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Completed

NCT Number: NCT04763642

The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

Completed

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ochapovsky Regional Clinical Hospital № 1

Krasnodar, Krasnodarskiy Kray, 350068, Russia

About this study

Minimally invasive surgery is undoubtedly the method of choice for multiple gastrointestinal surgical procedures because of its minimally invasive nature and number of benefits such as reducing postoperative pain, shorter hospital stays, and earlier return to work. Current advances in technological innovation and surgical strategies have made surgical procedures on the pancreas a routine practice. However, the use of new surgical techniques in pancreatic surgery has been slow due to the complexity of the operations and the steep learning curve required for their use. For example, minimally invasive pancreatoduodenectomies (MIPD) have not yet become widespread. Due to these interventions have a complex reconstructive stage MIPD are still performed in a very few centers by specialized surgeons.

Although laparoscopic PD was first described in 1994 and the robotic approach in 2003, MIPD still account for less than 14% of all DPE cases. The multicenter randomized controlled trial (LEOPARD-2) for the first time compared laparoscopic and open pancreatoduodenectomy for pancreatic or periampullary tumors. The study that involved 99 patients did not reveal the superiority of laparoscopic PD (LPD) and provided an estimated mortality of 6%; 5 patients died in the laparoscopy group and 1 patient died in the group open PD. The trial was stopped early due to high mortality in the migratory invasive interventions group. Therefore, advantages of minimally invasive procedures for removal of pancreato-biliary zone tumors remain controversial.

In our study, we analyzed perioperative surgical outcomes and short-term survival outcomes in patients undergoing MIPD, including LPD and robotic PD (RPD), as well as "open" proximal pancreatoduodenectomy (OPD).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 21-75 years
  • Clinically/histologically established diagnosis of the cancer;
  • Preoperative imaging assessment is resectable or borderline resectable

Exclusion criteria

  • Benign tumors of the head of pancreas;
  • Distant metastasis;
  • Conversion to laparotomy;
  • Instrumental findings of the tumor process prevalence;
  • General somatic status on the ASA III-V scale;
  • Acute pancreatitis;
  • Hyperbilirubinemia above 60 μmol/L (3.51 mg/dl) ((normal range, 4-20 μmol/L)).
  • Patients with intraoperative positive express-histological presence of tumor growth along the border of the pancreas resection

Treatment and study plan

Pancreaticoduodenectomy

Procedure

Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation

Primary outcomes

  1. Overall complications

    Time frame: up to 30 days

    The proportion of all complications after operation accounted for the total number of patients

  2. Pancreatic fistula

    Time frame: up to 30 days

    The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.

  3. Intra-abdominal bleeding

    Time frame: up to 30 days

    he International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.

  4. Intra-abdominal infection

    Time frame: up to 30 days

    Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.

Secondary outcomes

  1. Length of hospital stay (day)

    Time frame: Up to postoperative 2 months

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Other outcomes

  1. progression-free survival

    Time frame: Up to postoperative 3 years

    The period between the beginning of treatment and the observation of disease progression or the occurrence of death for any reason

Sponsors and collaborators

Lead sponsor

State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2021
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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