Outcomes of two-stage liver resection in the treatment of a rare type of primary liver cancer
| ISRCTN | ISRCTN10972467 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10972467 |
- Submission date
- 23/04/2022
- Registration date
- 16/06/2022
- Last edited
- 04/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Different approaches have been introduced for the treatment of patients with liver cancer. However, in some cases, surgical treatment is considered the best and only option to eliminate the disease and guarantee the patients a better therapeutic outcome. Cholangiocarcinoma is a liver cancer originating from biliary structures which can only be treated efficiently by liver surgery. Liver surgery is a major surgery with a wide range of risks, which might result in different complications and even death. Particularly in patients with cholangiocarcinoma, a large volume of the liver is removed during surgery to prevent the recurrence of the disease. This can lead to liver dysfunction and even more dangerous complications. Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a new technique for liver surgery which involves two stages of surgery and is believed to prevent hazardous complications after high-volume liver resection due to its stepwise process that provides the liver enough time for recovery. However, the outcomes of ALPPS in the treatment of patients with cholangiocarcinoma are not well-understood. This study evaluates the impact of ALPPS in the treatment of patients with cholangiocarcinoma.
Who can participate?
Patients with cholangiocarcinoma who underwent ALPPS between 2011 and 2021 at Heidelberg University Hospital
What does the study involve?
The outcomes of patients who have undergone the ALPPS procedure will be evaluated to assess the complications after surgery.
What are the possible benefits and risks of participating?
The results of the study will show the effectiveness of ALPPS in these patients.
Where is the study run from?
Heidelberg University Hospital (Germany)
When is the study starting and how long is it expected to run for?
January 2011 to January 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Ali Ramouz
ali.ramouz@med.uni-heidelberg.de
Contact information
Principal Investigator
Im Neuenheimer Feld 420
Heidelberg
69120
Germany
| Phone | +49 (0)62215632475 |
|---|---|
| arianeb.mehrabi@med.uni-heidelberg.de |
Scientific
Im Neuenheimer Feld 420
Heidelberg
69120
Germany
| Phone | +49 (0)62215632475 |
|---|---|
| ali.ramouz@med.uni-heidelberg.de |
Study information
| Study design | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Outcomes of modified associating liver partition and portal vein ligation for staged hepatectomy in cholangiocarcinoma |
| Study acronym | HD-ALPPS |
| Study objectives | Modified associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) provide better outcomes compared to conventional ALPPS. |
| Ethics approval(s) | Approved 06/12/2018, Independent Ethics Committee of the University of Heidelberg (Alte Glockengießerei 11/1, 69115 Heidelberg, Germany; +49 (0)6221 562646-0; ethikkommission-I@med.uni-heidelberg.de), ref: S-754/2018 |
| Health condition(s) or problem(s) studied | Cholangiocarcinoma |
| Intervention | In 2016, the researchers started using the ALPPS risk score to preoperatively assess patients for the ALPPS procedure. Patients with cholangiocarcinoma relevant hyperbilirubinemia were candidates to undergo preoperative biliary drainage, to resolve the bile stasis and decrease the serum levels of bilirubin. The researchers also modified the standard ALPPS procedure by minimizing the first stage of the surgical procedure. The specific modification during the first stage involved delaying biliary reconstruction and externalization of biliary flow. The externalization of biliary flow was carried out to reduce the risk of bacteremia and decompressing the proximal bile duct. Thus, a pediatric feeding tube was inserted into the proximal bile duct. During the interphase stage, antibiotics were administered to all patients. Biliary reconstructions were performed during the second stage. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Postoperative morbidities classified as grade I to V based on the Clavien–Dindo classification during the hospital stay |
| Secondary outcome measures | 1. Post-hepatectomy liver failure (PHLF) evaluated using the definition provided by the international study group of liver surgery (ISGLS), and classified respectively according to severity grade, during the 90-day postoperative period 2. Post-hepatectomy bile leakage (PHBL) evaluated using the definition provided by the international study group of liver surgery (ISGLS), and classified respectively according to severity grade, during the 90-day postoperative period 3. Post-hepatectomy liver hemorrhage (PHH) evaluated using the definition provided by the international study group of liver surgery (ISGLS), and classified respectively according to severity grade, during the 90-day postoperative period |
| Overall study start date | 01/01/2011 |
| Completion date | 01/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | Patients with cholangiocarcinoma undergoing the ALPPS procedure |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/10/2011 |
| Date of final enrolment | 01/10/2022 |
Locations
Countries of recruitment
- Germany
Study participating centre
Im Neuenheimer Feld 420
Heidelberg
69120
Germany
Sponsor information
Hospital/treatment centre
Im Neuenheimer Feld 420
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 6110 |
|---|---|
| contact@med.uni-heidelberg.de | |
| Website | https://www.klinikum.uni-heidelberg.de/Willkommen-in-der-Klinik.112110.0.html |
"ROR" |
https://ror.org/05fe3fx56 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data of participants, including demographic data, and intraoperative and postoperative outcomes, will be provided anonymously upon the logical request, including requests for multicenter studies and collaborations, without limitation in the availability period. The data will be made available after evaluation of the study protocol and ethical approvals by the principal investigator Prof. Dr. med. Arianeb Mehrabi (arianeb.mehrabi@med.uni-heidelberg.de). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2023 | 31/05/2023 | Yes | No | |
| Results article | 28/11/2023 | 04/07/2024 | Yes | No |
Editorial Notes
04/07/2024: Publication reference added.
31/05/2023: Publication reference added.
16/05/2022: Trial's existence confirmed by the Independent Ethics Committee of the University of Heidelberg.
