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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04100304
Other study ID # liver resection
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date July 30, 2022

Study information

Verified date September 2019
Source Assiut University
Contact Moaz Ahmed, master
Phone 01097179297
Email moathahmad294@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

- Review the outcomes of the current treatments modalities.

- Give an effective treatment .

- Improve the outcome of these patients and decease rate of recurrence and complications.

- An adequate future liver remnant (FLR) reduces the risk of postoperative liver failure after major hepatectomy.

- incurs a risk of postoperative liver dysfunction and infection and there is a lack of objective evidence relating residual liver volume to these complications


Description:

A liver resection is the surgical removal of all or a portion of the liver. It is also referred to as a hepatectomy, full or partial. A complete liver resection is performed in the setting of a transplant a diseased liver is removed from a deceased donor (cadaver). A living donor may also provide a piece of liver tissue which is procured through a partial hepatectomy, The procedure may be performed through a traditional open procedure or using minimally invasive techniques.

When is Liver Resection Performed Most hepatectomies are performed for the treatment of hepatic neoplasms, both benign or malignant. Benign neoplasms include hepatocellular adenoma, hepatic hemangioma and focal nodular hyperplasia.The most common malignant neoplasms (cancers) of the liver are metastases; those arising from colorectal cancer are among the most common, and the most amenable to surgical resection. The most common primary malignant tumour of the liver is the hepatocellular carcinoma. Hepatectomy may also be the procedure of choice to treat intrahepatic gallstones or parasitic cysts of the liver.

Liver surgery is safe when performed by experienced surgeons with appropriate technological and institutional support. As with most major surgical procedures, there is a marked tendency towards optimal results at the hands of surgeons with high caseloads in selected centres (typically cancer academic medical centers and transplantation centers).

Partial hepatectomy is surgery to remove part of the liver. Only people with good liver function who are healthy enough for surgery and who have a single tumor that has not grown into blood vessels can have this operation.

Imaging tests, such as CT or MRI with angiography are done first to see if the cancer can be removed completely. Still, sometimes during surgery the cancer is found to be too large or has spread too far to be removed, and the surgery that has been planned cannot be done.

Can a portion of the remaining normal liver grow back? When a portion of a normal liver is removed, the remaining liver can grow back (regenerate) to the original size within several weeks. A cirrhotic liver, however, cannot grow back. Therefore, before resection is performed for HCC, the non-tumor portion of the liver should be biopsied to determine whether there is associated cirrhosis.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date July 30, 2022
Est. primary completion date March 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients undergoing liver resection for benign or malignant hepatic neoplasm at the time of study(two years)

- Patient consent.

- Age of the patient : Any age

Exclusion Criteria:

- patients has contraindication to do liver resection surgery.

- patients who are unfit for any surgical interventions.

- patients who refuse the operation or refusing to share his data.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
resection
CT volumetry,liver function,biopsy before resection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

Horiuchi T, Haruki K, Shiba H, Sakamoto T, Saito N, Shirai Y, Iwase R, Fujiwara Y, Yanaga K. Assessment of Outcome of Hepatic Resection for Extremely Elderly Patients With a Hepatic Malignancy. Anticancer Res. 2019 Sep;39(9):5143-5148. doi: 10.21873/anticanres.13709. — View Citation

Huiskens J, Bolhuis K, Engelbrecht MR, De Jong KP, Kazemier G, Liem MS, Verhoef C, de Wilt JH, Punt CJ, van Gulik TM; Dutch Colorectal Cancer Group. Outcomes of Resectability Assessment of the Dutch Colorectal Cancer Group Liver Metastases Expert Panel. J Am Coll Surg. 2019 Sep 11. pii: S1072-7515(19)32062-9. doi: 10.1016/j.jamcollsurg.2019.08.1445. [Epub ahead of print] — View Citation

Rotellar F, Martí-Cruchaga P, Zozaya G, Tuero C, Luján J, Benito A, Hidalgo F, Lopez-Olaondo L, Pardo F. Standardized laparoscopic central hepatectomy based on hilar caudal view and root approach of the right hepatic vein. J Hepatobiliary Pancreat Sci. 2019 Sep 13. doi: 10.1002/jhbp.669. [Epub ahead of print] — View Citation

Wang Z, Sun H, Li K, Yao W, Dong K, Ma Y, Zheng S. Prognostic Factor Analysis of Stage 4S Neuroblastoma in Infant Patients: A Single Center Study. J Pediatr Surg. 2019 Aug 30. pii: S0022-3468(19)30571-8. doi: 10.1016/j.jpedsurg.2019.08.031. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation Evaluation of the remaining part of the liver by CTvolumetry for further management as liver transplant preoperative
Secondary energy expenditure Change in total energy expenditure (Kcal) following liver resection [ Time Frame: 30 days ]
Secondary Procedural parameters including intraoperative blood loss intraoperative
Secondary Long-term outcomes 5-year tumor recurrence rate 5 years
Secondary Perioperative liver function including serum levels of alanine aminotransferase (ALT) 30 days preoperative
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