NCT03270917

Brief Summary

The international and multicentre ORANGE SEGMENTS - Trial is a prospective, double blinded, randomized controlled study comparing patients undergoing parenchymal preserving resection of postero-superior liver segments (involving one or two of segments 4a, 7, 8). All patients will be participating in an enhanced recovery programme. Primary outcome is time to functional recovery. Secondary study parameters include hospital length of stay, intraoperative blood loss, operation time, liver specific morbidity, readmission percentage, resection margin, quality of life, body image and cosmesis , reasons for delay of discharge after functional recovery, long term incidence of incisional hernias, hospital and societal costs during one year, time to adjuvant chemotherapy initiation, overall five-year survival.

Trial Health

82
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
6 countries

16 active sites

Status
active not recruiting

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

Study Progress95%
Nov 2017Nov 2026

First Submitted

Initial submission to the registry

August 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

May 19, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

August 28, 2017

Last Update Submit

May 16, 2025

Conditions

Liver Surgery

Keywords

Parenchymal preservingPostero-superiorLaparoscopyHepatectomy

Outcome Measures

Primary Outcomes (1)

  • Time to functional recovery

    Time until a patient is functionally recovered

    expected average of 4-10 days

Secondary Outcomes (13)

  • Hospital length of stay

    30 days

  • Intraoperative blood loss

    during procedure

  • Operating time

    surgical time from incision until closure

  • (Liver specific) morbidity

    1 year

  • Readmission percentage

    1 year

  • +8 more secondary outcomes

Study Arms (2)

Open

OTHER

Open liver surgery

Procedure: Parenchymal preserving postero-superior liver segment resection

Laparoscopy

OTHER

Laparoscopic liver surgery

Procedure: Parenchymal preserving postero-superior liver segment resection

Interventions

Parenchymal preserving postero-superior liver segment resectionPROCEDURE

Parenchymal preserving liver segment resection of one or two of the postero-superior liver segments (4A, 7 or 8).

LaparoscopyOpen

Eligibility Criteria

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

You may qualify if:

  • Patients requiring a parenchymal sparing liver resection (including wedge resections and full segmentectomies) involving one or two of segments 4a/7/8 for accepted indications . A segment 6/7 resection would also be eligible.
  • Able to understand the nature of the study and what will be required of them.
  • Men and non-pregnant, non-lactating women, aged 18 years and older.
  • BMI between and including 18-35 kg/m2
  • Patients with ASA physical status I-II-III.

You may not qualify if:

  • Inability to give (written) informed consent.
  • Patients requiring other liver surgery than a parenchymal sparing resection involving one or two of segments 4a, 7, 8.
  • Patients requiring parenchymal sparing liver resection involving segment 1. This is due to the high level of technical difficulty.
  • Patients with hepatic lesion(s), that are located with insufficient margin from vascular or biliary structures to be operated laparoscopically.
  • Patients with ASA physical status IV-V.
  • Repeat hepatectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

General Hospital Groeninge

Kortrijk, Belgium

Location

Poliambulanza Hospital

Brescia, Italy

Location

San Raffaele Hospital

Milan, Italy

Location

San Camillo-Forlanini Hospital

Rome, Italy

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Maastricht University Medical Center+

Maastricht, Netherlands

Location

University Hospital Oslo

Oslo, Norway

Location

Moscow Clinical Scientific Center

Moscow, Russia

Location

Aintree University Hospital

Aintree, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Oxford University Hospitals

Oxford, United Kingdom

Location

Derriford Hospital

Plymouth, United Kingdom

Location

University Hospital Southampton

Southampton, United Kingdom

Location

Related Publications (6)

  • Coles SR, Besselink MG, Serin KR, Alsaati H, Di Gioia P, Samim M, Pearce NW, Abu Hilal M. Total laparoscopic management of lesions involving liver segment 7. Surg Endosc. 2015 Nov;29(11):3190-5. doi: 10.1007/s00464-014-4052-2. Epub 2015 Jan 13.

    PMID: 25582963BACKGROUND

  • Cipriani F, Shelat VG, Rawashdeh M, Francone E, Aldrighetti L, Takhar A, Armstrong T, Pearce NW, Abu Hilal M. Laparoscopic Parenchymal-Sparing Resections for Nonperipheral Liver Lesions, the Diamond Technique: Technical Aspects, Clinical Outcomes, and Oncologic Efficiency. J Am Coll Surg. 2015 Aug;221(2):265-72. doi: 10.1016/j.jamcollsurg.2015.03.029. Epub 2015 Mar 27.

    PMID: 25899733BACKGROUND

  • Scuderi V, Barkhatov L, Montalti R, Ratti F, Cipriani F, Pardo F, Tranchart H, Dagher I, Rotellar F, Abu Hilal M, Edwin B, Vivarelli M, Aldrighetti L, Troisi RI. Outcome after laparoscopic and open resections of posterosuperior segments of the liver. Br J Surg. 2017 May;104(6):751-759. doi: 10.1002/bjs.10489. Epub 2017 Feb 13.

    PMID: 28194774BACKGROUND

  • Zheng B, Zhao R, Li X, Li B. Comparison of laparoscopic liver resection for lesions located in anterolateral and posterosuperior segments: a meta-analysis. Surg Endosc. 2017 Nov;31(11):4641-4648. doi: 10.1007/s00464-017-5527-8. Epub 2017 Apr 7.

    PMID: 28389796BACKGROUND

  • Sijberden JP, Kuemmerli C, Ratti F, D'Hondt M, Sutcliffe RP, Troisi RI, Efanov M, Fichtinger RS, Diaz-Nieto R, Ettorre GM, Sheen AJ, Menon KV, Besselink MG, Soonawalla Z, Aroori S, Marino R, De Meyere C, Marudanayagam R, Zimmitti G, Olij B, Eminton Z, Brandts L, Ferrari C, M van Dam R, Aldrighetti LA, Pugh S, Primrose JN, Abu Hilal M. Laparoscopic versus open parenchymal preserving liver resections in the posterosuperior segments (ORANGE Segments): a multicentre, single-blind, randomised controlled trial. Lancet Reg Health Eur. 2025 Feb 20;51:101228. doi: 10.1016/j.lanepe.2025.101228. eCollection 2025 Apr.

    PMID: 40060302DERIVED

  • Kuemmerli C, Fichtinger RS, Moekotte A, Aldrighetti LA, Aroori S, Besselink MGH, D'Hondt M, Diaz-Nieto R, Edwin B, Efanov M, Ettorre GM, Menon KV, Sheen AJ, Soonawalla Z, Sutcliffe R, Troisi RI, White SA, Brandts L, van Breukelen GJP, Sijberden J, Pugh SA, Eminton Z, Primrose JN, van Dam R, Hilal MA; ORANGE trials collaborative. Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial. Trials. 2022 Mar 9;23(1):206. doi: 10.1186/s13063-022-06112-3.

    PMID: 35264216DERIVED

Study Officials

  • Mohammed Abu Hilal, Prof.

    University Hospital Southampton NHS Foundation Trust

    STUDY CHAIR

  • John Primrose, Prof.

    University Hospital Southampton NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The patient, ward physician and research investigator are blinded to the treatment intervention. A large abdominal dressing will be used to cover the incision(s) until postoperative day 4. Obviously, the surgeon and anaesthesiology team can not be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomised to either the open or the laparoscopic treatment arm.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2017

First Posted

September 1, 2017

Study Start

November 1, 2017

Primary Completion

November 1, 2021

Study Completion (Estimated)

November 1, 2026

Last Updated

May 19, 2025

Record last verified: 2025-05

Locations

BE(1)RU(1)NL(2)GB(8)NO(1)IT(3)