Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

• Sponsor: Tongji Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03383796
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site: 15
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholangiocarcinoma, Perihilar; Surgery	Procedure: Three dimensional laparoscopic resection for pCCA; Procedure: Open resection for pCCA	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Clinical Trial Comparing Three Dimension Laparoscopic and Open Surgery for Perihiliar Cholangiocarcinoma
• Actual Study Start Date: Mar 1, 2018
• Anticipated Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3D approach Three dimensional laparoscopic resection for pCCA	Procedure: Three dimensional laparoscopic resection for pCCA; Three dimensional laparoscopic resection for pCCA
Experimental: open approach Open resection for pCCA	Procedure: Open resection for pCCA; Open resection for pCCA

Outcome Measures

Primary Outcome Measures

1. Mortality [24 months]

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

2. Length of Stay [24 months]

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

3. R0 Resection Rate [24 months]

   Negative margin rate.

4. 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.

5. TNM Staging [24 months]

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

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital	Wuhan	Hubei	China	430000
2	Tongji Hospital	Wuhan	Hubei	China

Sponsors and Collaborators

• Tongji Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Renyi Qin, Clinical professor, Tongji Hospital
• ClinicalTrials.gov Identifier: NCT03383796
• Other Study ID Numbers: TJDBPS02
• First Posted: Dec 26, 2017
• Last Update Posted: Oct 8, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Renyi Qin, Clinical professor, Tongji Hospital: Cholangiocarcinoma perihilar; three dimension laparoscopic
• Additional relevant MeSH terms: Cholangiocarcinoma; Klatskin Tumor

Study Results

No Results Posted as of Oct 8, 2020