Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy

Surgery Clinical Trial

Official title:

Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy(TJDBPS01) a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03138213
• Other study ID #: TJDBPS01
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: October 2020
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Minimally invasive surgery has been progressively being developed for pancreatic surgery, first with the advent of hybrid-laparoscopy and recently with total laparoscopic surgery. Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated. Studies comparing these two surgical techniques are emerging, and large randomized controlled trials (RCTs) are lacking but are clearly required.

Methods and analysis TJDBPS01 is a multicentre, prospective, randomized controlled, parallel-group, superiority trial in fourteen centres with pancreatic surgery experts who have performed ≥104 TLPDs and OPDs. A total of 656 patients who will undergo PD are randomly allocated to the TLPD group or OPD group in a 1:1 ratio. The trial hypothesis is that TLPD has superior or equivalent safety and advantages in postoperative recovery compared with OPD. The primary outcome is the postoperative length of stay (LOS).

Ethics and dissemination The Instituitional Review Board Approval of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has approved this trial and will be routinely monitoring the trial at frequent intervals, as will an independent third-party organization. Any results from this trial (publications, conference presentations) will be published in peer-reviewed journals and conference proceedings.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 656
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Histologically proven periampullary cancer, including pancreatic cancer, bile duct cancer, duodenal cancer, et al.

2. Highly presumed malignancy with difficulties to obtain histological evidence.

3. Preoperative staging work up performed by upper abdomen enhanced CT scan.

4. The subject understands the nature of this trial and willing to comply.

5. Ability to provide written informed consent.

6. Patients treated with curative intent in accordance to international guidelines

Exclusion Criteria:

1. Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.

2. Subjects undergoing left, central or total pancreatectomy.

3. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4.

4. Synchronous malignancy in other organs.

5. Previous underwent pancreatic resections.

6. Palliative surgery.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Periampullary Cancer
• Surgery

Intervention

Procedure:
• Total laparoscopic pancreaticoduodenectomy
Total laparoscopic pancreaticoduodenectomy
• Open pancreaticoduodenectomy
Open pancreaticoduodenectomy

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (16)

Lead Sponsor

Collaborator

Tongji Hospital

Af?liated Hospital of North Sichuan Medical College, First Affiliated Hospital of Chongqing Medical University, First Hospital of Jilin University, Fujian Medical University Union Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Henan Provincial People's Hospital, Hunan Provincial People's Hospital, Peking Union Medical College Hospital, Shandong Provincial Hospital, Sir Run Run Shaw Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Affiliated Hospital of Xuzhou Medical University, The Second Hospital of Hebei Medical University, The Third Affiliated Hospital of Soochow University, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Length of stay was defined as the postoperative time interval in days	Up to 24 months
Secondary	Estimated blood loss	The amount of blood loss during surgical procedure.	Up to 24 months
Secondary	Operation time	Time between first incision and last skin closure.	Up to 24 months
Secondary	Mortality	Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.	Up to 24 months
Secondary	Complication rate	Clavien-Dindo	Up to 24 months
Secondary	CCI	comprehensive complication index	Up to 24 months
Secondary	2 year survival	Overall survival rate for 24 months after surgery	Up to 24 months