## Protocol Section
### Identification Module
**NCT ID:** NCT02727179

**Acronym:** LapOpHuva

**Brief Title:** Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases

**Official Title:** Prospective and Randomized Study Comparing Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases

#### Organization Study ID Info
**ID:** HUVA-0515
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitario Virgen de la Arrixaca
### Status Module
#### Completion Date
**Date:** 2017-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-12-20

**Type:** ACTUAL

**Last Update Submit Date:** 2017-12-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-03

**Type:** ACTUAL

#### Start Date
**Date:** 2005-02

**Status Verified Date:** 2017-12

#### Study First Post Date
**Date:** 2016-04-04
**Type:** ESTIMATED
**Study First Submit Date:** 2016-03-14
**Study First Submit QC Date:** 2016-03-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital Universitario Virgen de la Arrixaca

#### Responsible Party

**Investigator Affiliation:** Hospital Universitario Virgen de la Arrixaca

**Investigator Full Name:** Ricardo Robles Campos

**Investigator Title:** MD, PHD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study evaluates the feasibility of laparoscopic surgery in patients diagnosed with colorectal liver metastases. Half of participants will be operated on by laparoscopic approach and the results obtained will be compared with the results from the other half of patients operated on by open approach.

**Detailed Description:** The safety and efficacy of liver surgery in the treatment of colorectal liver metastases are well established for the open approach. It allows good results in terms of complications, disease free survival and overall survival, and for these reasons it has become the gold standard technique in the treatment of colorectal liver metastases.

On the contrary, the role of laparoscopic liver resection in this context is not so clear nowadays. Generally, laparoscopic surgery offers some advantages such as less pain, shorter hospital stay and better aesthetic results. But the use of laparoscopic approach in liver surgery is still discussing: two international consensus conferences have been held and no strong conclusions have been made. Furthermore for colorectal liver metastases no randomized trials, comparing both techniques, have been published until now.

To assess the feasibility of laparoscopic liver resection for colorectal metastases, the investigators propose this trial in which the patients suitable for laparoscopic approach are randomized to open or laparoscopic group

### Conditions Module

**Conditions:**

- Colorectal Liver Metastasis

- Laparoscopic Liver Resection

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Liver resection performed by laparoscopic approach

**Intervention Names:**

- Procedure: Liver resection

**Label:** Laparoscopic group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Liver resection performed by open approach

**Intervention Names:**

- Procedure: Liver resection

**Label:** Open group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Laparoscopic group

- Open group

**Description:** The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics

**Name:** Liver resection

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Overall survival

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** Duration of the surgical intervention

**Measure:** Surgical operative time

**Time Frame:** Intraoperative

**Description:** Blood loss in milliliter

**Measure:** Blood losses

**Time Frame:** Intraoperative

**Description:** Number of blood transfusions required during surgical operation

**Measure:** Transfusion

**Time Frame:** Intraoperative

**Description:** Days between surgical operation and hospital discharge

**Measure:** Hospital stay

**Time Frame:** Up to 3 months

**Description:** Days between surgical operation and the beginning of adjuvant chemotherapy

**Measure:** Time between surgery and adjuvant chemotherapy

**Time Frame:** Up to 3 months

**Measure:** Mortality

**Time Frame:** 90 days

**Measure:** Morbidity

**Time Frame:** 90 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with colorectal liver metastases;
* Patients suitable for surgical treatment;
* Patients eligible for laparoscopy approach.

Exclusion Criteria:

* Patients with high tumour load: multiples and bilobar colorectal metastases;
* Patients with big liver metastases or close to major vessels;
* Patients with oncological contraindications for surgery;
* Cirrhotic liver
* Needing for two stage liver resection;
* Medical or psychiatric condition of the patient that compromises the informed consent authorization;
* Refusal to participate in the study

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Murcia

**Country:** Spain

**Facility:** Hospital Universitario "Virgen de la Arrixaca"

**Zip:** 30120

#### Overall Officials

**Official 1:**

**Affiliation:** Hospital Universitario Virgen de la Arrixaca

**Name:** Ricardo Robles Campos, MD; PHD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Robles-Campos R, Lopez-Lopez V, Brusadin R, Lopez-Conesa A, Gil-Vazquez PJ, Navarro-Barrios A, Parrilla P. Open versus minimally invasive liver surgery for colorectal liver metastases (LapOpHuva): a prospective randomized controlled trial. Surg Endosc. 2019 Dec;33(12):3926-3936. doi: 10.1007/s00464-019-06679-0. Epub 2019 Jan 30.

**PMID:** 30701365

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000009369

- Term: Neoplasms

- ID: D000010335

- Term: Pathologic Processes

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000008107

- Term: Liver Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Metastases

- ID: M11113

- Name: Liver Neoplasms

- Relevance: HIGH

- As Found: Liver Metastases

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009362

- Term: Neoplasm Metastasis

- ID: D000008113

- Term: Liver Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
