A Prospective Cohort Study: Laparoscopic Versus Open Surgery for Lesions Originating in the Paracaval Portion of the Caudate Lobe
| Registry | NCT04499261 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: single, treatment |
| Enrollment | 110 (Estimated) |
| Sponsor | Southwest Hospital, China (Other) |
| Conditions | Paracaval Portion |
| Interventions | laparoscopic surgery, Open surgery (Procedure) |
| Dates | start 2019-09-25, primary completion 2021-09-25 (estimated), completion 2022-09-25 (estimated), first posted 2020-08-05, last updated 2020-08-05 |
| Locations | 1 site in China |
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All trials for Paracaval Portion All trials of laparoscopic surgery All trials of Open surgery
This study aimed to evaluate the safety, feasibility and efficacy of laparoscopic for resecting paracaval-originating lesions by contrast of open procedures.
The paracaval portion of the caudate lobe is located in the core of the liver. Lesions originating in the paracaval portion often cling to or even invade major hepatic vascular structures. Open surgery is the traditional surgical method for resection of paracaval-originating lesions. With the development of laparoscopic surgery, paracaval-originating lesions are no longer an absolute contraindication for laparoscopic procedures. The high-definition magnified view and ability to change perspectives with the laparoscope are conducive to subtle manipulation, and compression of the carbon dioxide pneumoperitoneum can reduce venous bleeding. Nevertheless, laparoscopic anterior hepatic transection for paracaval-originating lesion resection is still a challenging procedure, and only a few cases have been reported. This study aimed to evaluate the safety, feasibility and efficacy of laparoscopic for resecting paracaval-originating lesions by contrast of open procedures.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| laparoscopic surgery | Experimental | Procedure: laparoscopic surgery | The laparoscopic view is caudal to cephalic, which is consistent with the direction of hepatic transection. In addition, the high-definition magnified view and ability to change perspectives with the laparoscope are conducive to subtle manipulation, and compression of the carbon dioxide pneumoperitoneum can reduce venous bleeding. Therefore, laparoscopic surgery may have certain advantages in the treatment of paracaval-originating lesions. |
| Open surgery | Active comparator | Procedure: Open surgery | Open surgery is the traditional surgical method for resection of paracaval-originating lesions. |
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria: 1. Age: Between 18 to 70 years, both male and female 2. The general condition of the patient can tolerate anesthesia and surgery 3. Paracaval-originating lesion diagnosis is clear preoperative 4. No rupture of the tumor, no bloody ascites, no invasion of the surrounding tissues and distant metastasis 5. Liver function ≥ Child-pugh level B, indocyanine green retention rate at 15 min ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%. 6. Upper abdominal surgery, radiofrequency ablation, Transhepatic Arterial Chemotherapy And Embolization treatment, radiotherapy and chemotherapy have not been implemented 7. Volunteer to participate in the study and sign informed consent Exclusion Criteria: 1\. Age:Younger than 18 or more than 70 years old 2. Pregnant and lactating women 3. Severe cirrhosis, portal hypertension, or active hepatitis are present 4. Severe upper abdominal adhesions 5. The lesion originated in other parts of the liver other than the paracaval portion 6. Patients with poor general condition and could not tolerate surgery or anesthesia \-
| Facility | City | Country | Status |
|---|---|---|---|
| Southwest Hospital | Chongqing, Chongqing Municipality | China | Recruiting |