Modified Single-Incision Plus One-Port Versus Conventional Five-Port Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
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: Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy, Conventional Laparoscopic Pancreaticoduodenectomy.
- Who it may be relevant to
- Registry conditions: Ampullary Carcinoma, Duodenal Adenocarcinoma, Distal Cholangiocarcinoma. 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 "Single-Incision Plus One "Versus Conventional "Five-Port" Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas: Study Protocol for A Multicentre Randomised Controlled Trial
Overview
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
- Procedure Modified 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. - Procedure Conventional Laparoscopic Pancreaticoduodenectomy
A conventional laparoscopic pancreaticoduodenectomy performed using five trocar ports, followed by resection and reconstruction according to the standardized multicenter operative protocol.
Primary outcome measures
- Overall Survival Rate at 1 Year After Surgery [Time frame: From the date of surgery to 1 year after surgery]
- All-Cause Mortality Within 90 Days After Surgery [Time frame: From surgery through 90 days after surgery]
Secondary outcome measures (6)
- Overall Postoperative Complication Rate Within 30 Days [Time frame: From surgery through 30 days after surgery]
- R0 Resection Rate [Time frame: At final postoperative pathological assessment, up to 30 days after surgery]
- Operative Time [Time frame: During the index surgery]
- Disease-Free Survival Rate at 1 Year After Surgery [Time frame: From the date of surgery to 1 year after surgery]
- Conversion to Open Surgery Rate [Time frame: During the index surgery]
- Postoperative Length of Hospital Stay [Time frame: From surgery to hospital discharge, up to 30 days after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 4 centers
- The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) — Chongqing
- Nanfang Hospital, Southern Medical University — Guangzhou
- West China Hospital, Sichuan University — Chengdu
- The People's Hospital of Jianyang City — Jiancheng
Identifiers
NCT: NCT07744087 · NFEC-2026-403