Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

Not Applicable

• Conditions: Cholangiocarcinoma, Perihilar; Surgery
• Interventions: Procedure: Three dimensional laparoscopic resection for pCCA; Procedure: Open resection for pCCA

• Registration Number: NCT03383796
• Lead Sponsor: Tongji Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2017-12-26
• Study Start: 2018-03-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-03-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D approach	Three dimensional laparoscopic resection for pCCA	Three dimensional laparoscopic resection for pCCA
open approach	Open resection for pCCA	Open resection for pCCA

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China