Inverted-Ω Anastomosis in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inverted-Ω Anastomosis.
- Who it may be relevant to
- Registry conditions: Pancreatic Cystic Neoplasms. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Modified Digestive Tract Reconstruction in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy: Inverted-Ω Anastomosis
Overview
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？
Interventions
- Procedure Inverted-Ω Anastomosis
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 outcome measures
- Safety and assessment of the surgical process [Time frame: During operation]
- Operative time [Time frame: During operation]
- Intraoperative blood loss [Time frame: During operation]
- Postoperative complications [Time frame: From the date of surgery (Day 0) up to 90 days postoperatively]
Secondary outcome measures (1)
- Short-term survival [Time frame: From the date of surgery (Day 0) up to 3 years postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital — Chengdu
Identifiers
NCT: NCT07087392 · 2025-550