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Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

China30 participantsStarted 2018-03-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically proven pCCA.
✓. Highly presumed perihlar bile duct malignancy with difficulties to obtain histological evidence.
✓. Preoperative staging work up performed by upper abdomen enhanced CT scan.
✓. The subject understands the nature of this trial and willing to comply.
✓. Ability to provide written informed consent.
✓. Patients treated with curative intent in accordance to international guidelines

Exclusion criteria

✕. Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
✕. Subjects undergoing any part for hepatectomy.
✕. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score \>4.
✕

What they're measuring

Mortality

Timeframe: 24 months

Length of Stay

Timeframe: 24 months

R0 Resection Rate

Timeframe: 24 months

Bile leakage

Timeframe: 24 months

TNM Staging

Timeframe: 24 months

Complication rate

Timeframe: 24 months

Trial details

NCT IDNCT03383796

SponsorTongji Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-01

View on ClinicalTrials.gov More Cholangiocarcinoma, Perihilar trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically proven pCCA.
✓. Highly presumed perihlar bile duct malignancy with difficulties to obtain histological evidence.
✓. Preoperative staging work up performed by upper abdomen enhanced CT scan.
✓. The subject understands the nature of this trial and willing to comply.
✓. Ability to provide written informed consent.
✓. Patients treated with curative intent in accordance to international guidelines

Exclusion criteria

✕. Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
✕. Subjects undergoing any part for hepatectomy.
✕. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score \>4.
✕