Ampullary Carcinoma, Distal Cholangiocarcinoma, Duodenal Adenocarcinoma
Conditions
Brief summary
This multicenter, randomized, controlled, non-inferiority trial will compare modified single-incision plus one-port laparoscopic pancreaticoduodenectomy (mSILPD+1) with conventional five-port laparoscopic pancreaticoduodenectomy (CLPD) in adults with histologically confirmed or highly suspected non-pancreatic periampullary carcinoma who are candidates for pancreaticoduodenectomy. A total of 232 participants will be randomly assigned in a 1:1 ratio. Outcome assessors who adjudicate complications and interpret imaging will be masked to treatment assignment. The primary outcomes are all-cause mortality within 90 days after surgery and overall survival at 1 year after surgery. Secondary outcomes will assess postoperative complications, surgical performance, postoperative recovery, disease-free survival, quality of life, and health-care costs.
Interventions
PROCEDUREModified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy
A pancreaticoduodenectomy performed through a 60- to 80-mm periumbilical single-incision access platform containing three trocars, with one additional 12-mm laparoscopic port. Resection and reconstruction are performed according to the standardized multicenter operative protocol.
PROCEDUREConventional Laparoscopic Pancreaticoduodenectomy
A conventional laparoscopic pancreaticoduodenectomy performed using five trocar ports, followed by resection and reconstruction according to the standardized multicenter operative protocol.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older and younger than 75 years. * Histopathologically confirmed non-pancreatic periampullary carcinoma, or a high clinical suspicion of non-pancreatic periampullary carcinoma when preoperative pathological confirmation is unavailable. * Determined by preoperative multidisciplinary team evaluation to require pancreaticoduodenectomy. * Able to understand and comply with study procedures. * Able and willing to provide written informed consent before any study-specific screening procedure. * Expected to benefit from therapeutic pancreaticoduodenectomy according to applicable clinical guidelines.
Exclusion criteria
* Distant metastasis, including peritoneal, hepatic, distant lymph node, or other organ metastasis. * Requirement for distal, central, or total pancreatectomy, or another palliative procedure. * Preoperative American Society of Anesthesiologists physical status classification of 4 or higher. * Concurrent malignancy other than the target cancer. * Pregnancy or breastfeeding. * Severe psychiatric disorder that would interfere with study participation. * Receipt of neoadjuvant chemotherapy or radiotherapy before surgery. * Vascular invasion requiring vascular resection, as determined by the multidisciplinary team based on preoperative abdominal imaging. * Body mass index greater than 35 kg/m². * Participation in another clinical trial within the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival Rate at 1 Year After Surgery | From the date of surgery to 1 year after surgery |
| All-Cause Mortality Within 90 Days After Surgery | From surgery through 90 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Postoperative Complication Rate Within 30 Days | From surgery through 30 days after surgery | — |
| R0 Resection Rate | At final postoperative pathological assessment, up to 30 days after surgery | R0 resection rate, defined as the percentage of subjects without microscopic residual tumor on surgical margins based on final postoperative pathological assessment. |
| Operative Time | During the index surgery | — |
| Disease-Free Survival Rate at 1 Year After Surgery | From the date of surgery to 1 year after surgery | — |
| Conversion to Open Surgery Rate | During the index surgery | — |
| Postoperative Length of Hospital Stay | From surgery to hospital discharge, up to 30 days after surgery | Duration of hospitalization from the date of surgery until hospital discharge, reported as number of days. |
Countries
China
Contacts
CONTACTChenfenglin Yang
Outcome results
None listed