Clinical trial NCT03138213: Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy
Official title: Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy(TJDBPS01) a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Surgery
Periampullary Cancer
Keywords: pancreaticoduodenectomy
surgical outcome
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
name: The Second Hospital of Hebei Medical University
name: The Affiliated Hospital of Xuzhou Medical University
name: Xinqiao Hospital of Chongqing
name: Hunan Provincial People's Hospital
name: The First Hospital of Jilin University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: The Third Affiliated Hospital of Soochow University
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Afﬁliated Hospital of North Sichuan Medical College
name: First Affiliated Hospital of Chongqing Medical University
name: Peking Union Medical College Hospital
name: Henan Provincial People's Hospital
name: Sir Run Run Shaw Hospital
name: Fujian Medical University Union Hospital
First posted: 2017-05-03
Enrollment: 656
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Length of stay
timeFrame: Up to 24 months
Secondary outcomes:
measure: Estimated blood loss
timeFrame: Up to 24 months
measure: Operation time
timeFrame: Up to 24 months
measure: Mortality
timeFrame: Up to 24 months
measure: Complication rate
timeFrame: Up to 24 months
measure: CCI
timeFrame: Up to 24 months
measure: 2 year survival
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References:
citation: Wang M, Li D, Chen R, Huang X, Li J, Liu Y, Liu J, Cheng W, Chen X, Zhao W, Li J, Tan Z, Huang H, Li D, Zhu F, Qin T, Ma J, Yu G, Zhou B, Zheng S, Tang Y, Han W, Meng L, Ke J, Feng F, Chen B, Yin X, Chen W, Ma H, Xu J, Liu Y, Lin R, Dong Y, Yu Y, Liu J, Zhang H, Qin R; Minimally Invasive Treatment Group in the Pancreatic Disease Branch of China's International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM). Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours: a multicentre, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol. 2021 Jun;6(6):438-447. doi: 10.1016/S2468-1253(21)00054-6. Epub 2021 Apr 27.
citation: Zhang H, Feng Y, Zhao J, Chen R, Chen X, Yin X, Cheng W, Li D, Li J, Huang X, Li J, Liu J, Liu J, Liu Y, Tan Z, Zhao W, Huang H, Li D, Yu Y, Wang M, Qin R. Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial. BMJ Open. 2020 Feb 10;10(2):e033490. doi: 10.1136/bmjopen-2019-033490.