic approach versus open approach. The trial hypothesis is that three dimension laparoscopic surgery has advantages in postoperative recoveries and be equivalent in operation time, oncological results and long-term follow-up compared with open counterpart. The duration of the entire trial is two years including prearrangement, follow-up and analyses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histologically proven pCCA.

2. Highly presumed perihlar bile duct malignancy with difficulties to obtain histological evidence.

3. Preoperative staging work up performed by upper abdomen enhanced CT scan.

4. The subject understands the nature of this trial and willing to comply.

5. Ability to provide written informed consent.

6. Patients treated with curative intent in accordance to international guidelines

Exclusion Criteria:

1. Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.

2. Subjects undergoing any part for hepatectomy.

3. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4.

4. Synchronous malignancy in other organs.

5. Palliative surgery

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Cholangiocarcinoma, Perihilar
• Klatskin Tumor
• Surgery

Intervention

Procedure:
• Three dimensional laparoscopic resection for pCCA
Three dimensional laparoscopic resection for pCCA
• Open resection for pCCA
Open resection for pCCA

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.	24 months
Primary	Length of Stay	Length of stay was defined as the postoperative time interval in days.	24 months
Primary	R0 Resection Rate	Negative margin rate.	24 months
Primary	Bile leakage	The drain bilirubin was monitored after surgery, any elevation for the bilirubin level or the diagnostic puncture proved bile fluid in abdominal cavity.	24 months
Primary	TNM Staging	According to AJCC guideline, each patients TNM staging were recorded.	24 months
Primary	Complication rate	Complication Rate Measure Description Any complication mentioned in the protocol should be carefully record and analyzed, including postoperative hemorrhage, postoperative pancreatic fistula, etc.	24 months