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NCT Number: NCT07087392

Inverted-Ω Anastomosis in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy

The goal of this clinical trial is to learn if inverted-Ω anastomosis after pancreatic head resection or mid-pancreatectomy works in benign or low-grade malignant tumor. It will also learn about the safety and feasibility of inverted-Ω anastomosis. The main questions it aims to answer are:

1. Does inverted-Ω anastomosis operate safely? (operative time, blood loss, transfusion and conversion rate) 2. What is the incidence and severity of postoperative complications in inverted -Ω anastomosis? What advantages does it have over conventional anastomosis methods such as roux-en-y?

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 to 75 years old, gender not limited;
  • Patients diagnosed with benign or low-grade malignant tumors in the head or middle section of the pancreas by CT or MRI;
  • ECOG score 0-1.

Exclusion criteria

  • Those with severe heart, liver or kidney insufficiency, or those who are assessed as intolerant to surgery or anesthesia, or those with ASA grade > 3;
  • Patients with a history of or concurrent other malignant tumors, or other serious infections or infectious diseases, or those who are unable to complete the anastomosis surgery;
  • Uncontrollable concomitant diseases, including but not limited to severe coronary artery disease, COPD or asthma, uncontrollable cerebrovascular diseases, symptomatic congestive failure, unstable angina pectoris, arrhythmia, or other diseases that the researchers consider ineligible for enrollment;
  • Patients who have undergone other upper abdominal surgeries and digestive tract reconstruction procedures in the past;
  • Patients requiring combined organ resection;
  • Preoperative assessment suggested that the patient might have factors such as active ulcers and bleeding in the digestive tract;
  • Pregnant and lactating women;
  • Any uncertain factors that have an impact on the patient's safety or compliance.

Treatment and study plan

Inverted-Ω Anastomosis

Procedure

After meeting the inclusion and exclusion criteria, duodenum-preserving pancreatic head resection or mid-pancreatic resection will be performed, and inverted-Ω anastomosis will be carried out during the operation for the reconstruction of the digestive tract

Primary outcomes

  1. Safety and assessment of the surgical process

    Time frame: During operation

    The incidence of intraoperative adverse events such as conversion to open surgery rate

  2. Operative time

    Time frame: During operation

    Operative time

  3. Intraoperative blood loss

    Time frame: During operation

    Intraoperative blood loss

  4. Postoperative complications

    Time frame: From the date of surgery (Day 0) up to 90 days postoperatively

    The incidence and severity of postoperative complications, as defined by the International Study Group on Pancreatic Surgery (ISGPS)

Secondary outcomes

  1. Short-term survival

    Time frame: From the date of surgery (Day 0) up to 3 years postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Modified Digestive Tract Reconstruction in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy: Inverted-Ω Anastomosis

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

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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