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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013841
Receipt No. R000016098
Scientific Title Laparoscopic radical cholecystectomy with lymph nodes dissection for gallbladder carcinoma
Date of disclosure of the study information 2015/12/31
Last modified on 2015/11/02

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Basic information
Public title Laparoscopic radical cholecystectomy with lymph nodes dissection for gallbladder carcinoma
Acronym Laparoscopic radical cholecystectomy with lymph nodes dissection for gallbladder carcinoma
Scientific Title Laparoscopic radical cholecystectomy with lymph nodes dissection for gallbladder carcinoma
Scientific Title:Acronym Laparoscopic radical cholecystectomy with lymph nodes dissection for gallbladder carcinoma
Region
Japan

Condition
Condition T1b/T2 gallbladder carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and noninferiority, compared to traditional open surgery, of laparoscopic radical cholecystectomy to treat with T1b/T2 gallbladder carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Operative time, blood loss, post-operative complication, the period of hospital stay, tumor recurrence, and survival of the patients who underwent laparoscopic radical cholecystectomy.
Key secondary outcomes Necessity of resection of the common bile duct and liver bed, the number of the lymph nodes dissected, and adjuvant therapy.

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Between November 2001 and June 2013, laparoscopic radical cholecystectomy was conducted to the patients who were preoperatively diagnosed with T1b/T2 gallbladder carcinoma, or the patients diagnosed with ocult T1b/T2 gallbladder carcinoma by postoperative pathological examination after laparoscopic cholecystectomy. End points are tumor recurrence and the survival period.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who meet all the following requirements.
1. From June 2001 until June 2013, patients who were diagnosed with T1b/T2 gallbladder carcinoma.
2. The patients who agreed with laparoscopic radical resection.
3. The patients who underwent laparoscopic radical cholecystectomy with lymph nodes dissection.
Key exclusion criteria The patient who did not agree with laparoscopic surgery.
Target sample size 11

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Shirobe
Organization Chiba Tokushukai Hospital
Division name Department of Surgery
Zip code
Address 1-27-1 Narashinodai, Funabashi, Chiba 274-0063
TEL 047-466-7111
Email shirobe@chibatoku.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Shirobe
Organization Chiba Tokushukai Hospital
Division name Department of Surgery
Zip code
Address 1-27-1 Narashinodai, Funabashi, Chiba 274-0063
TEL 047-466-7111
Homepage URL
Email shirobe@chibatoku.or.jp

Sponsor
Institute Chiba Tokushukai Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 多摩丘陵病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Abstract
Background Laparoscopic surgery has been widely
employed in the field of digestive surgery, since the minimally
invasive procedure provides a significant benefit to patients.
However, laparoscopic curative surgery for gallbladder cancer has been rarely described. The aim of this study was to
evaluate the effectiveness and validity of laparoscopic radical
cholecystectomy with lymph node dissection (Lap-RC) to
treat with T1b/T2 gallbladder carcinoma.
Methods A total of 11 patients underwent Lap-RC for
gallbladder carcinoma from November 2001 until June
2013. While 4 patients were preoperatively diagnosed with
T1b/T2 gallbladder carcinoma, 7 patients were diagnosed
with incidental T1b/T2 gallbladder carcinoma by postoperative pathological examination after laparoscopic cholecystectomy. Common bile duct resection and biliary tract
reconstruction were performed in 2 cases. End points in
this clinical study were tumor recurrence and survival of
patients.
Results Mean operative time was 196 min, and average
hospital stay after surgery was 6.4 days, excluding 2 cases
with biliary tract reconstruction. One patient died of
recurrence of cancer 89 months after surgery, and another
patient died of other reason with local recurrence
39 months after the operation. The other 9 patients were all
alive without recurrence at this writing. The 5-year survival
rate was 100 % for T1b patients and 83.3 % for T2. These
results indicate that almost equivalent outcomes compared
with open surgery in terms of curability were achieved.
Conclusions We conclude that pure laparoscopic radical
cholecystectomy with lymph node dissection is safe and
beneficial for the patients with T1b/T2 gallbladder carcinoma.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2001 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2001 Year 11 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Article

Surgical Endoscopy

August 2015, Volume 29, Issue 8, pp 2244-2250

First online: 11 October 2014

Management information
Registered date
2014 Year 04 Month 29 Day
Last modified on
2015 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016098

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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