Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

Tongji Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cholangiocarcinoma, Perihilar Surgery

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mortality

Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.

Time frame: 24 months

Length of Stay

Length of stay was defined as the postoperative time interval in days.

Time frame: 24 months

R0 Resection Rate

Negative margin rate.

Time frame: 24 months

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.

Time frame: 24 months

TNM Staging

According to AJCC guideline, each patients TNM staging were recorded.

Time frame: 24 months

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.

Time frame: 24 months

Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes