UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013841 |
|---|---|
| Receipt number | 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 10:32:01 |
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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
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
shirobe@chibatoku.or.jp
Sponsor or person
Institute
Chiba Tokushukai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016098
