Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy

Conditions

Pancreatic Ductal Adenocarcinoma, Periampullary Cancer, Surgery

Keywords

pancreaticoduodenectomy, surgical outcome

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.

Tingting Qin, Hang Zhang, Shutao Pan, Jun Liu, Dewei Li et al. (33 authors)

Annals of Surgery2023-11-1523 citations

10.1097/sla.0000000000006149

Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours: a multicentre, open-label, randomised controlled trial.

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).

2021-04-27184 citations

10.1016/s2468-1253(21)00054-6

Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial

Hang Zhang, Yechen Feng, Junfang Zhao, Rufu Chen, Xuemin Chen et al. (21 authors)

BMJ Open2020-02-0124 citations

10.1136/bmjopen-2019-033490

Interventions

PROCEDURETotal laparoscopic pancreaticoduodenectomy

Total laparoscopic pancreaticoduodenectomy

PROCEDUREOpen pancreaticoduodenectomy

Open pancreaticoduodenectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Length of stay	Up to 24 months	Length of stay was defined as the postoperative time interval in days

Secondary

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

Countries

China

Outcome results

None listed