Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

656 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2022-05-01

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.

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Detailed Description

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Conditions

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Pancreatic Ductal Adenocarcinoma Surgery Periampullary Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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TLPD

Ttotal laparoscopic pancreaticoduodenectomy

Group Type EXPERIMENTAL

Total laparoscopic pancreaticoduodenectomy

Intervention Type PROCEDURE

Total laparoscopic pancreaticoduodenectomy

OPD

Open pancreaticoduodenectomy

Group Type EXPERIMENTAL

Open pancreaticoduodenectomy

Intervention Type PROCEDURE

Open pancreaticoduodenectomy

Interventions

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Total laparoscopic pancreaticoduodenectomy

Intervention Type PROCEDURE

Open pancreaticoduodenectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No