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Laparoscopic Liver ResectionNCT04277065

Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy for Patients

A study testing BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection and cotton tourniquet in people with Laparoscopic Liver Resection and Vascular Occlusion, run by hui hou at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection and cotton tourniquet
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteChina
Study dates
1 Mar 2020to 1 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient who underwent hepatectomy for benign or malignant neoplasm of the liver, and is suitable for laparoscopic liver resection
  • Child-Pugh A without portal hypertension
  • No portosystemic shunt
  • No previous abdominal operation history
  • American society of anesthesiology class(ASA): I or II
  • Age 18 to 80

Who cannot join

  • Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
  • Emergence hepatectomy
  • Previous hepatectomy
  • Combined operation for extrahepatic disease
  • Vulnerable population (mental retardation, pregnancy)

Trial locations and contacts

1 site in 1 country.

Liang He, Master contact

13655600231 ext. +86

heliang20062007@163.com

China1 site

  • The 2nd affiliated hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Liang He, Master, 13655600231 ext. +86, heliang20062007@163.com

Other trials in China

About this study

Official title: Short Outcomes Between Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy

LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and donor hepatectomies by skilled surgeons. However, postoperative mortality, mobility and recovery of liver function are associated with major blood loss which is always the main cause of conversion to laparotomy and remains a challenge for surgeons. Pringle first described the method to arrest the hepatic hemorrhage by compression of the porta hepatis and this procedure was widely spread as well as in laparoscopic feild currently. Here, we described a new modified of Pringle maneuver using Bulldog to block vascular during LLR, and compared its effects with traditional pringle maneuver.

Read the detailed description

With the innovations of laparoscopic technique and specialized equipment , laparoscopic liver resection became the dominating resection surgery approach. December of 2014, laparoscopic hepatectomy was carried out in our department, extracorporeal Pringle maneuver has been applied in most laparoscopic liver resections which need to block the hepatic inflow, cotton tape was the frequently used tourniquet. We used to blocked the hepatic inflow by extracorporeal Pringle maneuver method with cotton tape for its validity , softness and no visible damages for vessel, but it was always difficult for clamping in a two-dimensional view to encircle the hepatoduodenal ligament , and it delayed operation time for freshmen. Bulldog has been widely used in urinary surgery for vascular occlusion, but bulldog in hepatic surgery has rarely been mentioned, this is the first report to formally demonstrate the clinical application in hepatic surgery. However, it is not clear that whether the bulldog for vascular occlusion is useful and easy to implement in laparoscopic hepatectomy. In this study, we will compare the cotton and the bulldog for vascular occlusion during laparoscopic hepatectomy

Being tested
BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection, cotton tourniquet
Keywords
Laproscopic hepatectomy, Bulldog, Vascular occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver ResectionProcedure or surgery

    Bulldog is an effectively performed approach for vascular occlusion during laparoscopic hepatectomy than traditional Pringle manuever.

  • cotton tourniquetProcedure or surgery

    cotton tourniquet

Study groups in NCT04277065
Study groupRoleWhat they receive
Bulldog tourniquet in laparoscopic HepatectomyExperimentalThe bulldog tourniquet , a reusable vessel occlusion instrument forblocking the liver inflow-blood in laparoscopic liver resection, was uniformly employed in all patients randomized to Bulldog laparoscopic hepatectom group in the present study.
Receives: Procedure: BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection
cotton tourniquet in laparoscopic HepatectomyActive comparatorThe cotton tourniquet ,a reusable vessel occlusion instrument for blocking the liver inflow-blood in laparoscopic liver resection
Receives: Procedure: cotton tourniquet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood loss

    the volume of blood loss

    Measured: intraoperative

Secondary outcomes (15)

  1. Liver functional recovery

    AST(glutamic oxalacetic transaminase, u/l)

    Measured: up to 7 days after liver resection

  2. Postoperative complication(Rates in different grades)

    According to The Clavien-Dindo Classification,https://www.assessurgery.com/clavien-dindo-classification/

    Measured: up to 30 days after liver resection

  3. Mortality rates

    the rate of postoperative death

    Measured: up to 30 days after liver resection

  4. Hospital duration after operation (days)

    the length of hospital stay

    Measured: up to 30 days after liver resection

  5. Operation time(min)

    the during of operation

    Measured: intraoperative

  6. Blood transfusion (times and units)

    intraoperative blood transfusion

    Measured: intraoperative

  7. the clamping and declamping time(s)

    the clamping and declamping time of using bulldog or cotton

    Measured: intraoperative

  8. Duration of abdominal drain (days)

    Duration of abdominal drain

    Measured: up to 14 days after liver resection

  9. Duration to first flatus (days)

    Duration to first flatus

    Measured: up to 14 days after liver resection

  10. Comfort questionnaire measures (GCQ) measures by Kolcaba

    GCQ measures by Kolcaba, download from http://www.thecomfortline.com/resources/cq.html

    Measured: up to 30 days after liver resection

  11. Intensive care unit stay(days)

    Intensive care unit stay in days

    Measured: up to 7 days after liver resection

  12. Liver functional recovery

    ALT(glutamic-pyruvic transaminase enzyme，u/l)

    Measured: up to 7 days after liver resection

  13. Liver functional recovery

    TB(total bilirubin，μmol/L)

    Measured: up to 7 days after liver resection

  14. Liver functional recovery

    ALB(albumin，g/L)

    Measured: up to 7 days after liver resection

  15. Liver functional recovery

    TP(total protein，g/L)

    Measured: up to 7 days after liver resection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start1 Mar 2020 (estimated)
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion1 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04277065
Sponsor's protocol ID
1234
Status last verified
Feb 2020
First submitted
14 Feb 2020
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Maehara S, Adachi E, Shimada M, Taketomi A, Shirabe K, Tanaka S, Maeda T, Ikeda K, Higashi H, Maehara Y. Clinical usefulness of biliary scope for Pringle's maneuver in laparoscopic hepatectomy. J Am Coll Surg. 2007 Dec;205(6):816-8. doi: 10.1016/j.jamcollsurg.2007.06.297. Epub 2007 Sep 18. No abstract available.

    PubMed 18035269

  • Dua MM, Worhunsky DJ, Hwa K, Poultsides GA, Norton JA, Visser BC. Extracorporeal Pringle for laparoscopic liver resection. Surg Endosc. 2015 Jun;29(6):1348-55. doi: 10.1007/s00464-014-3801-6. Epub 2014 Aug 27.

    PubMed 25159645

  • Ciria R, Cherqui D, Geller DA, Briceno J, Wakabayashi G. Comparative Short-term Benefits of Laparoscopic Liver Resection: 9000 Cases and Climbing. Ann Surg. 2016 Apr;263(4):761-77. doi: 10.1097/SLA.0000000000001413.

    PubMed 26700223

  • Rotellar F, Pardo F, Bueno A, Marti-Cruchaga P, Zozaya G. Extracorporeal tourniquet method for intermittent hepatic pedicle clamping during laparoscopic liver surgery: an easy, cheap, and effective technique. Langenbecks Arch Surg. 2012 Mar;397(3):481-5. doi: 10.1007/s00423-011-0887-3. Epub 2011 Dec 20.

    PubMed 22183106

  • Le B, Matulewicz RS, Eaton S, Perry K, Nadler RB. Comparative analysis of vascular bulldog clamps used in robot-assisted partial nephrectomy. J Endourol. 2013 Nov;27(11):1349-53. doi: 10.1089/end.2013.0367. Epub 2013 Oct 18.

    PubMed 23895579

  • Kim WJ, Kim KH, Shin MH, Yoon YI, Lee SG. Totally laparoscopic anatomical liver resection for centrally located tumors: A single center experience. Medicine (Baltimore). 2017 Jan;96(4):e5560. doi: 10.1097/MD.0000000000005560.

    PubMed 28121916

  • Ikeda T, Toshima T, Harimoto N, Yamashita Y, Ikegami T, Yoshizumi T, Soejima Y, Shirabe K, Maehara Y. Laparoscopic liver resection in the semiprone position for tumors in the anterosuperior and posterior segments, using a novel dual-handling technique and bipolar irrigation system. Surg Endosc. 2014 Aug;28(8):2484-92. doi: 10.1007/s00464-014-3469-y. Epub 2014 Mar 13.

    PubMed 24622763

Questions about this trial

What is this clinical trial studying?

A study testing BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection and cotton tourniquet in people with Laparoscopic Liver Resection and Vascular Occlusion, run by hui hou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liang He, Master (13655600231 ext. +86, heliang20062007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood loss (time frame: intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04277065, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.

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