NCT04277065

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

February 14, 2020

Last Update Submit

February 18, 2020

Conditions

Laparoscopic Liver ResectionVascular OcclusionTourniquet

Keywords

Laproscopic hepatectomyBulldogVascular occlusion

Outcome Measures

Primary Outcomes (1)

  • Blood loss

    the volume of blood loss

    intraoperative

Secondary Outcomes (15)

  • Liver functional recovery

    up to 7 days after liver resection

  • Postoperative complication(Rates in different grades)

    up to 30 days after liver resection

  • Mortality rates

    up to 30 days after liver resection

  • Hospital duration after operation (days)

    up to 30 days after liver resection

  • Operation time(min)

    intraoperative

  • +10 more secondary outcomes

Study Arms (2)

Bulldog tourniquet in laparoscopic Hepatectomy

EXPERIMENTAL

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.

Procedure: BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection

cotton tourniquet in laparoscopic Hepatectomy

ACTIVE COMPARATOR

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

Procedure: cotton tourniquet

Interventions

BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver ResectionPROCEDURE

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

Bulldog tourniquet in laparoscopic Hepatectomy
cotton tourniquetPROCEDURE

cotton tourniquet

cotton tourniquet in laparoscopic Hepatectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 2nd affiliated hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Related Publications (7)

  • 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.

    PMID: 18035269BACKGROUND

  • 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.

    PMID: 25159645BACKGROUND

  • 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.

    PMID: 26700223BACKGROUND

  • 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.

    PMID: 22183106BACKGROUND

  • 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.

    PMID: 23895579BACKGROUND

  • 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.

    PMID: 28121916BACKGROUND

  • 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.

    PMID: 24622763RESULT

Central Study Contacts

Liang He, Master

CONTACT

13655600231heliang20062007@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the hepatobiliary surgery department

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 20, 2020

Study Start

March 1, 2020

Primary Completion

July 1, 2022

Study Completion

September 1, 2022

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

CN(1)