Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy for Patients

NCT ID: NCT04277065

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laparoscopic Liver Resection Vascular Occlusion Tourniquet

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bulldog tourniquet in laparoscopic Hepatectomy

The 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.

Group Type EXPERIMENTAL

BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection

Intervention Type PROCEDURE

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

cotton tourniquet in laparoscopic Hepatectomy

The cotton tourniquet ,a reusable vessel occlusion instrument for blocking the liver inflow-blood in laparoscopic liver resection

Group Type ACTIVE_COMPARATOR

cotton tourniquet

Intervention Type PROCEDURE

cotton tourniquet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection

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

Intervention Type PROCEDURE

cotton tourniquet

cotton tourniquet

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

hui hou

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

hui hou

Director of the hepatobiliary surgery department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The 2nd affiliated hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Liang He, Master

Role: CONTACT

13655600231 ext. +86

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Liang He, Master

Role: primary

13655600231 ext. +86

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18035269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25159645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26700223 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22183106 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23895579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28121916 (View on PubMed)

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.

Reference Type RESULT
PMID: 24622763 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1234

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.