Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Ductal Adenocarcinoma, Surgery, Periampullary Cancer

Intervention / Treatment
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* Procedure: Total laparoscopic pancreaticoduodenectomy
* Procedure: Open pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven periampullary cancer, including pancreatic cancer, bile duct cancer, duodenal cancer, et al. Highly presumed malignancy with difficulties to obtain histological evidence. Preoperative staging work up performed by upper abdomen enhanced CT scan. The subject understands the nature of this trial and willing to comply. Ability to provide written informed consent. Patients treated with curative intent in accordance to international guidelines Exclusion Criteria: Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs. Subjects undergoing left, central or total pancreatectomy. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4. Synchronous malignancy in other organs. Previous underwent pancreatic resections. Palliative surgery.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TLPD<br>Ttotal laparoscopic pancreaticoduodenectomy | Procedure: Total laparoscopic pancreaticoduodenectomy<br>* Total laparoscopic pancreaticoduodenectomy<br>|
| Experimental: OPD<br>Open pancreaticoduodenectomy | Procedure: Open pancreaticoduodenectomy<br>* Open pancreaticoduodenectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Length of stay was defined as the postoperative time interval in days | Up to 24 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreaticoduodenectomy, surgical outcome