Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

Tongji Hospital

Status: Unknown

Conditions: Surgery; Cholangiocarcinoma, Perihilar

Treatments: Procedure: Three dimensional laparoscopic resection for pCCA; Procedure: Open resection for pCCA

Study type: Interventional

Funder types: Other

Identifiers

NCT03383796

TJDBPS02

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

3D approach

Experimental group

Description:

Three dimensional laparoscopic resection for pCCA

Treatment:

Procedure: Three dimensional laparoscopic resection for pCCA

open approach

Experimental group

Description:

Open resection for pCCA

Treatment:

Procedure: Open resection for pCCA