An orthotopic resection surgical technique via inferior infracolic approach for laparoscopic pancreaticoduodenectomy: a randomized controlled trail

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300074333

Enrollment

Unknown

Registered

2023-08-03

Start date

2021-12-01

Completion date

Unknown

Last updated

2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumors of pancreatic head, ampulla and duodenum

Interventions

Control Group:Laparoscopic Pancreaticduodenectomy

Experimental Group:In situ Laparoscopic Pancreaticduodenectomy

Eligibility

Sex/Gender

All

Age

18 Years to 69 Years

Inclusion criteria

Inclusion criteria: a. Age < 70 years old. Preoperative laboratory and imaging examinations are highly suggestive of malignant tumors of the pancreatic head, ampulla and duodenum. b. Preoperative examination showed no distant metastasis and vascular invasion. c. No history of tumor in other parts or tumor resection. d. There is no basic disease that affects the patient's survival rate in the short term. e. The patient's family members and legal representatives signed the informed consent form to join the study voluntarily.

Exclusion criteria

Exclusion criteria: a. Intraoperative freezing and postoperative pathology confirmed IPMN, serous cystadenoma, mass chronic pancreatitis, autoimmune pancreatitis, etc. b. During the operation, it was found that the tumor had metastasized to the liver, omentum, mesentery, peritoneum and other organs and tissues, and invaded the celiac trunk, superior mesenteric vessels, inferior vena cava, and abdominal aorta. c. Serious diseases combined with other important organs, such as severe coronary heart disease, etc., but diabetes is not excluded

Design outcomes

Primary

Measure	Time frame
Compared with standard LPD, whether the surgical time, intraoperative bleeding, incidence of complications, and perioperative mortality of in situ LPD are higher than those of standard LPD, indicating the safety of the surgery;;Compared with standard LPD, can in-situ LPD reduce the probability of postoperative liver metastasis and local recurrence in patients, indicating the effectiveness of surgery.;	—

Measure

Time frame

Compared with standard LPD, whether the surgical time, intraoperative bleeding, incidence of complications, and perioperative mortality of in situ LPD are higher than those of standard LPD, indicating the safety of the surgery;;Compared with standard LPD, can in-situ LPD reduce the probability of postoperative liver metastasis and local recurrence in patients, indicating the effectiveness of surgery.;

—

Secondary

Measure	Time frame
Disease-free Survival, DFS;Overall Survival, OS;Quality of Life;	—

Countries

China

Contacts

Public ContactKE NENG WEN

West China Hospital, Sichuan University

kenengwen@scu.edu.cn+86 189 8060 6890

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026